Amendments to existing lawsLegislation Updates

National Commission for Indian System of Medicine Bill, 2020 received Presidential Assent on 20-09-2020.

The National Commission for Indian System of Medicine Act, 2020.

Purpose of the Act:

Act to provide for a medical education system that improves access to quality and affordable medical education, ensures availability of adequate and high quality medical professionals of Indian System of Medicine in all parts of the country

Encourages such medical professionals to adopt latest medical research in their work and to contribute to research; that has an objective periodic and transparent assessment of medical institutions and facilitates maintenance of a medical register of Indian System of Medicine for India and enforces high ethical standards in all aspects of medical services; that is flexible to adapt to the changing needs and has an effective grievance redressal mechanism.

Key Highlights

Constitution of National Commission for Indian System of Medicine [SECTION 3] 

Central Government will constitute the National Commission for Indian System of Medicine. The said commisison shall be a Corporate Body with it’s head office at New Delhi.

Composition of Commission [SECTION 4]

Persons of the Commission will be as follows:

(a) Chairperson;

(b) fifteen ex officio Members; and

(c) twenty-three part-time Members.

The said Section also elaborates the qualification and experience required by the said Members and Chairperson.

Search Committee for appointment of Chairperson and Members [SECTION 5]

Central Government shall appoint the Chairperson, referred to in Section 4 and the President of the Autonomous Boards referred to in Section 20 on the recommendation of a Search Committee.

Term of office and conditions of service of Chairperson and Members [SECTION 6] 

Chairperson and Members (other than ex officio Members) and Members appointed under Secton 4 shall hold office for a term not exceeding 4 years and shall not be eligible for any extension or re-appointment.

Removal of Chairperson and Members of Commission [SECTION 7]

When can Central Government remove the Chirperson or any Member?

  • Adjudged as Insolvent
  • Convicted of an offence which involves moral turpitude
  • Physically or Mentally incapable of acting as the Chairperson or a Member
  • Unsound Mind
  • Has acquired such financial or other interest and is likely to affect prejudicially his function as a Member
  • Has abused his poisition as to render his continuance in office prejudicial to public interest

Power and Functions of Commission [SECTION 10]

Following functions shall be performed by the Commission:

(a) lay down policies for maintaining a high quality and high standards in

education of Indian System of Medicine and make necessary regulations in this behalf;

(b) lay down policies for regulating medical institutions, medical researches and medical professionals and make necessary regulations in this behalf;

(c) assess the requirements in healthcare, including human resources for health and healthcare infrastructure and develop a road map for meeting such requirements;

(d) frame guidelines and lay down policies by making such regulations as may be necessary for the proper functioning of the Commission, the Autonomous Boards and the State Medical Councils of Indian System of Medicine;

(e) ensure coordination among the Autonomous Boards;

(f) take such measures, as may be necessary, to ensure compliance by the State Medical Councils of Indian System of Medicine of the guidelines framed and regulations made under this Act for their effective functioning under this Act;

(g) exercise appellate jurisdiction with respect to decisions of the Autonomous Boards;

(h) ensure observance of professional ethics in Medical profession and to promote ethical conduct during the provision of care by medical practitioners;

(i) frame guidelines for determination of fees and all other charges in respect of fifty per cent. of seats in private medical institutions and deemed to be Universities which are governed under the provisions of this Act;

(j) exercise such other powers and perform such other functions as may be prescribed

Advisory Council [Sections 11 to 13]

Advisory Council shall be the primary platform through which the State and Union Territories may put forth their views and concerns before the Commission.

NATIONAL EXAMINATION [Sections 14 to 16]

National Eligibility-cum-Entrance Test [SECTION 14]

A unifrom National Eligibility-cum-Entrance Test for admission to the undergraduate courses in each of the disciplines of the Indian System of Medicine in all medical institutions governed by this Act shall be conducted.

National Exit Test for Undergraduates [SECTION 15]

To grant license as a medical parctitioner to the undergraduate final year students, a common national exit test shall be held.

