Meghalaya High Court
Case BriefsHigh Courts

Meghalaya High Court : The Division Bench of Sanjib Banerjee, CJ. and W. Diengdoh, J. took cognizance of a petition in relation to the current health-care system. 

The State mentions the project funded by the World Bank in association with the Ministry of External Affairs that could see a sum of Rs. 371 crore invested in the State over a period of five years to augment the health-care system  acknowledging  that a lot more needs to be done to improve the health-care system. A report was brought on record revealing that smoking and drinking is the highest in the country in the North-East. Yet, there is no dedicated cancer hospital in the State. Though a cancer unit has been set up at the Civil Hospital in Shillong but it still does not have adequate equipment. It was pointed out that there are no facilities for conducting biopsy in the State however the State controverts saying that two units have been set up recently in Tura and in Shillong which are capable of cancer diagnosis. 

The Court agreed that a lot more needs to be done to improve the health-care facilities in the State and it is just not acceptable that after 75 years of independence the facilities would be as primitive as they are now. There is no doubt that funds are essential, but the lack of funds cannot be an excuse to perpetuate the lack of rudimentary medical facilities.

There has to be an almost revolutionary improvement in the facilities to bring it at par with what is generally available in the rest of the country. Funds have to be found and extraordinary attempts have to be made for such purpose.

The Court also believed that apart from better facilities being created, awareness drives need to be undertaken, particularly in the rural areas so that certain common bad practices are eradicated in due course. 

The matter is to be taken up on 13-07-2022. 

[In Re suo motu cognizance of deficiencies in health services in the State of Meghalaya v. Union of India, PIL No. 3 of 2016, order dated: 09-06-2022] 


Appearance:  

For the Petitioners : Mr C.C.T. Sangma, Adv.  

For the Respondents : Mr A. Kumar, Advocate-General with Mr S. Sengupta, Addl. Sr. GA Ms R. Colney, GA Mr K. Paul, Sr. Adv. with Ms R. Dutta  

Appearance in MC (PIL) No. 3 of 2017:  

For the Applicant : In person  

For the Respondent : Mr K. Paul, Sr. Adv. with Ms R. Dutta 


*Suchita Shukla, Editorial Assistant has reported this brief. 

Experts CornerMurali Neelakantan

About six years ago, or if you prefer, four years before the pandemic besieged the world, the world made a promise to itself. Well, the world actually made seventeen promises to itself, but we are focusing today on only one of them.

 

The sustainable development goals came into force on 1-1-2016. And one of these goals states as clearly as is possible the need to have universal healthcare for all. As if to drive the message home, the United Nations General Assembly High Level Meeting reaffirmed this goal in 2019.[1] But if one-sixth of humanity were to not meet this goal, it is difficult to envision how the world as a whole might succeed.

 

When it comes to universal healthcare for all, India needs to get a move on, not just for itself but for the rest of the world as well. Universal healthcare for all cannot be achieved without India, the pharmacy of the world.

 

We have the necessary ingredients, on the face of it. When it comes to pharmaceutical production by volume, India is the third largest producer in the world. When it comes to generic medications, there is nobody better than us. Fully 20% of the worldwide supply by volume is from India, and we meet about 60% of the global vaccination demand.[2] We can go on: one in every three generic pills consumed in the United States is manufactured by India, and in the UK, that number is one in four – but in the UK’s case, it is for all medicines, not just generic. India’s role in making generic drugs available for dealing with AIDS in Africa is one of the more unheralded stories of our time.[3]

 

How might we leverage these advantages to rise even higher, and move closer towards achieving the ambitious, but attainable goal of healthcare for all. In our view, this boils down to processes, products and people. Let us deal with each of these in turn.

 

Over time, our drug regulator has gained global credibility, and is today at maturity level 3. In English, this means that we have “stable, well-functioning and integrated regulatory systems”. Which sounds like, and is in fact, a good thing. But a better thing would be to reach level 4, which would indicate regulatory systems operating at an advanced level of performance and continuous improvement.[4] We assure you, this is all too attainable.

 

But this attainment will come only if we improve our processes, and by a lot! Arbitrary drug approval processes[5]for granting emergency use authorisation (EUA) for drugs such as Itolizumab, Remdesivir and Favipiravir and treatment like plasma therapy is indicative of a slapdash approach towards processes, at best. In the case of EUA, this is doubly problematic. Firstly because the Drugs Act does not even include a provision for granting EUA. And secondly, because the aftermath of the pandemic has revealed to us that these drugs are all but useless for COVID-19 and have resulted in pushing so many to poverty. This just shows how “immature” our drug regulatory processes are.

 

Remember also the many “herbal” and “homeopathic” remedies that were actively promoted by the Government. These have caused untold harm by reinforcing absurd beliefs of immunity in these concoctions peddled by the unscrupulous, but have also served to undermine the credibility of the drug regulator.

 

It gets worse. It would seem that the United States Food and Drug Administration (US FDA) has audited and inspected more Indian pharma manufacturers[6], and has enforced more regulatory actions than has the Indian drug regulator.[7] Further proof can be gleaned from the fact that only 100 drug units out of 8500 are WHO-GMP compliant, and only 300 drug units are US FDA compliant.[8] Spurious drugs and the lack of recall on the basis of the lack of quality are further indications that our processes simply are not good enough[9]. If we were to apply WHO-compliant good manufacturing practice (GMP) norms in this country, a large number of the 4200 MSME drug units would likely face severe challenges – and that is likely an understatement.[10]

 

Let us turn our attention to products next. We have and there really is no other way to put this shot ourselves in the foot by imposing many non-tariff and regulatory barriers to generic medicines. This is true of the Global South at large, but that is surely cold comfort, if that. Contrast this with Europe, where generics gain access to wider markets immediately upon patent expiry. We would strongly recommend a system of “passporting” Indian drugs, especially to the Global South, so that approval for a particular drug in one country will mean approval in all countries where we have standing agreements.

 

In our opinion, India has missed many golden opportunities to integrate with and help nations of the Global South. This could, and should have been done in the case of both the green and the white revolutions.These were missed opportunities and that has diluted India’s global influence over the decades. Now that there exists an opportunity to be a leader when it comes to providing universal healthcare, we think it imperative that India steps up to the mark, and shows the way to other nations. The world needs India because there is currently no alternative for low cost high quality medicines[11]. This was the sweet spot for India during the IT revolution of the 1990s.

 

Finally, as regards products, our wishlist may well sound long, but each of the items on it are eminently attainable. We need a dramatic increase in the number of Jan Aushadhi stores[12], INN[13] prescriptions (as opposed to brand name prescriptions), fixed trade margins to prevent rampant profiteering, government interventions on the supply side (most notably in the case of centralised procurement) and finally, a dramatic rationalisation of the many healthcare schemes that are offered by the Government across multiple levels.

 

Or, to put it more succinctly, what we need is universal healthcare, rather than universal health insurance where it is the insurers who profit off patients. We have seen the irreversible damage private health insurance has done to healthcare in the United States and we have also seen the benefits of universal free healthcare in Europe.

 

Our final point is about the most important grouping of them all: People. Our treatment of frontline healthcare workers has been nothing short of shameful during the pandemic, and we argue that we haven’t exactly covered ourselves in glory in this regard even before 2020. No healthcare system can function well without well trained, well respected and well compensated healthcare workers, and we don’t think we do a good enough job in any of these cases. Whether it be overworked doctors on strike during the pandemic, understaffed medical establishments, [14] or the shoddy treatment meted out to Anganwadi workers, or hundreds of other examples – we need to do better as a nation.

 

Universal healthcare for all is an aspirational yet attainable goal. But for us to get there, we need to dramatically improve our processes and our products. But above all, we need to do better by the people who work in this sector. As the meme goes, the best time to get started was yesterday. The next best time? Right now.

 


Murali Neelakantan is the principal lawyer at amicus. He was formerly global general counsel at Cipla and global general counsel and executive director at Glenmark

†† Ashish Kulkarni teaches courses in economics and statistics at the Gokhale Institute of Politics and Economics, Pune, and blogs at econforeverybody.com 

[1] See HERE.

[2] See HERE .

[3] See HERE.

[4]See HERE.

[5]See, Fifty-Ninth Report on the Functioning of the Central Drugs Standard Control Organisation (CDSCO) available HERE .

[6]Center for Drug Evaluation and Research Office of Pharmaceutical Quality Report on the State of Pharmaceutical Quality: Fiscal Year 2019 HERE .

[7]See HERE .

[8] See HERE.

[9] See, Katherine Eban, Bottle of Lies: The Inside Story of the Generic Drug Boom (2019) for a deep investigative report on India’s many problems with the pharma industry.

[10] See HERE.

[11]See HERE.

[12]See HERE.

[13] See HERE.

[14] See HERE

Experts CornerShantanu Mukherjee


Introduction


Telemedicine usage spiked early in the COVID-19 Pandemic as consumers and providers sought safe ways to access and deliver healthcare. The healthcare profession had to react swiftly to deal with the social distancing measures put in place to assist flatten the curve of COVID-19 infections. At the peak of the epidemic, hospitals, clinics, and physicians looked to telemedicine for a method to deliver the same level of care while limiting the spread of the coronavirus. Key trends in the utilisation of technology have evolved, which will continue to impact the future of telemedicine services.

 

This necessary step change was made possible by the following factors: (1) increased consumer desire to utilise telemedicine; (2) increased provider willingness to use telemedicine; and (3) regulatory improvements that allow for more access and payment. During the pandemic’s tragedy, telemedicine provided a bridge to care, and it now provides an opportunity to rethink virtual and hybrid virtual/in-person care models, with the objective of improving healthcare access, results, and cost.

 

By bringing AI to the edge, telemedicine has evolved patient care and experience through accessibility, which was invaluable for treating COVID-19 as well as curbing its spread.  In FY 2021, the Indian Telemedicine Market was valued at USD 1314.83 million and is predicted to develop at a healthy Compound Annual Growth Rate (CAGR) of roughly 22.31 per cent.

 

This is attributed to the country’s strengthening healthcare IT infrastructure, as well as India’s expanding digitalisation. Furthermore, the rising incidence of chronic and infectious illnesses in the nation, along with a dearth of healthcare workers and doctors, is predicted to drive market expansion through FY 2027.

 

Through remote patient monitoring, for example, physicians were able to use internet connected, at home devices to track the health of high-risk individuals, like the elderly and post-op patients, while minimising their exposure.

 

Telemedicine connects healthcare professionals with patients using new technology such as kiosks, online monitoring programmes, mobile phone applications, wearable devices, and videoconferencing. This article will investigate different telemedicine rules in several worldwide jurisdictions, as well as offer a more in-depth look at the Indian situation.

 


What is Telemedicine?


Telemedicine/telehealth can be understood as the delivery of healthcare services by healthcare professionals using information and communication technologies for the exchange of valid information for the diagnosis, treatment, and prevention of disease and injuries, as well as continuing education of healthcare providers and research and evaluation, all in the interests of advancing health.

 

According to the Centers for Disease Control and Prevention (CDC), telemedicine use increased by more than 154% in late March 2020 when compared to the same time in 2019. Furthermore, according to current Fortune Business Insights forecasts, the industry will be worth more than $397 billion USD by 2027. To demonstrate the effect of the epidemic, the market was only worth $42 billion USD in 2019. While utilisation has declined since the pandemic’s height, it is obvious that telemedicine is now an important component of the future of healthcare delivery.

 

Telemedicine use has stabilised at 38 times pre-pandemic levels as of July 2021. Even before to the epidemic, research suggested increasing usage of telemedicine. In a McKinsey poll, 76 per cent of patients stated they would be interested in adopting telemedicine in the future. Furthermore, in research published in the Journal of Telemedicine and Telecare, more than half of respondents stated they would use telemedicine to refill prescriptions, prepare for an impending visit, check test findings, or obtain instruction.

 

A number of nations have established telemedicine practice guidelines. Telemedicine practice standards, not to be confused with the standard of care or scope of practice, are regulations and restrictions that clinicians must follow while practising medicine through telemedicine and often do not apply to in-person treatment. Patient informed consent to telemedicine services, specific disclosures on the provider’s website, mandatory forwarding of the patient’s medical records to the patient’s other caregivers, restrictions on the type of telemedicine technology/modality that can be used, and requirements for in-person examinations are examples of practice standards. Thus, providers must comprehend and follow nation-specific practice requirements, or risk being sanctioned by the Board of Medicine.

 

Many nations passed new telemedicine laws and guidelines in 2020, altering previous practice standards, permitted modalities, and prescription criteria. Changes included removing face-to-face assessments, practising primarily over the phone, and lifting telemedicine mode prescription limits. Some of these modifications were implemented by legislation, while others were made through executive order or regulation. During the pandemic, many of the alterations were just transient (with expiration dates that, confoundingly, often did not match the federally declared public health emergency date).

 

These exemptions produced a telemedicine regulatory environment that was more concerned with achieving the standard of medical care for a specific patient than of the technological modalities of care delivery (e.g., audio-video versus asynchronous). The American Telemedicine Association (ATA) aided in this endeavour by publishing sample policy wording for State telemedicine laws to serve as a reference source for best practices. This trend toward technology neutral telemedicine legislation is expected to continue in 2022, with stakeholders stressing the relevance of medical standard of care and clinical quality of services above proscriptive modality restrictions.

