Legislation Updates

The Ministry of Ayush has notified the Drugs and Cosmetics (Draft Amendment) Rules, 2021 on 23rd September 2021. The draft Rules amend the Drugs and Cosmetics Rules, 1945 by substitution of Rule 30AA. The key points under Rule 30AA are:

  • No New Homoeopathic medicine shall be imported without the permission in writing by the Licensing Authority.
  • The importer of a New Homoeopathic medicine when applying for permission shall produce before the Licensing Authority such documentary and other evidence as may be required by the Licensing Authority for assessing the safety, therapeutic efficacy of the medicine including the minimum homoeopathic provings carried out with it.
  • The New Homoeopathic Medicine shall continue to be considered as New Homoeopathic Medicine for a period of four years from the date of its first approval.
  • The Licensing Authority after being satisfied that the drug shall be effective and safe for use in the country shall issue approval subject to the conditions stated therein.

 

The Ministry has launched the consultation inviting objections and suggestions from the public which shall be addressed to the Secretary, Ministry of AYUSH, AYUSH Bhawan, ‘B’ Block, GPO Complex, INA, New Delhi – 110023 or emailed at dcc-ayush@nic.in. within 30 days.

 


*Tanvi Singh, Editorial Assistant has reported this brief.

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.

Case BriefsSupreme Court

Supreme Court: Stating that fixing the price of any commodity is not only difficult but also tricky, the Court held that the notification dated 13th July, 1999 issued by the Central Government under Paragraph 7 of the Drugs (Prices Control) Order, 1995 prescribing the norms for conversion cost, packing charges and process loss of raw materials (other than packing materials in conversion) and packing and process loss of packing materials in packaging is valid as it was issued after due application of mind.

The Bench of Madan B. Lokur and R.K. Agrawal, JJ said that there is material to be considered, a bundle of factors to be considered and appropriate weight is to be given to the material and the factors. This is not easy to decide and there will always be some criticism with regard to either the material utilized or the factors considered or the weight attached to the materials and factors. In matters pertaining to drug formulations, it is not only an issue of demand and supply but also the ability of a common person to afford the formulation. At the same time, the manufacturer must also make some profit and be in a position to invest in research and development. There simply cannot be any mathematical precision in fixing the price of a commodity.

The Court said that it is true, as contended by Cipla, that no manufacturer/formulator is under an obligation to furnish whatever information is required by the Central Government including information that might be confidential but that does not mean that absolutely no information should be supplied by any company or incomplete information should be supplied by a very few of them. It would certainly be more appropriate for each company to have responded to the questionnaires sent with a communication that some particular information is not being furnished for reasons of confidentiality. The Court noticed that given the non-cooperative attitude of the drug industry, the Central Government prescribed the norms and Cipla and the drug industry were obliged to accept them as notified without much ado. It cannot be that the drug industry does not supply necessary information and data to the expert Committees appointed by the Central Government and then blames the Central Government for taking a decision without necessary information and data. Noticing that there have been earlier instances of non-cooperation by the drug industry, the Court said that the failure of the drug industry to extend effective cooperation an endemic problem.

The Court also held the notifications issued by the Central Government fixing the retail price or ceiling price of formulations under Paragraphs 8 and 9 (as the case may be) of the Drugs (Prices Control) Order, 1995 without determining the norm for cost of packing material as required by Paragraph 7 of the Drugs (Prices Control) Order, 1995 are valid in law and the fixing of retail price of a formulation under Paragraph 8 of the Drugs (Prices Control) Order, 1995 without first fixing the sale price of a bulk drug under Paragraph 3 of the Drugs (Prices Control) Order, 1995 utilized in the manufacture of a formulation, to be valid in law.

With regard to the manner in which the Union of India has handled the litigation as very little or scanty material was placed by the Union of India before the concerned High Courts, particularly the Allahabad High Court, the Court said that such practice deserves discouragement as it tends to degrade the importance of proceedings in the High Court and could subsequently embarrass the High Court which might inadvertently base its decision on insufficient material resulting in the possibility of an incorrect decision which is liable to be set aside and it might also cause serious prejudice to a litigant.

The Court also said that in matters where public interest is involved, the Court ought to be circumspect in granting any interim relief. The consequence of an interim order might be quite serious to society and consumers and might cause damage to public interest and have a long term impact. [Union of India v. Cipla Ltd., 2016 SCC OnLine SC 1159 , decided on 21.10.2016]

Foreign Legislation

On 03-02-2015, the Central Government published the draft Drugs and Cosmetics (Second Amendment) Rules, 2015 and sought for objections and suggestions from any person with respect to the said draft rules within 45 days from the date of publication of the draft. The objective of the draft Rules is to further amend the Drugs and Cosmetics Rules, 1945 in order to assure that the licensed manufactured drugs are stable for proposed shelf life under the condition of storage. The draft Rules proposes following amendments in the Drugs and Cosmetics Rules, 1945:

  • Insertion of sub-Rule (6A) after sub-Rule 6 in Rule 71, insertion of sub-Rule (2) after Rule 71-B which shall be numbered as sub-Rule (1), insertion of sub-Rule (7A) after sub-Rule 7 in Rule 76, insertion of sub-Rule (2) after Rule 76A which shall be numbered as sub-Rule (1), and all of which provides that “the applicant shall, while applying for licence to manufacture drugs, furnish to the Licensing Authority evidence and data justifying that the drugs are stable for proposed shelf life under the condition of storage recommended and the data shall be generated as per Appendix IX of Schedule Y”.
  • Substitution of following entry “Substances not intended for medicinal use excluding those intended to be used as drugs after further purification or rendering them sterile” in place of “Substances not intended for medicinal use”, in Schedule D, against item number 1, under the column “Class of drugs”.

 

-Ministry of Health and Family Welfare