National Entrance Test for Post-Graduates [SECTION 16]

A uniform Post-Graduate National Entrance Test shall be conducted separately for admission to postgraduate courses in each discipline of the Indian System of Medicine.

Postgraduates |National Teachers ’ Eligibility Test for Indian System of Medicine [SECTION 17]

A National Teachers’ Eligibility Test shall be conducted separately for the postgraduates of each discipline of Indian System of Medicine who desire to take up teaching profession in that discipline.

Constitution of Autonomous Boards [SECTION 18]

Central Government shall constitute the follwoing Autonomous Boards which shall be under the overall supervision of the Commission:

(a) the Board of Ayurveda;

(b) the Board of Unani, Siddha and Sowa-Rigpa;

(c) the Medical Assessment and Rating Board for Indian System of Medicine; and

(d) the Board of Ethics and Registration for Indian System of Medicine.

Powers and Function of Autonomous Boards [SECTION 26]

(a) determine the standards of education at the undergraduate, postgraduate and super-speciality levels

(b) develop a competency based dynamic curriculum at all levels, in such manner that it develops appropriate skill, knowledge, attitude, values and ethics among the postgraduate and super-speciality students and enables them to provide healthcare, to impart medical education and to conduct medical research;

(c) frame guidelines on setting up of medical institutions for imparting undergraduate, postgraduate and super-speciality courses in Ayurveda, Unani, Siddha and Sowa-Rigpa;

(d) determine minimum requirements and standards for conducting of courses and examinations in medical institutions, having regard to the needs of creativity at local levels and the regulations made under this Act;

(e) determine standards and norms for infrastructure, faculty and quality of education and research in medical institutions of Indian System of Medicine, in accordance with the regulations made under this Act;

(f) specify norms for compulsory annual disclosure, electronically or otherwise, by medical institutions of Indian System of Medicine in respect of their functions that has a bearing on the interest of various stakeholders including students, faculty, the Commission and the Government;

(g) facilitate development and training of faculty members;

(h) facilitate research programmes;

(i) grant recognition to medical qualifications at all levels.

Powers and functions of Board of Ethics and Registration for Indian System of Medicine have been laid down under Section 27 & Powers and functions of Medical Assessment and Rating Board for Indian System of Medicine have been laid down under Section 28.

State Medical Council [SECTION 31]

State Government within 3 years of the commencement of the Act shall establish a State Medical Council for Indian System of Medicine in that State.

The said Council shall be responsible to take disciplinary actions in respect of any professional or ethical meisconduct by a resgistered practitioner of India System of Medicine.

National Register and State Register of Indian System of Medicine [SECTION 32]

Board of Ethics and Registration for Indian System of Medicine shall maintain a National Register containing the name, address, all recognised qualifications possessed by a licensed medical practitioner of the Indian System of Medicine and such other particulars as may be specified by regulations.

Rights of persons to practice [SECTION 34]

Only the persons who will be registered in either the State Register of the National Register shall:

  • allowed to practice Indian System of Medicine as a qualified practitioner
  • hold office as a physician or surgeon or any other office, by whatever name called, which is meant to be held by a physician or surgeon
  • be entitled to sign or authenticate a medical or fitness certificate or any other certificate required by any law to be signed or authenticated by a duly qualified medical practitioner
  • be entitled to give evidence at any inquest or in any court of law as an expert under Section 45 of the Indian Evidence Act, 1872 on any matter relating to Indian System of Medicine

To read the detailed act, please follow the link: ACT


Ministry of Law and Justice

Case BriefsCOVID 19Supreme Court

Supreme Court: After the Central Government filed an affidavit orders have been issued to comply the directions issued by the Supreme Court on June 19, 2020 in suo motu petition on proper treatment of COVID-19 patients and dignified handling of dead bodies in the hospitals, the bench of Ashok Bhushan, R. Subhash Reddy and MR Shah, JJ said that

“Mere direction to comply the directions is not enough. The steps taken towards compliance of the directions have to be brought on the record.”

The Court also took note of the facts that the State Governments / UTs have not filed affidavits giving details of compliance of various directions issued by it on June 19, 2020. It was, hence, of the view that the Chief Secretaries of the States have to take steps to ensure that directions are complied with and an appropriate compliance report be filed within 2 weeks.