 


Leveraging AI and Telemedicine


According to MIT research, 75% of healthcare facilities that used AI recognised an enhanced capacity to manage ailments, and 4/5 claimed it proactively helped reduce worker fatigue. With COVID-19 placing a burden on both sectors (amount of clinical information and related patients, as well as increased clinician workload), AI in telemedicine is a strong strategy for the future of medical delivery. Years ago, advances in computers and artificial intelligence made cutting-edge telemedicine applications viable. Policy has been a major impediment to complete implementation until recently. Telemedicine has enhanced patient care and experience via accessibility by bringing AI to the edge, which has been helpful for treating COVID-19 as well as controlling its spread.

 

Physicians, for example, were able to employ internet connected, at home equipment to follow the health of high-risk populations, such as the elderly and post-op patients, while reducing their exposure via remote patient monitoring. This is a game changer, not just because it provides doctors with unprecedented levels of insight into their patients, but also because the more these technologies are employed, the more innovation they enable. For example, Intel is collaborating with Medical Informatics Corporation (MIC) to assist hospitals in centralising and analysing data from devices that monitor patients’ vital signs, reducing the frequency with which care teams must round on patients and reducing “alarm fatigue” by triaging the patients to whom they must respond.

 

AI and edge powered telemedicine has also enabled physicians and hospitals to interact in novel ways, pooling resources during crucial periods. Telemedicine, will have an influence on every aspect of healthcare. In the not too distant future, for example, psychiatric care teams may utilise AI enhanced, high definition videoconferencing to evaluate patients’ facial clues to get a deeper grasp of their emotional states in the present.

 

The most common AI applications in telemedicine include data analysis and cooperation, remote patient monitoring, and intelligent diagnosis and help. The potential of AI may be used to complement doctors’ skills to diagnose and treat patients, reduce physician burnout, and improve the overall patient experience. Due to the continuing public health issue, the emphasis on AI and telemedicine remains a significant push for healthcare executives looking to stay competitive by improving clinician processes and uncovering predictive potential via patient data analysis.

 


Global perspectives on Telemedicine


The constraints on travel imposed by COVID-19 in many areas of the globe have prompted Governments to see the promise of telemedicine and, overnight, alter laws and regulations to allow healthcare practitioners to install telemedicine systems. Many Governments have implemented telemedicine measures in a matter of weeks that would have normally taken years to evaluate and implement. There are several possibilities in the telemedicine arena for existing organisations, firms contemplating expanding into telemedicine, and startups.

 

Healthcare providers are increasingly reaching across borders to give medical services directly to overseas patients and doctors via the use of technology. While hospitals, colleges, research institutes, and healthcare firms have always been involved in global health activities, current communications technology has permanently transformed the delivery paradigm. Today, offering services to patients and doctors situated halfway across the world requires synchronous and asynchronous communication technologies such as e-mail, interactive video, and smartphone applications that aid in diagnosis, consultation, treatment, monitoring, and even medical research. Remote second opinions, in which a healthcare practitioner is requested to confirm a diagnosis or treatment from a distance by either a physician or a patient, have also increased in the worldwide medical industry.

 

International telemedicine is rapidly expanding. Even with a basic internet connection, telemedicine services offer convenience, increased access to experts, cost savings, and collaborations among healthcare providers from other nations. All of this has the potential to improve health outcomes. And, as the globe prepares for public health events like the COVID-19 Epidemic, harnessing telemedicine to battle illness is critical.

 

Although the practice of medicine is regulated globally, telemedicine does not necessarily fall under the conventional realms of legislation and regulation relevant to the medical profession and thus it requires more stringent regulations and monitoring.

 


                Regulations for Telemedicine in the United States of America


While telemedicine is typically permitted in the United States, it is exceedingly complicated and heavily regulated, both in terms of general practice and coverage. There is no federal legislation that controls telemedicine practice. Telemedicine is governed at the State level, and the definition of acceptable telemedicine activities varies widely. States often define telemedicine differently, with some allowing asynchronous connections and others requiring only real-time interactive voice and video chats. In addition to the rules governing telemedicine practice, there are significant differences in telemedicine coverage and payment at both the State and Federal levels.

 

The Medicare Program insures US seniors aged 65 and over, as well as some persons with qualifying impairments. Despite exceptions to Medicare’s Telemedicine Payment Policy, present laws discourage broad adoption and usage of e-health and create a precedent for other big commercial insurers. The Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act was proposed in the United States Senate in 2017, however it has yet to move. This legislation proposes removing Medicaid’s geographical constraints and, if approved, would increase coverage of telemedicine services. As a consequence, telemedicine services would be afforded the same Medicaid validity as in-person appointments, perhaps inspiring other insurers to adjust their private policies.

 

The Health Insurance Portability and Accountability Act of 1996 (HIPAA) is a piece of US law that establishes data privacy and security safeguards for medical information. Its goal is to eliminate healthcare fraud and abuse by establishing industry-wide standards for healthcare data on electronic billing and other operations. It also necessitates the safeguarding and secure processing of sensitive patient health information. This is addressed by the privacy rule and the security rule, and it is very important in telemedicine.

 

Several commercial insurers have followed suit and are either paying healthcare providers for telemedicine services or directly offering telemedicine access to their members as part of their benefits. Previous rules are also being relaxed, including the expansion of covered telemedicine services and the ability for new patients to be treated through telemedicine rather than just those with a prior connection. Penalties for HIPAA breaches in telemedicine are now waived when Healthcare Personnel (HCP) behave in good faith in the face of the COVID-19 Pandemic.

 

Furthermore, in order to assist telemedicine, practitioners who are licensed out of State and in good standing are permitted to practice beyond State boundaries. The Federal Communications Commission has just established a $200 million coronavirus telemedicine initiative. Variations in acceptance and disparities in legislative frameworks among States have been one of the barriers to telemedicine adoption. These differences call for a government telemedicine policy push to standardise and expedite an overall framework that might increase telemedicine’s penetration throughout the United States.

 

Virtual visits increased dramatically as a result of these legislative changes. Now that virtual care has gained broad acceptance and adoption, regulators, politicians, and industry executives are advocating for permanent reforms that will allow for the ongoing widespread use of telemedicine post-pandemic. We are witnessing new legislation initiatives at both the Federal and State levels, and we anticipate substantial changes in the coming years. While most of this reform will take time, there is a strong desire and motivation at both the Federal and State levels to advance rules that would allow for sustained telemedicine access.


Telemedicine Regulations in the United Kingdom


There are no explicit laws that govern telemedicine in general. Instead, healthcare practitioners will be subject to the same regulations, licensing and registration requirements, and professional standards of conduct that apply to their specific area as they would if the service was performed in-person. At the moment, no legislation or regulations in the United Kingdom directly cover telemedicine.

 

The Care Quality Commission (CQC) is England’s healthcare provider regulator (with Northern Ireland, Scotland, and Wales each having its own regulator). To offer remote medical advice, the CQC requires all service providers to register. Providers must demonstrate to the CQC that the care and treatment they provide will fulfil the criteria of the Health and Social Care Act, 2008 and its accompanying regulations. This implies that digital suppliers of medical advice are subject to the same regulatory framework as non-digital providers.

 

Telecommunications corporations such as BT, Virgin Media, and Sky in the United Kingdom (UK) have committed to help the National Health Service (NHS) carry out telemedicine for healthcare practitioners. Primary care, clinical trials, counselling, and chronic illness evaluations are all being delivered through telemedicine. The Government had previously declared a centrally sponsored “long term plan” to minimise the number of outpatient presentations prior to COVID-19. This has to be implemented considerably quicker than planned due to the rising demand for telemedicine to replace outpatient appointments. Regulators have recognised that providing healthcare through telemedicine may provide an extra degree of risk to patients, which must be addressed by the healthcare practitioner. As a result, a number of UK authorities and trade organisations have attempted to provide guidelines to the professions they supervise.

 

As an example, in April 2019, the General Pharmaceutical Council provided guidelines on delivering online pharmacy services, outlining the actions pharmacists may take to ensure they continue to satisfy the standards required of them.

 

In response to the COVID-19 Pandemic, the General Medical Council released recommendations to help physicians in giving remote consultations and actions they may take to maintain patient safety.

 

The British Medical Association, a trade union and professional association for physicians in the United Kingdom, has recently produced guidelines on how to conduct patient consultations via videoconference. Any healthcare practitioner interested in using telemedicine in the UK should verify that they have the proper licensing and registration for the healthcare services they offer, as well as evaluate any accessible and relevant guidelines published on best practice for remote service provision.

 

Given the recent surge in telemedicine usage, it is expected that regulators will continue to react with any applicable recommendations or rules of behaviour, unique to the healthcare service that they supervise. This is likely to be the case if any regulatory loopholes are discovered, as indicated by the CQC on its website. Legislation may often fall behind technology changes, and as a result, it is probable that this sector will be subject to more examination and legal modifications in the future.


Telemedicine Regulations in China


China has a significant urban-rural health disparity, which large telemedicine networks such as the International MedioNet of China Network, Golden Health Network, and People’s Liberation Army Telemedicine Network have been unable to bridge. The National Health Commission and the National Administration of Traditional Chinese Medicine issued new e-healthcare rules in September 2018 in order to expand telemedicine capabilities and develop the telemedicine industry. This includes advice on commercial company hospital cooperation, telemedicine diagnostics, patient permission, and third-party collaborations. This expanded telemedicine definitions beyond physician-to-physician consultations to include physician to patient contacts, although implementation and regulation remain unclear.

 

In China, remote medical care delivery utilises both proprietary systems and the use of generic remote messaging applications such as WeChat. According to the good administrative practice for remote medical services (for trial implementation), the inviter institute for remote medical services may directly invite the invitee institute to provide technical support for the inviter institute’s medical treatment activities via telecommunications, computer and network technology, and so on. On the other hand, the inviter institution or a third-party organisation may also build a proprietary platform for remote medical care supply.

 

Online healthcare platforms, like those in other Asian countries, are expected to see significant increases in market share in the coming years, particularly following COVID-19, with companies offering direct-to-patient telemedicine subscriptions such as Good Doctor, Alibaba, and Tencent experiencing growth. China is also pioneering contactless technologies, such as a Smart Field Hospital experiment in Wuhan at COVID-19, in which patient care is given by robots and digital gadgets.


Telemedicine Regulations in Australia


In Australia, there are presently no rules or regulations governing telemedicine. Existing rules and regulations governing healthcare delivery apply to telemedicine. Various regulatory and industry organisations in the healthcare profession, however, have issued guidance notes on the delivery of services through telemedicine. For example, the Australian Health Practitioner Regulation Agency (AHPRA), the federal organisation in charge of regulating healthcare professionals in Australia, has released telemedicine information for practitioners on its website (AHPRA guidance). According to the AHPRA guidance, all registered health practitioners may utilise telemedicine as long as it is safe, clinically acceptable for the healthcare being delivered, and appropriate for the patient. The AHPRA guidance further points out that no special equipment is necessary to offer telemedicine services, and that services may be delivered using phone and publicly accessible video chatting applications and software.

 

However, the AHPRA guidance notes that free versions of applications (i.e. non-commercial versions) may not comply with applicable security and privacy laws, and practitioners must ensure that their chosen telecommunications solution meets their clinical requirements, their patient’s or client’s needs, and satisfies privacy laws. In addition to the current “Good Medical Practice: A Code of Conduct for Doctors in Australia,” the Medical Board of Australia has issued online “guidelines for technology-based patient consultations”. The Royal Australian College of General Practitioners (RACGP) has also issued a “guide to conducting telephone and video consultations in general practise”.


Telemedicine Regulations in Europe


The danger of COVID-19 in Europe has required the necessity for patient-accessible telemedicine services. Telemedicine firms such as France’s Doctolib and Qare, Sweden’s LIVI, the United Kingdom’s Push Doctor, and Germany’s CompuGroup Medical SE have all witnessed significant gains in European acceptance. Telemedicine is regarded as both a health service (Directive 2011/24/EU) and an information service (Directives 95/46/EU, 2000/31/EC, and 2002/58/EC) in Europe. A Europe-wide framework is far from being implemented due to the absence of Pan-European common medical responsibility and medical legal rules.

 

Throughout the epidemic, Germany has persistently stayed at the forefront of the digital health change by constantly developing and adjusting laws. DiGA Fast Track was established in 2019 as a result of the Digital Healthcare Act (DVG) and other legal reforms, which meant that applications could be prescribed by physicians and expenses could be paid via German health insurance. Two health applications were legally accessible for prescription on October 5, eleven months after the German Federal Government enacted the DVG.

 

France passed a new healthcare legislation in 2019, based on the Government’s “My Health 2022” strategy, which aims to broaden the country’s e-health emphasis. France intends to improve interoperability; roll out nationwide electronic health records (EHR) to become the cornerstone of e-health platforms; leverage the use of AI in health; establish a data hub for healthcare data sets; and invest further in the public health system’s recent introduction of telemedicine.