It also directed the Union of India to file detailed affidavit within two weeks giving the details of the various compliance of the directions issued vide order dated June 19, 2020.

The 3-judge bench of Ashok Bhushan, SK Kaul and MR Shah, JJ had, on June 19, 2020, issued detailed directions in the matter relating to deficiencies, shortcomings and lapses in patient care of Covid-19 in different hospitals in National Capital Territory of Delhi and other States where the Court had taken suo motu cognizance on the basis of media reports and programmes aired in several channels presenting horrific scenes from LNJP hospital, which is a COVID-19 dedicated hospital.

[IN RE THE PROPER TREATMENT OF COVID 19 PATIENTS AND DIGNIFIED HANDLING OF DEAD BODIES IN THE HOSPITALS ETC, 2020 SCC OnLine SC 604, Order dated 27.07.2020]


Read the detailed report on the directions issued on June 19, 2020 here.


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Case BriefsCOVID 19Supreme Court

Supreme Court: The 3-judge bench of Ashok Bhushan, SK Kaul and MR Shah, JJ has issued detailed directions in the matter relating to deficiencies, shortcomings and lapses in patient care of Covid-19 in different hospitals in National Capital Territory of Delhi and other States where the Court had taken suo motu cognizance on the basis of media reports and programmes aired in several channels presenting horrific scenes from LNJP hospital, which is a COVID-19 dedicated hospital.

The Court had, on June 12, 2020, issued notice to all States and Union Territories seeking Status report with regard to Government hospitals, patient care and the details of the staff, infrastructure, etc.

On the affidavit filed by Delhi Government, the Court noticed that in the entire affidavit, apart from general statement that all steps are being taken, the affidavit does not indicate any mechanism for proper supervision of the functioning of the hospital and steps for improvement. The affidavit tries to give an impression to the Court that everything in the Government hospital in NCT, Delhi is well and all steps are being taken by the Government of NCT of Delhi.

“When the Government does not endeavour to know any shortcomings or lapses in its hospitals and patient care, the chances of remedial action and improvement becomes dim.”

The Court further, said that the necessary guidelines on all aspects of patients’ care, hospital management, testing, infrastructure are in place as has been highlighted by Union of India in its affidavit. However, the main concern is the faithful and strict implementation of the said guidelines which can be only ensured by constant supervision, monitoring and taking remedial steps with regard to improvement of infrastructure, staff, facilities, etc.

DIRECTIONS ISSUED

On reasonable rates for COVID related facilities/test etc

  • Centre should issue appropriate guidelines/directions to all the States/Union Territories with regard to prescribing reasonable rates of various COVID related facilities/test etc., which need to be uniformly followed by all concerned. In case, with regard to any particular State/Union Territory, there is any difference, the same may be specifically noticed and directed accordingly.

On continuous supervision and monitoring of government hospitals, Covid dedicated hospitals and other hospitals taking care of covid management

  • The Ministry of Health and Family Welfare, Union of India, shall constitute Expert Committees consisting of

a) Senior Doctors from Central Government hospitals in Delhi,

b) Doctors from GNCTD hospitals or other hospitals of Delhi Government,

c) Doctors from All India Institute of Medical Sciences, d) Responsible officer from Ministry of Health and Family Welfare.

  • The Expert Committee shall inspect, supervise and issue necessary directions to all Government hospitals, Covid hospitals and other hospitals in NCT of Delhi taking care of Covid patients. The Expert Committees shall ensure that at least one visit in each hospital be done weekly.
  • The above team may in addition to normal inspection shall also conduct surprise visits to assess the preparedness of the hospitals. The expert team as indicated above after visiting may issue necessary instructions for improvement to the hospital concerned and also forward its report to the Government of NCT of Delhi and the Union of India, Ministry of Health and Family Welfare.
  • States shall also constitute an expert team of Doctors and other experts for inspection, supervision and guidance of Government hospitals and other hospitals dedicated to Covid-19 in each State who may inspect, supervise the hospitals in the State and issue necessary directions for the improvement to the concerned hospital and report to the Government. Chief Secretary of each State shall ensure that such Committees are immediately constituted and start their 8 works within a period of seven days.