 

Telemedicine use has been smashing records in the nation, leading Health Minister Olivier Véran to issue a directive to make it easier to practise telemedicine. Furthermore, the nation has just begun trials for a digital vaccine passport and is making good progress in using health technology to return the country to normalcy. Now, the International Chamber of Commerce (ICC) AOKpass app will be trialled for travellers travelling to the French Caribbean Territory of Martinique and Guadeloupe.


Telemedicine Regulations in India


The Board of Governors (BoG) of the Medical Council of India (MCI), the erstwhile medical education regulator in India that prepared the guidelines in consultation with the premier planning body, the NITI Aayog (National Institution for Transforming India), has attempted to fill an important gap: a lack of legislation and a framework for ethical telemedicine practise. The recommendations identify video, audio, and texting as three means of communication and specify the conditions for practitioners to utilise them, including constraints.

 

As stated in the background of the aforementioned guidelines, the purpose of these guidelines is to provide practical advice to doctors in order for them to begin using telemedicine as part of their normal practice, as well as to provide them with a sound course of action to provide effective and safe medical care based on current information, available resources, and patient needs to ensure patient and provider safety, to be used in conjunction with national clinical standards.

 

The guidelines comprehensively set out the standards, norms, and procedures to be followed by any person who has enrolled in the State Medical Register or the Indian Medical Register under the Indian Medical Council Act (Registered Medical Practitioner/RMP) while practising telemedicine in India through any mode of communication viz. video, audio, or text-based communication, either for exchange of information in real time or in synchronous modes for first consults or follow up patients. The guidelines require RMPs to complete an online training session offered by BoG within three years of the guidelines’ announcement.


Individuals That Are Certified To Provide Telemedicine


Under the guidelines, any individual who is registered in the State Medical Register or the Indian Medical Register (RMP) under the Medical Council Act, 1956 is competent to perform telemedicine.

 

RMPs who intend to practise telemedicine must finish an obligatory online course made accessible by the BoG within three years after notification. Until then, the principles outlined in the guidelines must be observed. The same ethical principles and standards that apply to in-person medical consultations apply to telemedicine.


Telemedicine Consultation Procedure


The guidelines recommend the following procedure, which must be followed by RMP providers.

Consultation using telemedicine

Commencement of consultation and consent – The patient initiates the telemedicine consultation by phone call, video, or text. Following that, the RMP may agree to conduct the consultation. The permission is inferred when the patient initiates the telemedicine session.

Identification – RMP should authenticate the patient’s identity to his satisfaction by asking for the patient’s name, age, address, e-mail ID, phone number, or any other suitable identification.

Brief evaluation – Before providing the telemedicine consultation, a quick examination of the patient should be performed to identify the state of the patient’s health. If the patient’s condition necessitates emergency treatment, the RMP should advise on first aid or other urgent relief, as well as provide assistance.

Information exchange – The RMP must exercise his professional judgment and ask the patient to supply the necessary information (complaints, other consults, medication details, documentation, etc.). The RMP may continue with the consultation after he is satisfied with the information. If the RMP considers that the information supplied is insufficient, he should terminate future telemedicine consultation and recommend in-person consultation. The RMP should keep an accurate record of the whole information exchange with the patient.

Patient management – If the RMP is satisfied with the foregoing information, the RMP may elect to give the patient with particular medications, counselling, or advice/information. The RMP must also keep a complete record of the patient.


Important Telemedicine Consultation Rules and Principles


  1. Initial consultation

The necessity for patient identification is not required for follow-up appointments (those consultations which are given within six months of in-person consultation). If a new symptom appears, it should be treated as the initial consultation.

The RMP must determine whether to employ text, audio, or video communication.

When offering telemedicine consultation, the RMP should exercise professional judgment and should recommend in-person consultation if it seems essential. Emergency treatment or consultation should normally be done in person, however the RMP may continue with telemedicine consultation if it is urgent and suitable in his professional opinion.

RMP has the option to cancel the consultation at any moment and refer the patient for an in-person appointment, and the patient has the same option.

  1. Medications

(a) From time to time, the Central Government may announce drugs (other than those previously specified in Annexure 1 to the guidelines) that may be prescribed through teleconsultation, as well as any limits that may apply, in the following categories:

(i) List O: Medicines that are safe to prescribe through any means of teleconsultation, such as those used for common diseases (paracetamol, ORS solutions, and so on) or those judged required during public health crises.

(ii) List A: Medicines that may be given during the initial video consult and are re-prescribed for refill in the event of a follow-up. This would be a list of medications that are reasonably safe and have a low risk for misuse.

(iii) List B: Medicines that may be provided to a patient receiving a follow-up consultation in addition to those recommended during the in-person consultation for the same medical condition.

(iv) Prohibited list: Prescription only medications.

(b) RMP must provide the patient a picture, scan, or digital copy of the signed prescription by e-mail or any messaging platform.

(c) The prescription should be in accordance with the code of conduct and should not violate the Drugs and Cosmetics Act, 1940 or the regulations enacted under them.

(d) When a prescription is sent directly to a pharmacy, the patient’s express agreement is required. Such a prescription should only be issued to the patient’s preferred pharmacy.

  1. Maintaining Confidentiality

The code of conduct, as well as the IT Act and other data protection requirements, will apply to RMPs who provide teleconsultation.

All information supplied by the patient must be kept secret, and the RMP must take appropriate precautions while using platforms to ensure such confidentiality.

RMP is expected to capture all facts and keep a complete record of the patient, including any documents or information utilised for the consultation and prescriptions.

  1. Cost

RMP may charge a reasonable fee, and telemedicine consultations are to be regarded in the same manner as in-person consultations.

RMP is required to provide a receipt/invoice for the price charged for telemedicine consultation.


Impact of the Guidelines


Telemedicine practice in India has now been given legal standing, thanks to the processes and norms outlined in the guidelines and the code of conduct. These guidelines are extensive and cover every element and the Board of Governors has been assigned the task to:

  • Amend the guidelines if necessary.
  • Issue the medications list under the guidelines.
  • As needed, provide instructions, recommendations, or explanations about these guidelines.

 

Any infraction committed while using telemedicine would be deemed misconduct at the hands of the responsible RMP under the code of conduct. As a result, if the misbehaviour is proven, the RMP may be punished, or their registration may be suspended or terminated.

 

These guidelines herald the beginning of a new era for India’s pharmaceutical business. Patients no longer have to drive to hospitals and wait in large lines to see a doctor for minor issues. The guidelines have cleared the path for consultations to be conducted through any kind of communication medium while still preserving the patient’s interests. This is particularly important given the situation in India as a result of COVID-19, which has made many people unable to obtain healthcare adequately.


Future Modifications and Reforms


The advancement of information technology has had a profound effect on society. Telemedicine refers to the transmission of medical information and knowledge through telecommunications and computer technologies in order to enhance patient diagnosis, treatment, and management. Telemedicine includes distant learning, medical peer review, patient education efforts, and other related activities.

 

The internet, mobile phones, and e-mail are all new areas for healthcare practitioners to explore, and they should proceed with caution. Telemedicine has medicolegal consequences for registration, licensure, insurance, quality, privacy, and secrecy, as well as other dangers involved with electronic healthcare communication. Another critical factor is the physician-patient connection, as well as the quality of care and informed consent. These complex concerns are further compounded by the lack of any legislation or laws, particularly concerning matters such as professional negligence, obligations, liabilities, and fines in such instances. Additional concerns in telemedicine, telemedicine, teleconsultation, telemonitoring, tele-treatment, and patient information records must be addressed.

 

Telemedicine’s reach is expanding, as is the quality assurance of its services. Telemedicine, like the standardisation of information technology, is a growing sector for effective care delivery with standardised information exchange.

 

Despite differences in telemedicine adoption throughout the globe, it is understood by various jurisdictions that telemedicine helps improve health system performance and needs further regulation. Telemedicine has taken a springboard trajectory in the COVID-19 era, as governments and partnerships formed have forged a way to support and accelerate its rollout, particularly in developed countries. During COVID-19, telemedicine proved companies’ capacity to provide excellent care remotely (at home) while simultaneously lowering expenses. This is expected to continue beyond the COVID-19 time-frame, as telemedicine services are strengthened and expanded. Moving on, one area that deserves special emphasis is increasing the use of telemedicine among sub-specialties to supplement primary care. Building relationships among many stakeholders and encouraging open innovations are developing roles that will enable the advantages of telemedicine to reach disadvantaged geographies.

 

Once the COVID-19 phase is finished, regional efforts such as Pan-European initiatives may be considered in terms of acceptable regulatory and governance structures. International initiatives to build a public health preparation framework with telemedicine at the centre of public health response during epidemics like COVID-19 are necessary and countries such as India have taken calls to action in this regard which has spearheaded a new wave of e-health regulations.


† Shantanu Mukherjee, Founder, Ronin Legal.
†† Vatsala Sood, Intern, Symbiosis Law School, Pune.
Case BriefsSupreme Court

Supreme Court: The 3-judge bench of Dr. DY Chandrachud, L. Nageswara Rao and S. Ravindra Bhat, JJ has expressed serious concerns on the ability of the marginalized members of society between the ages of 18-44 years to avail COVID-19 vaccination, exclusively through a digital portal in the face of a digital divide and has said,

“A vaccination policy exclusively relying on a digital portal for vaccinating a significant population of this country between the ages of 18-44 years would be unable to meet its target of universal immunization owing to such a digital divide. It is the marginalized sections of the society who would bear the brunt of this accessibility barrier. This could have serious implications on the fundamental right to equality and the right to health of persons within the above age group.”

CoWIN Portal and how it works

According to the Union of India,

(i) The CoWIN portal enables one person to register 4 persons using the same mobile number;

(ii) All gram panchayats in the country have Common Service Centres which can effectively enable people residing in rural areas to register online for the vaccination;

(iii) Citizens who do not have access to digital resources could take help from family, friends, NGOs and CSCs;

(iv) Walk-ins cannot be permitted due to the scarcity of vaccines and fears of over-crowding at centres. The online registration requirement counters this fear and also effectively monitors the administration of the second dose. The policy may be re-considered subsequently when more vaccines are available;

(v) Identity proofs are required for the purpose of determining age and keeping a track of persons who are due for the second dose. However, in recognizing the issues arising with the insistence of one of the seven prescribed photo-ID proofs, the Central Government issued an SoP dated 23 April 2021 which enables bulk registration of certain identifiable groups, such as homeless persons, who would be identified and registered by the District Immunization Task Force; and

The Centre clarified that walk-in vaccination facilities will continue for persons over the age of 45 years in separate, designated vaccination centres. This is because vaccinations have been underway for this age group for a while and overcrowding has not been experienced so far.

Data, Drawbacks, and the Digital Divide

In the order, where the Court sought clarification from the Centre on various issues relating to the COVID-19 Vaccination policy, it relied on vaiours reports and surveys that highlighted that:

  • Around 4% of the rural households and 23% of the urban households possessed a computer. In the age group of 15-29 years, around 24% in rural households and 56% in urban areas were able to operate a computer; and
  • Nearly 24% of the households in the country had internet access during the survey year 2017-18. The proportion was 15% in rural households and 42% in urban households. Around 35% of persons in the age group of 15-29 years reported use of internet during the 30 days prior to the date of survey. The proportions were 25% in rural areas and 58% in urban areas.
  • Out of the total population of 1.3 billion, only 578 million people in India (less than 50%) have subscription to wireless data services. The wireless tele density in rural areas is 57.13% as compared to 155.49% in urban areas as on 31 March 2019. The report stated that: “[this] reflects the rural-urban divide in terms of telecom services‟ penetration. Since, the number of wireless data subscribers are less than 50% of the total wireless access subscribers, the number of wireless data subscribers in rural areas would be much lower”.
  • In a few Indian States like Bihar, Uttar Pradesh and Assam the tele density is less than 75%; and
  • The monthly income of persons living below the poverty line in urban areas and rural areas is Rs 1316 and Rs 896, respectively. However, to access internet data services, a minimum tariff plan would cost around Rs 49, which includes 1 GB data every 28 days. This would constitute 4-5% of the month‟s income of such persons accessing data. As such, the report notes that this would bear a considerable cost for persons living below the poverty line.
  • While there are 2,53,134 Gram Panchayats in India, as on 31 March 2020 only 2,40,792 Gram Panchayats are covered with at least one registered Common Service Centres. Hence, approximately 13,000 Gram Panchayats in India do not have a Common Service Centres.
  • The CoWIN platform is not accessible to persons with visual disabilities. The website suffers from certain accessibility barriers. These include:

(i) Audio or text captcha is not available;

(ii) The seven filters, which inter alia, include age group, name of vaccine and whether the vaccine is paid or free, are not designed accessibly. This issue can be addressed by creation of a drop-down list;

(iii) While visually challenged persons can determine the number of available vaccine slots, one cannot find out the day those slots correspond to. This can be resolved by ensuring that table headers correspond to associated cells;

(iv) Keyboard support for navigating the website is absent;

(v) Adequate time should be given to disabled users to schedule their appointment without the possibility of being automatically logged off; and

(vi) Accessibility protocols, such as use of appropriate colour contrasts, should be adhered to

“… there exists a digital divide in India, particularly between the rural and urban areas. The extent of the advances made in improving digital literacy and digital access falls short of penetrating the majority of the population in the country. Serious issues of the availability of bandwidth and connectivity pose further challenges to digital penetration.”