On transparency in patient care

  • Footage from the CCTV Cameras shall be made available by the hospitals in NCT of Delhi to the inspecting/supervising expert team or to any other authority or body as per directions of the Union of India, Ministry of Health and Family Welfare for screening the footage and issuing necessary directions thereon.
  • The Chief Secretaries of all States shall take steps regarding installation of CCTV Cameras in COVID dedicated hospitals where COVID patients are taking treatment to facilitate the management of such patients and for the screening of the footage by designated authorities or bodies so that remedial action may be suggested and ensured.

On permitting attendant for COVID-19 Patient

  • All COVID-dedicated hospitals shall permit one willing attendant of the patient in the hospital premise, who can remain in an area earmarked by the hospital
  • All COVID dedicated hospitals shall create a helpdesk accessible physically as well as by telephone from where well-being of patients admitted in the hospitals can be enquired.

On Discharge Policy

  • The Union of India, Ministry of Home Affairs may issue appropriate directions in exercise of power under Disaster Management Act, 2005 to all States/Union Territories to uniformly follow the revised discharge policy dated 08.05.2020 with regard to discharge of different categories of patients as categorised in the revised discharge policy.

The Court will now take up the matter in the third week of July.

[IN RE THE PROPER TREATMENT OF COVID 19 PATIENTS AND DIGNIFIED HANDLING OF DEAD BODIES IN THE HOSPITALS ETC, 2020 SCC OnLine SC 530 , order dated 19.06.2020]

Case BriefsCOVID 19Supreme Court

Supreme Court: Taking sup motu cognizance on the basis of media reports and programmes aired in several channels presenting horrific scenes from LNJP hospital, which is a COVID-19 dedicated hospital, the 3-judge bench of Ashok Bhushan, SK Kaul and MR Shah, JJ issued notice to all States and Union Terrotiries seeking Status report with regard to Government hospitals, patient care and the details of the staff, infrastructure, etc. on the next date of hearing so that appropriate directions be issued by the Court as found necessary.

“All these facts, which have been brought to the notice of the Court by the media reports, clearly indicate a very sorry state of affairs of the patients of Covid-19 in the Government hospitals in the NCT of Delhi as well as in other States.”

Referring to a program aired on India TV on 10.06.2020, the Court noticed,

“The patients are in the wards and the dead bodies are also in the same wards. Dead bodies are seen also in the lobby and waiting area. The patients were not supplied with any oxygen support or any other support, no saline drips were shown with the beds and there was no one to attend the patients. Patients are crying and there is no one to attend them. This is the condition of the Government Hospital of Delhi which has capacity of 2000 beds.”

The Court also took note of the fact that the Government App itself gives the details of beds occupied in the Government and Private hospitals in Delhi. In the Government hospitals, the number of beds is 5814, out of which 2620 are occupied. It, hence, said,

“The large number of beds in Government COVID Hospital being vacant in a situation where patients suspected of Covid-19 are running from pillar to post to get admission in any hospital tells about the mismanagement and sorry state of Government hospitals in Delhi.”

Coming down heavily of the Government, the Court said that the duty of the State of NCT Delhi does not end in informing the people that it has arranged 5814 beds in Government hospitals and 9535 beds including private hospitals. The State and its officers are also duty bound to ensure that patients are taken care, attended, provided all medical facility, the hospitals have necessary infrastructure and staff.

The Court also took note of the media reports that indicated there is an increase in the number of patients affected by Covid-19 every day in the entire country especially in Delhi, Maharashtra, Tamil Nadu, Chennai and Ahmedabad. The number of patients increasing day by day is 10,000 or more per day.

On the issue of testing gone down in the State of NCT of Delhi, the Court said,

“Non-testing of the patients is not a solution to the problem rather increase in the testing facility is the duty of the State, so that people may come to know about their health status regarding Covid19 and they may take appropriate care and treatment of Covid-19.”

The Court will next hear the matter on 17.06.2020.