Clarifications sought from the Government:

“It may not be feasible to require the majority of our population to rely on friends/NGOs for digital registrations over CoWIN, when even the digitally literate are finding it hard to procure vaccination slots.”

  • The issue of over-crowding may also arise at CSCs in rural areas where people would have to visit constantly in hope of a vaccine slot opening up.
  • Certain vaccination centres may be earmarked for on-site registrations for the population aged between 18-44 years without the existing conditions prescribed in the circular dated 24 May 2021, potentially with a view to prioritize those with co-morbidities/disabilities/other socio-economic vulnerabilities. Alternatively, whether specific daily quotas may be introduced for on-site registration at each centre or specific centres.
  • This policy may not allay the issue of hesitancy which may arise from approaching a State authority (such as the District Immunization Task Force) to obtain registration for the vaccination. Whether on-site registration with selfattestation of age to ensure widespread vaccination can be provided.
  • The CoWIN platform and other IT applications like Aarogya Setu should be made available in regional languages. The timeline for ensuring the availability of the platform in multiple regional languages.
  • Conducting a disability audit for the CoWIN website and other IT application like Aarogya Setu to ensure that they are accessible to persons with disabilities.

[In re: Distribution of Essential Supplies and Services During Pandemic, 2021 SCC OnLine SC 411, decided on 31.05.2021]


Appearances before the Court

Mr Tushar Mehta, learned Solicitor General

Mr Jaideep Gupta and Ms Meenakshi Arora, learned Senior counsel and Amici

ALSO READ

COVID-19 Vaccination Policy| Supreme Court seeks clarifications from Centre on these five issues

Case BriefsSupreme Court

Supreme Court: The 3-judge bench of Dr. DY Chandrachud, L. Nageswara Rao and S. Ravindra Bhat, JJ has, in a bid to understand the vaccination policy for COVID-19, has sought clarification from the Central Government on various aspects enumerated below. While doing so, the Court clarified that,

“This Court is presently assuming a dialogic jurisdiction where various stakeholders are provided a forum to raise constitutional grievances with respect to the management of the pandemic. Hence, this Court would, under the auspices of an open court judicial process, conduct deliberations with the executive where justifications for existing policies would be elicited and evaluated to assess whether they survive constitutional scrutiny.”

Vaccine Procurement and Distribution among Different Categories of the Population

Asking UoI to undertake a fresh review of its vaccination policy, the Court has sought clarification on the following:

  • The roadmap of projected availability of vaccines till 31 December 2021;
  • The preparedness with respect to specific needs of children in the event of a third wave of the pandemic in terms of medical infrastructure, vaccination trials and regulatory approval, and compatible drugs;
  • Whether under the policy of the UoI, it is permissible for State/UT Governments or individual local bodies to access vaccine supplies of foreign manufacturers;
  • The number of crematorium workers vaccinated in phase 1. A targeted drive can be conducted for vaccination of the remaining crematorium workers;
  • The State/UT Governments are diverting the vaccines (procured by them at a higher price than Central Government) for the persons in the age group of 18- 44 years to vaccinate persons above 45 years of age, due to a shortage of vaccines being supplied by the Central Government. The manner in which the Central Government will factor this quantity and price differential into their subsequent allocation and disbursal of vaccines to States/UTs for the persons above 45 years of age; and
  • The mechanism for redistribution, if the 25:25 quota in a particular State/UT is not picked up by the State/UT Government or the private hospitals.

Effects of Vaccination by Private Hospitals under the Liberalized Vaccination Policy

“… we are not opposed to the involvement of private hospitals in the vaccination drive. Private health care institutions have an important role as well. The UoI has correctly noted in its affidavit that these hospitals will reduce the burden on government facilities. This was also happening earlier for the vaccination of those above 45 years of age, where the Central Government was providing these hospitals with vaccines and they were allowed to charge patients a nominal fee (Rs 250). However, the issue is about the effect of privatizing 50% of all vaccines available for the 18-44 age group.”

  • The manner in which Central Government will monitor the disbursal of vaccines to private hospitals, specifically those who have hospital chains pan India. Further, whether (i) private hospitals are liable to disburse vaccines pro rata the population of States/UTs; and (ii) the mechanism to determine if private players are genuinely administering the lifted quota in that State/UT alone. The UoI shall place on record any written policy in relation to this.
  • Whether the Central Government conducted a “means-test” of the demographic of a State/UT to assert that 50% of the population in the 18-44 age group would be able to afford the vaccine. If not, the rationale for private hospitals being provided an equal quota for procurement as the State/UT Governments.
  • The manner in which the Centre and States/UTs shall ensure an equitable distribution of vaccines across sections of the society, and how this factors into the rationale of equal apportionment between State/UT Governments and private hospitals.
  • The nature of the intervention with respect to the final, end-user price that is being charged by private hospitals, especially when a cap on procurement by the private hospitals has been set.

Basis and Impact of Differential Pricing

If the Central Government’s unique monopolistic buyer position is the only reason for it receiving vaccines at a much lower rate from manufacturers, it is important for us to examine the rationality of the existing Liberalized Vaccination Policy against Article 14 of the Constitution, since it could place severe burdens, particularly on States/UTs suffering from financial distress.”

While the Court commended the co-operative efforts of the UoI and the private manufacturers in developing and distributing vaccines which are critical to mitigate the pandemic, it sought clarifications on the process of development and augmentation of vaccine production and its pricing for States/UTs and private hospitals.

  • Since the Central Government has financed (officially, Rs 35 crores to BBIL and Rs 11 crore to SII for phase 3 clinical trials) and facilitated the production (or augmentation of production) of these vaccines through concessions or otherwise, it may not be accurate to state that the private entities have alone borne the risk and cost of manufacture. Additionally, the Central Government would have minimized the risks of the manufacturers by granting Emergency Use Authorization to the vaccines, which should factor into its pricing.
  • The manner in which public financing is reflected in the procurement price for the Central Government, which is significantly lower than price for the State/UT Governments and private hospitals. Given that the R&D cost and IP have either been shared between the Central Government and the private manufacturer (in case of Covaxin) or the manufacturer has not invested in R&D of the vaccine (in case of Covishield), the manner in which the pricing of vaccines has been arrived at, with the Central Government refusing to intervene statutorily. The justification for intervening in pre-fixing procurement prices and quantities for States/UTs and private hospitals, but not imposing statutory price ceilings.
  • Comparison between the prices of vaccines being made available in India, to their prices internationally.
  • Whether ICMR/BBIL formally invited contracts for voluntary licensing and if so, whether they have they received viable offers. The manner in which the UoI is independently trying to assist manufacturers for developing BSL3 labs which are essential for Covaxin production.

Vaccine Logistics

  • The manner in which cold storage equipment capacity is being balanced between the Central and State/UT Governments. The manner in which the States/UTs are managing the logistical burden for vaccinating persons aged between 18-44 years, along with persons aged over 45 years.
  • Whether cold storage facilities in India have increased for the COVID-19 vaccination drive; the present numbers, and comparison with the numbers prior to March 2020;
  • Whether the cold storage equipment is indigenously manufactured or is imported. If it is imported, the steps which have been taken to start indigenous manufacturing.
  • The steps being taken to improve the cold storage management for vaccines which may require lower temperature to be stored, compared to the ones which currently have approval in India.

Digital divide

“… there exists a digital divide in India, particularly between the rural and urban areas. The extent of the advances made in improving digital literacy and digital access falls short of penetrating the majority of the population in the country. Serious issues of the availability of bandwidth and connectivity pose further challenges to digital penetration. A vaccination policy exclusively relying on a digital portal for vaccinating a significant population of this country between the ages of 18-44 years would be unable to meet its target of universal immunization owing to such a digital divide. It is the marginalized sections of the society who would bear the brunt of this accessibility barrier. This could have serious implications on the fundamental right to equality and the right to health of persons within the above age group.”

  • It may not be feasible to require the majority of our population to rely on friends/NGOs for digital registrations over CoWIN, when even the digitally literate are finding it hard to procure vaccination slots.
  • The issue of over-crowding may also arise at CSCs in rural areas where people would have to visit constantly in hope of a vaccine slot opening up.
  • Certain vaccination centres may be earmarked for on-site registrations for the population aged between 18-44 years without the existing conditions prescribed in the circular dated 24 May 2021, potentially with a view to prioritize those with co-morbidities/disabilities/other socio-economic vulnerabilities. Alternatively, whether specific daily quotas may be introduced for on-site registration at each centre or specific centres.
  • This policy may not allay the issue of hesitancy which may arise from approaching a State authority (such as the District Immunization Task Force) to obtain registration for the vaccination. Whether on-site registration with selfattestation of age to ensure widespread vaccination can be provided.
  • The CoWIN platform and other IT applications like Aarogya Setu should be made available in regional languages. The timeline for ensuring the availability of the platform in multiple regional languages.
  • Conducting a disability audit for the CoWIN website and other IT application like Aarogya Setu to ensure that they are accessible to persons with disabilities.

Final directions

The Court directed UoI to file an affidavit, with each of the abovementioned issues responded to individually and no issue missed out.

The affidavit should also provide the following information:

  • The data on the percentage of population that has been vaccinated (with one dose and both doses), as against eligible persons in the first three phases of the vaccination drive. This shall include data pertaining to the percentage of rural population as well as the percentage of urban population so vaccinated;
  • The complete data on the Central Government‟s purchase history of all the COVID-19 vaccines till date (Covaxin, Covishield and Sputnik V). The data should clarify: (a) the dates of all procurement orders placed by the Central Government for all 3 vaccines; (b) the quantity of vaccines ordered as on each date; and (c) the projected date of supply; and
  • An outline for how and when the Central Government seeks to vaccinate the remaining population in phases 1, 2 and 3.
  • The steps being taken by the Central Government to ensure drug availability for mucormycosis.

The affidavit is to be filed within 2 weeks.

[In re: Distribution of Essential Supplies and Services During Pandemic, 2021 SCC OnLine SC 411, decided on 31.05.2021]


Appearances before the Court

Mr Tushar Mehta, learned Solicitor General

Mr Jaideep Gupta and Ms Meenakshi Arora, learned Senior counsel and Amici

Case BriefsHigh Courts

Delhi High Court: The Division Bench of Vipin Sanghi and Jasmeet Singh, JJ., dealt with a petition which prayed for waiver of import and other duties on Amphotericin B, which is a drug being used for treatment of Mucormycosis (Black Fungus).

Counsel for the respondent informed the Court that Import Duty payable on import of Amphotericin B was 27 % wheareas the counsel for the petitioner informed it to be 70 %. Counsel for the respondent however submitted that there is complete waiver of customs duty on life saving drugs imported for personal use via a notification and on instructions, Amphotericin B would be covered by the said notification.

The Court was of the view that the said drug is required to save lives of the people suffering from the disease which is inflicting thousands of people all over the country, and there is acute shortage of the same in the country, and that the Central Government should seriously consider waiver of complete Customs and other duties & levies on the import of the said drug by all, at least, for the period that the same is in short supply in India and is required to treat the disease, namely Mucormycosis (Black Fungus).

The Court directed that if any import is made by any person of the said medicine, the same may be cleared by accepting a bond (to the effect that in case the duty is payable and not waived, the same shall be paid) from the importer without actual payment of duties till a final decision on the said aspect is taken. The Court will hear the matter on 01-06-2021.

[Laieq Ahmad Siddiqui v. Govt. of NCT of Delhi,  2021 SCC OnLine Del 2986, decided on 27-05-2021]


Suchita Shukla, Editorial Assistant had put this report together 

For the petitioner: Mr Rohit Sharma

For the respondent: Mr Rahul Mehra, Senior Advocate along with Mr Gautam Narayan, ASC & Mr Satyakam, ASC with Mr Aditya P. Khanna, Ms Dacchita Sahni, Ms Ritika Vohra and Mr Chaitanya Gosain, Advocates for the respondent/ GNCTD.

 Mr Amit Mahajan, Mr Kirtiman Singh & Ms Nidhi Mohan Parashar, CGSCs for the respondent/ UOI.

Mr Ashish Mohan, Advocate for respondent No.3/ SGRH.

Mr Rajshekhar Rao, Senior Advocate (Amicus Curiae) along with Mr Anandh Venkataramani, Ms Mansi Sood, Ms Sonal Sarda and Mr Areeb Amanullah, Advocates.

Mr Krishnan Venugopal, Senior Advocate with Mr Manan Verma, Mr Aditya N Prasad, Mr Kaushik Mishra & Ms Anmol Srivastava, Advocates.

Gauhati High Court
Case BriefsHigh Courts

Gauhati High Court: The Division Bench of Sudhanshu Dhulia, CJ., and Manash Ranjan Pathak, J., addressed the issues relating to situation under the Covid-19 pandemic in the Tea Gardens of Assam and conditioner of workers in these Tea Gardens.