[IN RE THE PROPER TREATMENT OF COVID 19 PATIENTS AND DIGNIFIED HANDLING OF DEAD BODIES IN THE HOSPITALS ETC., 2020 SCC OnLine SC 504 , order dated 12.06.2020]

Op EdsOP. ED.

Digital healthcare is the “healthcare of the future”. Like many other markets, India too is at the cusp of a “digital health” revolution. With an estimated market size of 100 billion USD in recent years, one of the fastest-growing industries in India is healthcare. Healthcare in India is a prime candidate for investment, especially through digital interventions, and this trend is already picking up. Over the last couple of decades, developments in information and communication technology have made the most palpable impact on healthcare management all over the world. Newer terms like telemedicine, e-health, telehealth and digital health surfaced to encompass broad concepts like electronic medical records and hospital automation, telemedicine, e-learning in the health sector, e-governance and so forth.[1] The time is ripe for healthcare companies to embrace innovation and emerging trends to successfully steer new-age technologically driven business strategies by capturing consumer interest.

The e-health space has seen a lot of innovative abovementioned terms being developed. Protection of these ideas and inventions becomes essential in this highly competitive market. India’s Intellectual Property Rights (“IPRs”) regime allows for such protection in various forms, notably patents, copyrights, trade marks and designs. In the context of e-health, development is concentrated in the areas of software applications (including mobile applications) and wearable devices.

Patents

Behind every e-health application is the software that runs it, which is essentially a computer program. A computer program “per se” is excluded from patentability under Section 3(k) of the Patents Act, 1970. The Indian Patent Office, however, in its Guidelines for Examination of Computer Related Inventions (“CRIs”), states that while the CRI in itself is not patentable, it is possible for a CRI claimed in conjunction with a novel hardware to be patented, provided it meets the other requirements such as the three-prong test laid down under the guidelines. Patents for software programs have been issued in the past where it involves a hardware component as well. If the technology/software fulfils these requirements, it could file for a patent and receive protection if the same is granted.

A patent may not be granted if the device or program is determined to be “a process for the medicinal or other treatment of human beings and animals” under Section 3(i) of the Patents Act, 1970 (Section 3 deals with what are not considered inventions). However, the patent examiner’s observations in Lalit Mahajan’s patent application[2] distinguished between a device and process, where “a device for detection of antibodies to HIV (Human Immunodeficiency Virus) and p24 antigen of HIV in human serum or plasma” was found to be outside of the scope of Section 3(i).

Copyright

Software would fall under the definition of “computer program” under the Copyright Act, 1957 and according to Section 2(o), a literary work includes computer programs. Hence the literal part i.e. the source code, is protected under copyright law. The copyright, however, extends to the form and substance of the work, and not the idea itself. This would mean that the idea would have to be expressed in some form of medium before it can be protected.

Clinical guidelines and data could be protected under the Copyright Act, if it is expressed in some form of medium. A mere compilation of data without any further effort may not be protected by copyright law. This is derived from the “sweat of the brow” doctrine, where eventhough there may not be any originality in content such as tables or databases, copyright would subsist only when a person undertakes an independent collection of the information. The person is then entitled to have his effort and expense protected.

Design

In terms of e-health, the two major components that would require design protection would be the graphical user interface (“GUI”) of applications and the design of the devices. GUI may be protected under the Designs Act, 2000, more specifically under Article 14-04 of the Designs Rules, 2001, which covers “Screen Displays and Icons”. However, there have been applications by companies for registration of its GUI which were rejected. The reasoning of the authorities has been that a GUI cannot be registered as a design, as screen displays do not constitute an article, which is one of the requirements for design protection. However, some icons and user interfaces have been registered as a design under Article 14-99 (Miscellaneous). A company could, therefore, apply for design protection of its GUI.

The design of various devices could also be protected under the Designs Act. However, “design” under this Act excludes any mode or principle of construction, or anything which is in substance a mere mechanical device. The design of the device can thus be protected provided it does not fall within the exceptions under the Designs Act.

Trade Mark

The “mark” of an e-health application or device could be registered as a trade mark under the Trade Marks Act, 1999, subject to certain exclusion criteria that form grounds for refusal of the trade mark, such as being devoid of distinctive character or marks or indications which have become customary in the current language or established practice of trade.[3]

Conclusion

The e-health market presents a lot of opportunities, but with every opportunity, there are bound to be risks involved. Innovation in this sector is yet to reach a saturation point, with new products frequently being introduced in the market. The legislative framework to protect and regulate such developments will remain one step behind, as it is yet to be seen how the industry will mature. Regardless, regulators have taken note of the restrictions and in many cases, the absence, of the law and are striving to formulate forward-looking policies and legislations.

It is heartening to see that Government of India is committed to implement e-health and the Steering Committee of Planning Commission strongly suggested that all district hospitals and primary health centers and sub-centers be connected with telemedicine, Skype or similar audiovisual media and to encourage mHealth (healthcare through mobile phones) to reach the remote corners of the country.[4] India has started successful programmes to extend the telemedicine services to neighbouring African and Saarc (South Asian Association for Regional Cooperation) countries.[5] There is no doubt that India is very close to catch up with the rest of the developed world in the practice of e-health for all.


*Vaishali Singh is an Assistant Professor of Law, School of Law, University of Petroleum and Energy Studies.

[1]    Sinha V.D.S., Tiwari R.N., Kataria R., Telemedicine in Neurosurgical Emergency: Indian Perspective, Asian J. Neurosurg 2012.

[2]    Patent Application No. 693/KOL/2007 decided on 11-1-2010.

[3]    S. 9 of the Trade Marks Act, 1999.

[4]   Suja Nair Shirodkar; Health Ministry sets up 10 panels with top officials from DCGI office, SLAs to revise D&C Rules, available at <http://www.pharmabiz.com/NewsDetails.aspx-?aid=96214&sid=1>.

[5]    Saarc Telemedicine project in India, available at <http://www.saarctf.org/Countries/India.aspx>


[Image Courtesy: Healthcare IT News]

NewsTreaties/Conventions/International Agreements

The Union Cabinet has approved the signing of a Memorandum of Understanding (MoU) between India and Bahrain on cooperation in the field of Healthcare.

The MoU covers the following areas of cooperation:-

i. Exchange of information including publications and research outcomes;

ii. Exchanging visits by governmental officials, academic staff, scholars, teachers, experts and students;

iii. Participating in workshops and training courses;

iv. Encouraging health and medical research activities at both the private-sector and the academic level; and

v. Any other forms of cooperation as may be mutually decided upon.

A Working Group will be set up to further elaborate the details of cooperation and to oversee the implementation of this MoU.

Ministry of Health and Family Welfare

NewsTreaties/Conventions/International Agreements

India and Morocco have signed a Memorandum of Understanding (MoU) for enhanced cooperation in the health sector. Shri J P Nadda, Union Minister of Health & Family Welfare and Dr. Abdelkader Amara, Ministry of Health, Kingdom of Morocco signed the MoU. Shri Nadda mentioned that both the countries share a strong and rich traditional relationship. He highlighted that India is producer of quality generic medicines and drugs that are exported to more than 200 countries and has a strong and robust public health system monitored through National Health Mission. He suggested that through this framework MoU between two countries, both the countries can work together in identified areas of cooperation as both countries have much to offer to each other in the field of health.

The main areas of cooperation include the following:

  • Non-communicable diseases, including child cardiovascular diseases and cancer;
  • Drug Regulation and Pharmaceutical quality control;
  • Communicable Diseases;
  • Maternal, child and neonatal health;
  • Hospital twinning for exchange of good practices and
  • Training in administration and management of health services and Hospitals

Another MoU was signed between Jawaharlal Institute of Post Graduate Medical Education and Research (JIPMER), Puducherry and Marrakech Mohamed VI University Hospital, Morocco. Under this MoU both the Institutes agreed to collaborate in the field of telemedicine. The focus areas under this MoU will be Tele-Health Care, Health Education, technical support in controlling epidemics and support in rendering second opinion on various complicated cases.

Ministry of Health and Family Welfare