The petitioner submitted before the Court that there are about 800 Tea Gardens and 434 Tea Estates in Assam. The concern of the petitioner was that the Guidelines of the Government of India relating to management of COVID management were not being followed in these Tea Gardens and the Plantations Labour Act, 1951 and the Rules framed therein were also not being followed inasmuch as the COVID Care Centres within the Tea Gardens were taking care of only asymptomatic patients. The petitioner had raised other concerns as well, particularly, need for creation of Post COVID Clinic for treatment of patients, who had suffered from COVID and need to be advised on various aspects after their recovery.

On the other hand, the counsel for the state, Mr. D. Saikia argued that the Government had been conscious of the health of workers in these Tea Gardens and out of 800 Tea Gardens, vaccination had already started in 208 of these Tea Gardens, out of which 28000 workers had been vaccinated and out of these 2000 had also received their second dose. The counsel further submitted other figures showing that the situation is not as alarming as is being made out.

In the light of above the Bench directed the State to submit a written reply showing as to whether test are being done and what kind of test is being done, for determination of COVID-19 infection. Regarding the Mobile Medical Units (MMU) and their use in these Tea Gardens, the Bench said,

We have absolutely no doubt that since the Government already has the resources, these Mobile Medical Units must be put in use for testing and other purposes in the Tea Gardens as well, if not already being done.”

[Anjan Nagg V. Union Of India, 2021 SCC OnLine Gau 1105, decided on 24-05-2021]


Kamini Sharma, Editorial Assistant has put this report together 

Appearance before the Court by:

Counsel for the Petitioner: Mr. W. Sharma
Counsel for the Respondent: Asstt.S.G.I

Case BriefsHigh Courts

Bombay High Court: The Division Bench of Ravindra V. Ghuge and B. U. Debadwar, JJ., addressed the issue of dysfunctional ventilators supplied through PM Cares Fund. The Bench remarked,

We find the above situation as regards the dysfunctional ventilators supplied through the PM Cares Fund, to be quite serious. We, therefore, call upon the learned ASGI to state, as to what action would the Union of India initiate in these circumstances.

MUCORMYCOSIS TREATMENT

The State had submitted before the Court that about 1000 hospitals were empanelled in two schemes namely, ‘MJPJAY’ and ‘PMJAY’for treating patients. Out of these 1000 hospitals, 131 were specifically identified as being appropriate facilities for treating Mucormycosis treatment free of cost. It was also submitted that non-governmental hospitals which were amongst these 131 hospitals would be prohibited from charging as per their normal rates while treating patients for Mucormycosis considering the decision of the Government to extend free treatment in such facilities to all the residents of Maharashtra. Further, those private hospitals which were not empanelled under the said schemes would not be covered by the Government Resolution and if any Mucormycosis patient desires to approach a hospital which is not empanelled under the said two schemes, he would have to pay the charges as per the bills raised by such private hospitals.

P. M. CARES FUND VENTILATORS

Insofar as the 150 ventilators received through the PM Cares Fund were concerned, the State government indicated that a company by name, Jyoti CNC had manufactured the said 150 ventilators with the model name ‘Dhaman III’. It was highlighted before the Court that the GMCH had deployed 17 ventilators of which 6 were flawed and was likely to impact the treatment process of the patients. Two extremely serious flaws pertaining to ‘no in-let O2 pressure’ display and ‘patient becoming hypoxic’when on ventilator were noticed which could be life threatening.

It was further demonstrated that 41 ventilators were allotted to 5 private hospitals with the rider that they would not claim ventilators charges from the patients who used them but not a single ventilator was functional and the hospitals had declined to utilise them as a serious threat to the life of the patients exists. Similarly, 37 ventilators available with the GMCH had yet not been un-boxed as the Dean of the GMCH decided not to un-box the remaining 37 ventilators as 113 ventilators which had been put to use suffer from malfunctioning. It was clarified that, on the other hand all the 64 ventilators supplied by several Industrial Establishments were perfectly operational. Considering the above mentioned, the Bench remarked,

We find a serious issue before us as regards the defective functioning of the ventilators. Except the 37 ventilators which are yet to be un-boxed, 113 ventilators put to use are found to be defective.

Noticing some of the politicians have started visiting the Government Medical College and Hospital to find out whether the ventilators are functioning properly or not and some of the politicians have declared that all the ventilators are in good working conditions and some have stated that as the ventilators were lying idle, they have become dysfunctional. Opining that political colour should not be attached to the issue of dysfunctional ventilators as it would cause more botheration to the medical faculty than render assistance, the Bench remarked,

We express our displeasure as regards such indulgence by the people’s representatives. Contrary statements are being issued by the politicians which we find distasteful as some politicians have visited the hospital, posing as if they have the knowledge and the expertise to inspect the ventilators and recommend correctional steps.

In the above backdrop, holding that the situation as regard to the dysfunctional ventilators supplied through the PM Cares Fund was quite serious, the Bench asked the ASGI to state as to what action would the Union of India initiate in these circumstances and what remedial steps would it take.

[Registrar (Judicial) v. Union of India, 2021 SCC OnLine Bom 751, Order dated 25-05-2021]


Kamini Sharma, Editorial Assistant has put this report together 

Appearance before the Court by:

Amicus Curiae: Satyajit S. Bora
For State of Maharashtra: Chief PP D. R. Kale
For Union of India: ASGI Ajay G. Talhar
For the respondent 8: Adv. S. G. Chapalgaonkar
For the respondent 22: Adv. K. N. Lokhande
For the respondent 25: Adv. R. K. Ingole

Case BriefsForeign Courts

Federal Court of Canada: The Bench of Gagné, Associate CJ., upheld the validity of one pneumococcal vaccine patents pertaining to Prevnar 13 owned by Pfizer’s Wyeth LLC while held the other two patents invalid.

Finally, if the Court were to side with Wyeth on the construction of Claim 1, the Court would have to choose a cap on the number of serotypes covered by the invention or…the ambit of Wyeth’s monopoly could grow over the life of the 363 Patent as new serotypes – or their structure – are discovered.

Background

The Merck Canada Inc. and Merck Sharp & Dohme Corp. (together Merck) had sought to  impeach three Canadian patents, one composition patent and two formulation patents, property of Wyeth LLC, pertaining to a 13-valent pneumococcal polysaccharide protein conjugate vaccine commercialized under the name Prevnar® 13. Evidently, Merck had filed a New Drug Submission to sell a 15-valent pneumococcal polysaccharide protein conjugate vaccine [V114] in Canada, apprehending that Wyeth may try to use its patents to block V114 from entering the Canadian market, Merck persuaded to challenge its validity.

Analysis by the Court

Merck argued that each of claims 1 to 6, 13, 14, 17 to 19, 22 to 30 and 36 to 38 of the 363 Patent [the Impugned Claims] were invalid. The 363 Patent was issued on June 16, 2015 which included three groups of claims: (i) Composition Claims; (ii) Use Claims; and (iii) Method/Process Claims. Claim 1 described a multivalent immunogenic composition comprising 13 distinct conjugates prepared from 13 serotypes each individually conjugated to CRM197. The Bench opined that the PSA (Person of Skill in the Art) would have understood that the 363 Patent describe the “next generation” of Wyeth’s conjugate development program and that Wyeth had managed to exceed the known limits of serotype coverage with its PCV-13 and that the 363 Patent describe a “platform” technology disclosing the details of Wyeth’s conjugation technology that were needed in order to replicate its success. The PSA would have used the platform to add other serotypes in a future vaccine, just as Merck did with its V114.

The Bench opined that both Claim 1 and the 363 Patent in its entirety indicated that Claim 1 was limited to 13 serotypes as there were sufficient bases for adding adjuvants, buffers and other excipients. However, there is no basis to go beyond 13 serotypes. Moreover, the Summary of the Invention described the invention as providing a 13-valent pneumococcal conjugate composition comprising the seven serotypes contained in Prevnar 7 (4, 6B, 9V, 14, 18C, 19F and 23F), plus six additional serotypes (1, 3, 5, 6A, 7F and 19A), which was specific and limited. There was no mention in the 363 Patent of a need, a desire, or a basis for adding any other serotype. Again, all of the 16 examples provided in the 363 Patent, which contain instructions needed by the PSA, refer only to the specific 13 serotypes recited in the claims, no others.

Hence, the Bench held that Claim 1 of the 363 Patent was limited to 13 serotypes and did not disclose any “platform” for making a vaccine with greater coverage.

Validity of 368 Patents

 Obviousness

Analyzing the two sets of claims challenged by Merck: i) the Composition Claims; and ii) the Method/Process Claims, the Bench said that Merck had failed to meet the burden to prove that the difference between the inventive concept of the Composition Claims and the state of the art was obvious to the PSA and that the PSA would have expected that if you made the 13-valent PCV conjugated with CRM197, it would be immunogenic. Opining that conjugating is a complex endeavor and that the increasing reports on immune interference could have deterred the skilled person to pursue a 13-valent PCV all conjugated with CRM197, the Bench agreed with Wyeth that the composition of independent Claims 1 and 17 were not found in the prior art. The state of the art did not include an immunogenic composition comprising 13 individual pneumococcal conjugates (including 6A and 19A) using CRM197 as a single carrier protein. Accordingly, the composition Claims 2-5, 18 and 19, which depend directly or indirectly on Claims 1 and/or 17, by adding an adjuvant (or specific adjuvant(s)), were also not obvious at the priority date. Similarly, refuting the obviousness of the process claim, the Bench said that since the Claims 1 and 17 were neither “obvious” nor “obvious to try”, the invention disclosed in the Method/Process Claims would not have been achieved by the PSA without prolonged and arduous experimentation. Therefore, it was not “obvious to try” either.

Validity of the Formulation Patents

The 056 Patent and 111 Patent together were referred to as the Formulation Patents which were assailed by Merck for anticipation, obviousness and double patenting. Regarding the question of obviousness, the Court held that the invention as claimed would have been obvious to the PSA and the Formulation Patents were invalid for obviousness, with the exception of the serotype selection claims that were invalid for double patenting. As 7-valent claims (Claims 19 of the 056 Patent and Claim 20 of the 111 Patent) were obvious as of April 2006. Prevnar 7 had been on the market for years and was well known. Agreeing with  Merck, the Bench held that the formulations disclosed in the Formulation Patents (except for the serotype selection claims) would have been obvious to the PSA in light of the common general knowledge and the state of the art. Similarly, it would have been obvious to try to obtain stability by adding a surfactant. Therefore, there was nothing inventive about trying a surfactant to see if it would work in a polysaccharide-protein conjugate formulation and the same was an obvious solution to a well-known problem.

Double Patenting

The doctrine of double-patenting prevents a patentee from “evergreening” or from extending the monopoly given by a first patent by filing a new patent that did not disclose a new invention to the public. Noticing that the 111 Patent claimed a formulation comprising the same ingredients, the Bench said that as in 2005-2006, the use of a siliconized container means would have been obvious. Also, the 056 Patent broadly claimed a formulation containing one or more polysaccharide protein conjugates, a pH buffered saline solution with a pKa of about 3.5 to 7.5, and a surfactant. Opining that adding a surfactant to a polysaccharide protein conjugate vaccine was routine, common, and would have been obvious, the Bench held that  the claims of the Formulation Patents were all obvious variants of the invention claimed in the 363 Patent that claims a composition of 13 specific pneumococcal polysaccharides conjugated to the carrier protein CRM197 in a buffer with aluminum phosphate. The 13-valent claims (Claims 18 and 20 of the 056 Patent and Claims 19 and 21 of the 111 Patent) of the Formulation Patents were therefore held invalid for obviousness-type double patenting.

Verdict

In the backdrop of above, the Bench opined that Merck had partly succeeded in meeting its burden and in establishing that Claim 1 of the 363 Patent was limited to 13 serotypes and that no particular level of immunogenicity should be read into Claim 1 of the 363 Patent. However, the Bench reached to the conclusion that Claims 1-6, 13-14, 17-19, 22-30, and 36-38 of the 363 Patent were valid, though limited to 13 serotypes. The Formulation Patents were invalid for obviousness, with the exception of the serotype selection claims that were held invalid for double patenting. As a result, Claims 1-3, 6-15, 17-24, and 29-38 of the 056 Patent as well as Claims 1-12, 17-28 of the 111 Patent were held to be invalid, void, unenforceable and of no effect.

[Merck Sharp & Dohme Corp. v. Wyeth LLC, 2021 FC 317, Decided on 30-04-2021]


Kamini Sharma, Editorial Assistant has put this report together 

Case BriefsHigh Courts

Karnataka High Court: A Division Bench of Chief Justice and Aravind Kumar J. gave a slew of directions regarding vaccine allocation, oxygen supply, food security and dignified burial of COVID dead bodies.

Issue 1: Delay in test result reporting

The Court taking stock of the situation in light of a recent incident where a staff of High Court died due to covid as the test result was not communicated to the deceased on time and hence he could not take treatment for COVID-19.

Directions:

  • State Government must initiate appropriate action in accordance with law against all concerned who are responsible for this lapse and place on record a report on the action taken on the next date.
  • State Government shall issue a direction to all the Laboratories to ensure that such incidents are not repeated and test reports are made available within 24 hours.

Issue 2: Vaccine Allocation

About 26, 00,000 beneficiaries in the State who have taken the first dose of COVISHIELD or COVAXIN have not received the second dose though it is overdue as per the prevailing norms of the Central Government. The total stock of vaccines available in the State is only 9, 37,780 of doses. Hence, there is no possibility of majority of 26, 00,000 beneficiaries getting the second dose which is already overdue. The situation which prevails today clearly shows that if all the available 9, 37,780 doses are to be used for administering the second dose, a substantial number of beneficiaries who have taken the first dose will not get the second dose.

The Court observed that there cannot be any distinction between the words ‘due’ and ‘overdue’ when it comes to administration of the second dose. Once as per the existing timelines, the second dose is due, it is an obligation of the Governments to ensure that the second dose is provided. If the second dose is not provided, it will be a violation of the fundamental rights of the citizens under Article 21 of the Constitution of India.

The Court further observed that If those who have taken the first dose are not administered the second dose on the respective due dates, apart from violation of the fundamental rights of the said citizens under Article 21 of the Constitution of India, if they are required to take the first dose again, it will be a huge national waste of the first dose already administered to them.

A mandatory direction to both the Governments regarding ensuring sufficient procurement of quantity of vaccine doses however was not issued in light of submission made by the Additional Solicitor General. It was stated that a decision on allocation of vaccine is likely to be taken and it was assured that the Central Government will make every endeavour to bridge the gap to ensure that no one is denied the second dose which has become due.

The sum and substance of the guidelines by the Central Government appears to be that the first priority of the State Government should be to provide vaccine to those who have taken the first dose.

“By way of an illustration, we may record here that if a person has taken the first dose of COVISHIELD more than eight weeks back, he must get priority over the person who has completed seven weeks from the date of taking the first dose of COVISHIELD. Thus, it is mandatory for the State Government to ensure that a rational and fair formula is adopted for giving second dose of vaccination.”

Directions:

  • State Government must abide by the said guidelines considering the desperate and critical situation created due to failure to administer second dose to about 20,00,000 citizens.
  • State Government shall place on record all the facts and figures (district-wise) regarding the second dose administered throughout the State

Issue 3: Food Security

The Government of India decided to allocate free of cost food grains at 5 Kgs, per person, per month to nearly 80 crore beneficiaries covered under the National Food Security Act, 2013 (NFSA) over and above NFSA Food grains for next two months i.e. May and June 2021 on the same pattern as the earlier “Pradhan Mantri Garib Kalyan Anna Yojana (PM-GKAY)”. Under this Special scheme (PM-GKAY) around 80 crore NFSA beneficiaries covered under both the categories of NFSA, namely Antyodaya Anna Yojana (AAY) and Priority Householders (PHH) will be provided with an additional quota of free of cost food grains (Rice/wheat) at a scale of 5 Kgs per person, per month, over and above their regular  monthly entitlements under NFSA.

There is an issue regarding implementation of the instant scheme which is being implemented through Indira Canteens throughout the State.

 Directions:

  • It is directed to both the Governments to take a call on the issue whether the benefits of Atma Nirbhara Scheme as applicable last year can be extended to those who are not holding a ration card of any State.
  • State Government shall also identify the vulnerable sections of the society who have been affected by the partial lockdown.
  • State Government shall take a decision immediately on the issue of restoring Dasoha helpline to know who are the persons who are deprived of the benefits of the scheme of the State Government of supplying cooked food as well as well as the scheme of the Central Government.

Highlights of the Report of the Monitoring Committee of the Karnataka State Legal Services Authority

There are two main issues which arise on the basis of the said report. These are as follows:

  • Compensation in Chamarajanagar District Hospital Tragedy

The Court relied on judgments Rudul Sah v. State of Bihar 1983 (4) SCC 141 and Nilabati Behera v. State of Orissa, AIR 1993 SC 1960 and observed “that in a public law remedy in the form of a petition under Article 226 of the Constitution of India, Writ Court can grant compensation for violation of the fundamental rights guaranteed under Article 21 of the Constitution of India.”

  • Responsibility for lapses

The Court observed that the Committee has found instances of tampering with the relevant record. The Court directed that “the record shall be retained in the custody of the Chief Secretary will continue to operate. Needless to add that either the Commissioner appointed under the Commission of Inquiry Act, 1952 or any Investigating Agency needs to look into the record, the Chief Secretary will make available the said record.”

Observations regarding Oxygen

“….it is for the State Government to immediately communicate the requirements of the State to the concerned Authority of the Central Government in view of the assurance recorded therein.”

Observations regarding Dignified Burial or Cremation

The Court observed

“….State Government permit burial of the body of a person who has died due to COVID-19 without obtaining a death certificate.””

The Court finally directed “the learned Advocate General or the learned Additional Advocate General convenes a meeting of the learned counsel appearing for the parties so that the issues regarding compliances can be discussed and a proper response is given on the next date”

[Mohammed Arif Jameel v. Union of India, 2021 SCC OnLine Kar 12301, decided on 13-05-2021]


Arunima Bose, Editorial Assistant has put this report together.

Gauhati High Court
Case BriefsHigh Courts

Gauhati High Court: The Division Bench of Sudhanshu Dhulia, CJ. and Manash Ranjan Pathak, J., took up a PIL wherein the counsel of the petitioner, Mr A. Chamuah had filed an interlocutory application stating that in Assam persons who were suffering from COVID, although they had an insurance cover were still not being admitted in private hospitals inspite of directions issued in this regard for taking care a COVID patients (who have insurance cover), vide order of the Regulatory Authority dated 04-03-2020.

Mr D. Saikia, Advocate General, Assam placed on record before the Court that on enquiry being done at their end, nine private hospitals were contacted in Guwahati, Dibrugarh and Bongaigaon and the replies which they had received from these private hospitals is that inspite of the late payment in many cases, have not denied admission to a patient suffering from covid, except in some cases where the employees of the hospital were also suffering from COVID. Enquiries have also been made regarding the old lady, who was allegedly denied treatment from cancer as she was suffering from COVID.

The Court granted one week time to Assistant Solicitor General of India, Mr R.K.D. Choudhury to get instructions from the Insurance Regulatory Authority and to file a detailed reply regarding the same so that there is a better position to examine the matter. Court to hear the matter on 31-05-2021.

[Lawyers Association, Guwahati v. State of Assam, 2021 SCC OnLine Gau 1100, decided on 24-05-2021]


Suchita Shukla, Editorial Assistant has put this report together 

Case BriefsHigh Courts

Bombay High Court: The Division Bench of Dipankar Datta, Cj., and G. S. Kulkarni, J., expressed its displeasure on casual attitude of the authorities in complying with the Court’s orders. The Bench, while criticizing the strategy adopted by the State government for allocation of Remdesivir drug to the hospitals, said,

“The allotment of Remdesivir appears to have been made on the basis of ‘functional bed capacity’ of each of the hospitals. Such allocation whether would cater to the actual need of the patients has not been explained to us.”

The Bench observed that the data furnished by the State Government did not reflect a clear picture in regard to availability of ‘Remdesivir’to the needy patients, as the same had been done on the basis of ‘functional bed capacity’ of each of the hospitals. Expressing displeasure on the effectiveness of such allocation, the Bench directed the State to file an affidavit indicating whether it would cater to the actual need of the patients. The Bench clarified it to the government,

“Our concern would be solely that no patient who is in actual need of the drug in the course of his treatment is deprived of the availability of such drug. It may also happen that such drug being allocated on the basis of ‘functional capacity’ may result into allocation in a hospital wherein there is no real time requirement of the said drug.”

Noticing that the numbers of active patients are reduced almost by two lakhs, the Bench opined that proportionately the Oxygen requirement also ought to have reduced. Hence, the State government was directed to place on record the correct position in regard to the availability of Oxygen.

With regard to the extra legal supply of the medicine/drug Remdesivir at the hands of political and film personalities, the Bench directed the central as well as the state government to submit their records as to how such drug, which is in such short supply, is available to these personalities for distribution to public at large. The Bench further asked reports on whether Remdesivir as supplied by these personalities would suffice the medical test of being non-spurious and genuine. Commenting on a recent trend of submitting “brief notes” in compliances of Court’s order, the Bench expressed its displeasure over such practices and said, “the compliances should be placed on record by way of affidavits. Henceforth we do not permit and continue this practice of submitting ‘brief notes’.”

In regard to the issue of the dashboard indicating the correct figures of availability of beds, the Bench urged the Municipal Corporations concerned and the State Government to have expert opinion of all the stakeholders so that the dashboard reflects the correct picture. The Court suggested the authorities to get inputs of the Air Traffic Controller/Civil Aviation Department and the Railways for correct reflection of the data, information and technology used by them for preparation of up-to-date dashboards. The Bench opined that such facility should not only meet urgent requirement during the pandemic, but it should be available throughout for times to come in regard to all kinds of ailments requiring hospitalization. Hence, the Union of India, State Government, Municipal Corporations and all other authorities were directed to deliberate on such issues and make an endeavor to prepare an ideal dashboard.

[Sneha Nirav Marjadi v. State of Maharashtra, 2021 SCC OnLine Bom 734, order dated 19-05-2021]


Kamini Sharma, Editorial Assistant has put this report together 

Appearance before the Court by:

Counsels for the Petitioner: Simil Purohit a/w Arshil Shah, Nirav Marjadi, Dharmapal
Dave, Parisha Shah, Pariket Shah, Vishal Raman, Smita
Durve and Drasti Jani
Counsels for the State:  Akshay Shinde, B Panel Council with Addl. G.P. Geeta Shastri
For Municiple Council of Greater Mumbai: A.Y. Sakhare with Rohan Mirpury and K. H.
Mastakar
Counsels for UOI: ASG Anil C. Singh a/w Aditya Thakkar with D. P. Singh, Yash Momaya i/b  Gul Asnani
Counsel for Pune Municipal Corporation: Abhijit Kulkarni

Counsel for the Intervener: Nitin P. Deshpande

Patna High Court
Case BriefsHigh Courts

Patna High Court: Noticing alarming contradictions in death records filed by state authorities and cremation records of the crematorium, the Division Bench of Sanjay Karol, CJ., and S. Kumar, J., warned the State authorities to verify all facts before placing it before the Court lest it will amount to filing of false/incomplete affidavit. Comparing the crematorium records with government affidavit, the Bench said,

“Now, this document evidently contradicts the affidavit of the Chief Secretary, Government of Bihar in which the number of deaths reported since 01-03-2021 in District-Buxar is only 6.”

As per the detailed report submitted by the DM, total 81 dead bodies were found flowing in River Ganges. The postmortem of all the dead bodies was conducted and DNA profiling carried out. After following the due procedure, last rites of all the dead bodies were performed. Evidently, some of the dead bodies were found to be in a mutilated condition. As per the deponent, the dead bodies had “come from Uttar Pradesh due to the upstream of river Ganga.”

The State submitted that all remedial measures has already been taken for avoiding pollution in the river Ganges and as such “Mahajal was put on the Boarder of U.P. and Bihar on 10.05.2021.” This fact stands taken with the authorities in the State of Uttar Pradesh. On the direction of the Court, the Commissioner had elaborately dealt with the issue of dead bodies found flowing in River Ganges at Buxar. On the perusal of the affidavit of the Commissioner, the Bench found out a very disturbing picture revealing from 05-05-2021 to 14-05-2021 about 789 persons were cremated only at one cremation ground, i.e. Muktidham Charitarban, Buxar. The Bench remarked that, the affidavit of the commission had evidently contradict the affidavit filed by the State in which the number of deaths reported since 1st March, 2021 in District-Buxar is only 6. In Bihar, District Buxar has a huge population of 17 lakhs persons. The Bench expressed concerns that,

If in ten days only in one crematorium 789 persons were cremated then what would be the position in the entire District and that too of persons belonging to all faith.

Noticing that it was not clear from both the affidavits as to whether the deaths occurred/persons cremated were suffering from Covid-19, the Bench directed the authorities to determine to determine the same and further ascertain the age group of these persons. The Bench warned the State that all facts must be verified from all sources and then only placed before the Bench else it will be considered a false/incomplete affidavit.

Observing that the records of death and births had not been updated on the dedicated government website, the Bench said, “we see no reason as to why the deaths, be it 6 or 789, would not have been updated on the official website.

Lastly, directions were issued to the State to depute at least two technically qualified persons having proficiency in computers with the AG for updating and collecting the data.

[Shivani Kaushik v. Union of India, Civil Writ Jurisdiction Case No. 353 of 2021, order dated 13-05-2021]


Kamini Sharma, Editorial Assistant has put this report together 

Advocates before the Court:

For the Petitioner/s: Shivani Kaushik (In Person)

For the UOI: Dr K.N. Singh (ASG)

For the State: Anjani Kumar, AAG-4

For the Respondent 5: Mrs Binita Singh

For Respondent 6: Shivender Kishore,

For PMC: Prasoon Sinha

For DMCH : Mr. Bindhyachal Rai, Advocate
For GMC : Mr. Rabindra Kr. Priyadarshi ,
For the Intervener : Mr. Rajiv Kumar Singh, Advocate

Case BriefsHigh Courts

Jharkhand High Court: Taking into consideration the reason of urgency i.e., acute surge in Covid-19 pandemic from which people are suffering and dire need of Oxygen, the Division Bench of Ravi Ranjan, C.J., and Sujit Narayan Prasad, J., directed to release Oxygen cylinders which were lying in judicial custody in connection with various cases.

The AG, Mr. Rajiv Ranjan, had preferred this interlocutory application in which urgency had been shown for passing appropriate order for utilization of Oxygen cylinders which are lying in judicial custody in different districts in connection with various cases for the purpose of using those Oxygen cylinders to the persons who are suffering from Covid-19 pandemic and who are in need of Oxygen. The AG had urged that such Oxygen cylinders may be directed to be released in favour of concerned District Health Committee and once the situation will be normalized or there will no need of such Oxygen cylinders, the same will be returned to the concerned police station.

Opining that Oxygen cylinders are of prime importance in saving life of persons suffering from Covid-19 pandemic and that number of such Oxygen cylinders are lying in judicial custody in connection with various cases and if it would be released after imposing appropriate condition, no prejudice would be caused to the parties to the lis rather it will be more beneficial for the people at large, who are suffering from Covid-19 pandemic and further the State Government will be in better position in facilitating the treatment of persons who are suffering from Covid-19 pandemic and are in dire need of Oxygen, the Bench ordered to release the Oxygen cylinder(s) without prejudicing the right of the parties on following conditions:

  1. The District Health Committee of concerned district shall furnish an affidavit with an undertaking before the concerned court for release of such Oxygen cylinder(s).
  2. The undertaking shall contain all details of cylinder viz. quantity of oxygen or its weight etc. and further with specific undertaking that such cylinder would be returned within a period of three months or even earlier if it will be required by the Court.
  3. The Courts, where cases are pending shall pass necessary order by recording such undertaking furnished by the District Health Committee.
  4. The District Health Committee was further directed to ensure identification of such cylinders before release and further secure return of such Cylinder on “as is where is” basis.

Further, it was also directed that the Deputy Commissioner-cum of the District Health Committee concerned shall with consultation of Civil Surgeon of the respective district ensure efficacy of such cylinder(s) and only after testing its perfection it may be used in order to avoid any casualty.

Additionally, taking note of media report regarding precarious condition of Sadar Hospital and death of five patients there due to interruption in supply of Oxygen, the Bench stated,

It is very unfortunate that in the Sadar Hospital at Ranchi, as reported that five patients, who were suffering from Covid-19, have died due to interruption in supply of oxygen

Accordingly, the State was directed to conduct a detailed enquiry on the issue and fix accountability upon the erring person(s) and submit its report. Further, the AG was directed to apprise the Court by filing affidavit with respect to the arrangement made in the Sadar Hospitals of each and every district of the State as also the arrangement made at Medical College, Dhanbad, containing therein the details of beds supported with Oxygen, number of the doctors and para-medical staffs as also the position of oxygen in the said hospitals.

[Suo Motu v. State of Jharkhand, 2021 SCC OnLine Jhar 368, order dated 08-05-2021]


Kamini Sharma, Editorial Assistant has put this report together 

Appearance before the Court by:

For the Petitioner: Rajendra Krishna, Advocate

For the State: Rajiv Ranjan, AG and Sachin Kumar, AAG-II

For the U.O.I.: Rajiv Sinha, A.S.G.I.

Experts CornerMurali Neelakantan

Following Justice Bhat and Dr Swaminathan was always going to be tough but it is even more daunting given that I am on a panel with doctors.

I am delighted to be here but I suspect that I have been the beneficiary of some nepotism having been a student here at NLSIU many, many years ago.

What you will hear over the next 15 minutes was not what I had prepared last week or two weeks ago. Dr Milind Antani casually remarked yesterday that a keynote address is expected to address the topic from 30,000 ft. I therefore have mixed feelings about my debut keynote address.

Now that I have set the expectations low, I will turn to the topic of clinical trials in India and specifically the New Drugs and Clinical Trial Rules, 2019 (‘New CT Rules’).

 

It is not that India did not have clinical trial rules before 2019. There was a whole schedule in the Drugs Rules and clinical trials were conducted in India. Several clinical research outsourcing organisations (sounds like BPO and you would not be wrong in thinking of them in that way), including global ones were active in India with thousands of applications for trials.

 

But in 2012, to quote Bob Dylan, “too many people had died”. In 2013, the Supreme Court[1] put a hold on 162 clinical trials[2]. At the same time, the Parliamentary Standing Committee scrutinised the working of the drug regulator and its report was scathing in its criticism of how drugs had been approved in India[3].

 

The Government, as expected, set up a committee, the Ranjit Roy Chaudhury Committee, to revise the clinical trial rules. The Committee consulted extensively and the current rules were a result of that process.

 

The New CT Rules incorporate the World Medical Association Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects, 1964 as amended in 2013 (Helsinki Declaration)[4]. The two fundamental ideas underpinning the declaration, as I see it, were science and ethics.

 

There was an acknowledgement that decisions will be taken on the basis of science. Clinical trials are essentially scientific studies and the results will be evidence and facts. The New CT Rules lay out a logical and methodical procedure, as one would expect from science. These rules assume that everyone in the ecosystem making a decision will be led by science, evidence and facts. Science, evidence and facts are universal, are not they? So all is well, isn’t it? Well, those of you who have been studying jurisprudence will find this exercise interesting – Did the new rules change the behaviour and culture of the drug regulator tasked with implementing the rules, of the sponsors of the clinical trials or of the doctors conducting the trials? Dinesh Thakur will be addressing the role of the regulator in greater detail but “lipstick on a pig” should bookmark the idea in your head until he speaks and expands on Dr Swaminathan’s thought of the cycle of panic and neglect.

 

There was a recognition in the Helsinki Declaration that progress in medical science required clinical trials but also that these ought to be conducted in an ethical manner. At the heart of this was the relationship between doctor and patient, not a scientist and a specimen, not a lab technician and a Guinea pig.

 

There have been three noble professions – priests, doctors and lawyers. Do not take my word for it – look at the law. These three professions traditionally enjoy privilege. So, what is said to a priest in confession, to a doctor or a lawyer is secret. Perhaps there is a need to have a safe place, a safe relationship to keep some unpleasant truths from society.

 

I know some smart alec is itching to ask why spouses enjoy privilege and what is noble about marriage. After almost 20 years, I am ashamed to say that I do not know.

 

I think of noble professions as requiring a higher standard of ethics and integrity than the wider society to which we belong. The sorry saga of clinical trials in India can be attributed to doctors failing in their duties to their patients. Those who participate in clinical trials are referred to as “volunteers” and their doctors are referred to as “investigators”. That should give you a hint of what is to come and what the consequences are.

 

Patients are often desperate and vulnerable, and rely entirely on the doctor for advice, especially in India. They believe that the doctor is acting in their best interest at all times. This is what the Helsinki Declaration expects. Patients trust doctors like they trust God. But, as Richard Feynman, the Nobel prize winning physicist said, “Religion is a culture of faith; science is a culture of doubt.” Sadly, the less said about the ethics and integrity of babajis and godmen the better and doctors seem to be giving babajis a run for their money these days. I will not say anything about lawyers for fear that it may incriminate me.

 

Since the New CT Rules implement the Helsinki Declaration, is it just a matter of ensuring compliance by key players? Well, yes, but as you will hear during the panel discussion, there are deficiencies.

 

The most significant is the morality of denying access to the knowledge that was obtained in the clinical trials. This knowledge should be shared and Principle 36 of the Helsinki Declaration mandates it – especially since volunteers risk their lives believing that their participation would help mankind, and science progresses best when knowledge is shared. Sadly, the data obtained in the trial is treated as a commercial secret. Justice Bhat alluded to this issue – the regime for data exclusivity is immoral and inhuman and should find no place in civilised society.  A consequence of data exclusivity is that many mistakes will be made and many lives have been and will be lost – all of which are completely avoidable. If only the clinical trial data was shared, subsequent trials would be safer. We will not be killing people while figuring out how they died while, all that time, someone else already knew but just would not tell us.

 

You will hear from other panellists how the pandemic has tested the “system”. I am reminded of a popular saying in shipping towns – “A ship in port is safe, but that is not what ships are built for; in calm waters every ship has a good captain.”

 

Sadly, you are all familiar with fabiflu, remdesivir, plasma, itolizumab, tocilizumab, ivermectin, coronil, Ayush-64…. It does n’ot give me any pleasure to tell you that you are most certainly not immune from the consequences of the New CT Rules.

 

Those of you on Twitter will know me by my handle – @grumpeoldman. You should not have expected an uplifting keynote address. I hope that at lunchtime all you young people will be scared and angry, hungry for change.  Angry that this is happening around you and scared that it could be, or is, happening to you. I assure that we old people will not be. Ultimately, you will find, … most old people lament. Some quote Shelley.  

 

O world! O life! O time!

On whose last steps I climb,

Trembling at that where I had stood before;

When will return the glory of your prime?

No more—Oh, never more!

Out of the day and night

A joy has taken flight;

Fresh spring, and summer, and winter hoar,

Move my faint heart with grief, but with delight

No more—Oh, never more!

A Lament – P.B. Shelley

 

† by Murali Neelakantan is currently Principal lawyer at Amicus. He is a dual qualified lawyer (India and UK) and among other positions, he was formerly a partner at an international law firm in London, Cipla’s first global general counsel, and Executive Director and Global General Counsel of Glenmark Pharmaceuticals.
This is his keynote speech at XIV NLSIR-SAMVA̅D: Partners Symposium.

[1] Swasthya Adhikar Manch v. Union of India2013 SCC Online SC 900.

[2]<https://www.livemint.com/Politics/hFfKjL9PP51TKf6wEiYDcJ/SC-asks-why-government-approved-162-global-clinical-trials-i.html>.

[3]<http://164.100.47.5/newcommittee/reports/EnglishCommittees/Committee%20on%20Health%20and%20Family%20Welfare/58.pdf>.

[4]<https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/>.

Patna High Court
Case BriefsHigh Courts

Patna High Court: The Division Bench of Sanjay Karol, CJ., and Shivaji Pandey, J., addressed the issue of spiraling rise in Covid-19 cases in the state.

The Bench, while resisting to pass any further order stated that the State of Bihar should give the required details on each and every aspect of the matter, such as, availability of medicines, black-marketing and also availability of oxygen gas cylinders in the rural areas, especially the district hospitals because the migrants are coming and there is a chance that the person in the rural area may get infected.

The Bench directed, the State should ensure that the medicines as well as all infrastructures are made available at the district level also. The State must also ensure early vaccination of the age group 18 to 45 years, as it is large chunk of the population and reportedly, the death rate of that class is very high.

[Shivani Kaushik v. Union of India, Civil Writ Jurisdiction Case No. 353 of 2021, order dated 07-05-2021]


Kamini Sharma, Editorial Assistant has put this report together 

Advocates before the Court:

For the Petitioner/s: Shivani Kaushik (In Person)

For the UOI: Dr K.N. Singh (ASG)

For the State: Anjani Kumar, AAG-4

For the Respondent 5: Mrs Binita Singh

For Respondent 6: Shivender Kishore,

For PMC: Prasoon Sinha

 

Patna High Court
Case BriefsHigh Courts

Patna High Court: The Division Bench comprising of Sanjay Karol, CJ., and S. Kumar, J., opined that it is the settled position of law that the right to health, including access to basic medical infrastructure, is a facet of Article 21 of the Constitution of India, which the State is duty-bound to provide. The Bench stated,

Failure on the part of a government hospital to provide timely medical treatment to a person in need of such treatment results in a violation of his right to life guaranteed under Article 21.

Relying on the decision of Constitution Bench of the Supreme Court in Common Cause (A Registered Society) v. Union of India, (2018) 5 SCC 1, the Bench reiterated that when it comes to interpretation of fundamental rights, the Court has to adopt a liberal, dynamic, extensive and interpretative approach and needless to add the right to life has to be with dignity is a settled principles of law. Reliance was also placed by the Court on the decision of Supreme Court in Union of India v. Mool Chand Kharaiti Ram Trust, (2018) 8 SCC 321,wherein it had been reiterated that the constitutional duty to develop “humanism” as envisaged under Article 51-A(h) applicable to the medical profession.

The counsel for one of the petitioners, Mr. Dinu Kumar informed the Court that the Medical Institutions, specified to deal with Covid-19, are lacking in infrastructure. Illustratively, he mentions that C.T. Scan Machines are either not installed or not fully functional/operational, be it for whatever reason.

Since the onset of the first wave of current Pandemic, the Court had been monitoring the position within the State. The Bench opined that the biggest challenge before the Government is to change the mindset of the people of Bihar and break the myth amongst the local populace that- Bihar Corona ko Khaa Gaya Hai. The various directions issued, policies framed and programmes propagated by the Central Government and the State Government under the provisions of Disaster Management Act, 2005 and Epidemic Diseases Act, 1897, needs to be highlighted, popularised and people need to be sensitised, both in the urban and rural areas by all modes of communications, including electronic and print media. The Bench suggested,

On a personal level Persons engaged in pursuing social beneficially schemes, can be asked to sensitize the general public in adhering the advisories issued, at least of wearing masks; maintaining social distancing; avoiding congregation at public places; and taking all precautions in dealing with the problems arising out of current Pandemic Covid-19.

Noticing that in Bihar, recovery rate improved up to 89.72%, above than the national recovery rate of 77.77 % and the death rate in Bihar was the lowest in the country. The Bench complimented the officials, who have wholeheartedly and dedicatedly devoted themselves to this battle against the corona virus. The Bench opined that as representatives of institutions and pillars of a democracy, it is the collectively responsibility of the Court to ensure that the people get help and are provided with the healthcare they need, especially in these times of great crisis. The Bench added,

None should lose life only on account of lack of adequate medical care. We would also be amiss if, right at the outset, we do not acknowledge the excellent work carried out by our doctors and other medical staff whom we had in previous litigation termed as our Guardian Angles.

In the attending circumstances, when the State is in a state of a medical emergency, for the State itself has imposed lockdown from 06-05-2021, the Bench opined that non-reporting of deaths by the functionaries under the Municipal Act and the Panchayat Act should also entail action for their removal on the ground of non-performance/discharge of their duties. Hence,

The public representatives must engage themselves at the grass-root level, for they are pretty familiar with the geography, demography and topography of their respective jurisdiction. to ensure that all deaths taking place within their respective jurisdictions, are immediately reported and certainly not later than 24 hours.

The Bench emphasized that in case of violation to report the deaths within 24 hrs, the Court would make sure to remove the official responsible for negligence from the service. With regard to the issue of hoarding/black-marketing of the medical equipment, including oxygen cylinder, the Bench directed the state to take necessary actions against the same.

Directions by the Court

In the above backdrop, the Bench issued following directions:

  1. The government hospitals are duty-bound to extend medical assistance for preserving human life. Failure on the part of even private hospitals to provide timely medical treatment to a person in need of such treatment results in a violation of his right to life guaranteed under Article 21.
  2. The public representatives as also the functionaries of the State under the Registration Act, Municipal Act and the Panchayat Act shall take all steps ensuring implementation of the Government policies, including immediate registration of deaths, more so in the rural areas of Bihar.
  3. All deaths must be reported within 24 hours. A true picture is essential for taking effective steps in defeating this pandemic Covid-19.
  4. The State need to shift the focus to the rural areas so as to ensure that none is deprived of the medical health infrastructure in connection with pandemic Covid-19.
  5. Government of India shall favourably consider the request seeking enhancement of the quota of oxygen cylinders and oxygen (LMO) within four days.
  6. Municipal authorities are directed to take steps for proper collection, treatment and disposal of waste generated from COVID patients in home isolation.
  7. The process of procuring C.T. Scan equipment is directed to be expedited.
  8. Government of Bihar shall file a fresh affidavit, furnishing complete information in a format (tabular chart) prepared by all the learned counsel in terms of our direction within next four working days.
  9. Fresh data be furnished to this Court, with respect to RTPCR, positivity rate and death etc., making clear the geographical locations, Urban and Rural designations and also, the number of (a) Covid Care Centres (CCC); (b) Dedicated Covid Health Centres (DCHC); (c) Dedicated Health Centre (DHC) or for that matter the private hospitals in each one of the districts.

[Shivani Kaushik v. Union of India, Civil Writ Jurisdiction Case No. 353 of 2021, order dated 13-05-2021]


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Advocates before the Court:

For the Petitioner/s: Shivani Kaushik (In Person)

For the UOI: Dr K.N. Singh (ASG)

For the State: Anjani Kumar, AAG-4

For the Respondent 5: Mrs Binita Singh

For Respondent 6: Shivender Kishore,

For PMC: Prasoon Sinha

For DMCH : Mr. Bindhyachal Rai, Advocate
For GMC : Mr. Rabindra Kr. Priyadarshi ,
For the Intervener : Mr. Rajiv Kumar Singh, Advocate

Jammu and Kashmir and Ladakh High Court
Case BriefsHigh Courts

Jammu and Kashmir High Court: The Division Bench of Pankaj Mithal, Cj., and Sanjay Dhar, J., had taken suo moto action for initiating this PIL concerning Covid-19 pandemic; as the Union Territory was in the spate of second wave of Covid-19 Pandemic.

Amicus curiae, Mrs Monika Kohli, had expressed anxiety that as lawyers everyday both in Jammu and Srinagar Wings of High Court are getting infected by Covid-19 and they have not been vaccinated, there is threat to their life which needs to be addressed immediately by getting them vaccinated. She had further submitted that the families of the lawyers who have died recently due to Covid-19 may be provided some financial assistance.

Similarly, the issue of short supply of Remdesivir and deficiency of doctors and nursing staff as well as the oxygen to treat the Covid patients had been highlighted before the Court. In some writ petitions, the petitioners had insisted that the government be called upon to provide complete statistics in regard to the above items and to make operational the oxygen plants which are under erection for some time. The petitioners had also highlighted the shortage of ventilators.

The directions were also sought with regard to supply oxygen cylinders for use by the patients who are not admitted in the hospitals but are otherwise suffering from serious ailments and are home quarantined. And that some mechanism should be evolved so that supply of oxygen to the persons who are getting treatment at home of their serious ailments or those who have been home quarantined due to non-availability of beds in hospitals, may continue uninterrupted.

The Advocate General, Sh. D.C.Raina had submitted on behalf of government that there is no problem of supply of oxygen and there is no ban on use of oxygen for patients at home. They can have the supply of oxygen on medical prescription through Nodal officers. Regarding vaccination of lawyers, it was submitted that there is no difficulty in getting the lawyers above 45 years of age, registered and vaccinated in a group. But the lawyers between the age group of 18 to 45, as per the procedure provided by the government of India, have to get themselves registered online. Once they are registered, they will be vaccinated as per their turn or on the slot available.

The Court remarked that it is conscious of the fact that government is taking due steps for controlling the pandemic and to provide full medical support. However, still much more is required to be done and directions of the Court are primarily needed in respect of registration and vaccination of lawyers, supply of oxygen to patients at home, deficiency of ventilators, oxygen, beds and medication including remedisivir; and doctors, if any.

Insofar as the registration and vaccination of lawyers above the age of 45 years is concerned, the Bench directed the Registry of the Court to discuss the issue with the Finance Commissioner, Health and Medical Education to get some date fixed for the registration and vaccination and to carry out vaccination in groups either at some suitable place in the High Court Campus or Medical College or Hospital within a week. With regard to vaccination of lawyers between the age group of 18 to 45 they were advised to get themselves registered for vaccination and the government was directed to provide them vaccination facilities on priority at the earliest, if possible within a period of two weeks from the date of registration. The Bench said,

In case any family of the lawyer is in need of financial assistance either on account of medical expenditure or due to the death, the family members may approach the Bar Association with an application.

On the application being forwarded, the Court would speedily consider it and endeavor to provide maximum financial aid out of the welfare fund. At the same time, government is also directed to consider for making some additional budgetary allocation, as the funds available may not be sufficient to meet the requirement.

To resolve difficulty faced in the supply of oxygen to the patients at home, the Financial Commissioner, Health and Medical Education is directed to nominate adequate number of Nodal Officers for each city and to publicise their full details with contact number etc so that such patients or their relatives may approach them with proper medical prescription for the supply of oxygen and once they are so approached they shall take immediate and adequate steps to ensure the supply of oxygen where it is found to be needed without causing any harassment to anyone.

Lastly, the Bench stated, we hope and trust that no one would make any effort to draw any mileage out of it so as to reduce it to a personal interest litigation or a publicity interest litigation and the media would also act cautiously in the best interest of the public and country.

[Court on its own motion v. Government of India, 2021 SCC OnLine J&K 334, decided on 05-05-2021]


Kamini Sharma, Editorial Assistant has put this report together 

Appearance before the Court by:

Counsels for the Petitioners: Sunil Sethi, U.K.Jalali, K.S.Johal, Abhinav Sharma, Pranav Kohli, Rohit Kapoor and Ajay Bakshi

For Government of India: AG D.C.Raina Dy.  AG K.D.S. Kotwal

Case BriefsHigh Courts

Bombay High Court: The Division Bench of M.S. Sonak and Nitin W. Sambre, JJ. observed that the two DMs of Goa had carved out exceptions in the order of the Court regarding non-entry in Goa without Covid negative certificate. The Bench stated, the magistrates are bound by Courts order and they cannot modify the same on their own.

On 06-05-2021, the Court had issued an interim Order to the State Administration to ensure that no persons are permitted entry into the State unless they possess a negativity certificate obtained within 72 hours from the time they seek entry into the State. It was made clear that until this interim order is modified a negativity certificate will be a must for entry into the State of Goa.

Despite the aforesaid, the District Magistrates had carved out an exception for persons entering in Goa for a medical emergency on production of proof or coming in an ambulance. Similarly another District Magistrates had issued orders covering several aspects, including inter alia the aspect of entry of persons into the State of Goa. Clause 2(c) of these orders reads as follows:

2. The following activities will be prohibited: (a) …….. (b) …….. (c) Inter-State movement for tourists from 10th May onwards (people who are residents of Goa or are entering Goa for work, or who have with them the full vaccination certificate or Covid negative test report for a test done a maximum of 72 hours prior to entering in Goa will be permitted). (d) ………

Noticing that despite its clear and unambiguous Order, the two District Magistrates either on their own or otherwise, had proceeded to carve out exceptions in favor of residents of Goa entering into the State; the Bench said,

The District Magistrates were bound by our Order and could not have by themselves or otherwise modified our order or refused to comply with our orders.

However, the Bench made an exception to its earlier order in respect of persons entering in Goa for medical emergency on production of proof or those who are coming in an ambulance. The Court directed the District Magistrates liberty to amend their impugned orders. On the submission of Advocate General that the impugned orders will be amended by evening, the Bench stated, “irrespective of whether such amends are made or not from the midnight intervening 11th and 12th May 2021, the State Administration shall ensure that no person who does not possess a Covid negativity certificate based on a test done a maximum 72 hours before seeking entry into Goa, will be permitted to enter into Goa.

The only exception shall be for persons entering in Goa for medical emergency on production of proof or those who are coming in an ambulance.

Consequently, the State Administration was directed to ensure the compliance.

[South Goa Advocates Assn. v. State of Goa,2021 SCC OnLine Bom 695 , decided on 11-05-2021]

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Appearance before the Court by:

For the Petitioners: Adv. Nikhil Pai

For the State of Goa: AG D.J. Pangam with Adv. Ankita Kamat,
For the Union of India: ASG P. Faldessai and SC R. Chodankar,

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Bom HC| “Not a case of sealing the borders”; HC tells State to ensure person entering in Goa carry a Covid-19 “negative” certificate

Case BriefsHigh Courts

Tripura High Court: The Division Bench of Akil Kureshi, CJ., and S. Talapatra, J., activated a public interest petition which was initiated suo moto by the High Court last year when the so-called first wave of corona virus was swiping the whole country and also affecting the State of Tripura. For a while it appeared that the corona virus had subsided. However, by way of abundant caution, this public interest petition was kept alive, not realizing that unfortunately, the situation may arise where further hearing of this PIL would be necessary.

While fortunately the second wave of Covid 19 was somewhat delayed in Tripura compared to the other states of the country, the administration had a longer notice and therefore more time to prepare to meet with the challenges. The Court requested the administration to provide further data and make a few constructive suggestions such as the number of testing each day. The Court emphasized on the importance of wearing masks at all public places, to ramp up testing followed by isolation of those who might have recently been in contact with the corona positive patients and lastly, to vaccinate as quickly and as widespread a population as possible in order to control the overall spread of corona virus.

The Court as a precautionary measure requested the State administration to provide an affidavit on the next day of hearing i.e 17-05-2021 with the following mentioned data:

  • Whether there is any scientific model available with the State Government on the basis of which with reasonable accuracy the peak number of corona positive cases per day can be predicted.
  • If so, on the basis of this model it is possible to project the peak requirement of hospital beds with a break up of those required with oxygen and without oxygen.
  • The availability of total number of such beds with and without oxygen supply.
  • What could be the maximum oxygen demand in terms of units/quantity at the peak of the spread of virus and what is the availability of the oxygen with the State administration. The source of continuous supply of such oxygen will also be disclosed.
  • The availability of remdesivir dozes and other life saving drugs including steroids which may be required in emergency for extreme cases of corona infection. The availability of equipments for treating serious cases of corona virus shall also be stated.
  • Whether the hospitals in the State have any special arrangements for pediatric corona patients and whether any such specialized dedicated ward or arrangement is necessary or would be required in coming days.
  • In the affidavit, the deponent has provided the data about the persons already vaccinated for the first time and also second time. The affidavit also states that the State Government has decided to vaccinate the entire population above the age of 18 free of cost.

The Court stated that affidavit shall state the percentage of those who qualify for vaccination have already been vaccinated first time and second time as also when shall the persons above the age of 18 but below the age of 45 shall have excess to vaccination and rough timelines within which the State administration expects to cover substantial portion of the population which is eligible for such vaccination. The affidavit shall also state exact dozes of vaccination currently available with the State administration and further expected availability from time to time.

For Court on own motion: Mr Somik Deb, Amicus Curiae. For Respondent(s) : Mr S.S. Dey, Advocate General. Mr Debalay Bhattacharjee, GA. Ms Ayantika Chakraborty, Advocate.

[Court on its own motion v. State, 2021 SCC OnLine Tri 265, decided on 10-05-2021]


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