Last Updated on July 27, 2023 by The Health Master
Ban on Pre-1988 FDCs
Several pharmaceutical companies and a federation of pharma manufacturers have challenged the Central Government’s order issued in early June.
The order banned the manufacturing, distribution, and sale of 14 fixed dose combinations (FDCs) that were licensed prior to 1988.
With at least seven additional companies joining the legal battle, the Delhi High Court is set to hear these petitions along with the ones filed earlier on July 17, 2023.
Background:
On July 3, the Delhi High Court considered writ petitions filed by 28 pharmaceutical companies, including prominent players in the market.
The Court granted the Government of India and the nation’s drug regulator ten days to prepare a counter affidavit for these petitions.
Subsequently, the Indian Federation of Pharma Generics and companies as under also filed petitions:
- Karnani Pharmaceuticals,
- DWD Pharmaceuticals,
- Vinayak Remedies Ltd,
- Acron Pharmaceuticals,
- Biogenetic Drugs,
- American Vitamins India,
- Astra Labs.
Court Proceedings and Mutatis Mutandis:
The division bench, consisting of Chief Justice Satish Chandra Sharma and Justice Sanjeev Narula, addressed the separate petitions filed by these companies.
They directed that the order passed by a Coordinate Bench in Lupin Ltd and another vs Union of India and another case on June 28, 2023, would apply mutatis mutandis to the drugs in question.
Mutatis mutandis, a legal term, means that necessary changes will be made to the order, while the main points will remain the same, ensuring its application to other similar cases.
Order of June 28, 2023:
Based on a petition filed by Lupin Ltd and another party, the June 28 order stated that drugs already in the distribution channel should not be withdrawn.
However, the manufacture of these drugs would be temporarily halted until the next date of hearing.
The order also ensured that no coercive action would be taken against the petitioner for drugs already in distribution. This direction applied to stocks manufactured on or before June 2, 2023.
The distribution channel encompassed stockists, wholesalers, retailers, and others in possession of the drug after it left the petitioner’s premises.
Requirements for Petitioners and Counter Affidavit:
The Court asked the petitioners to provide details of their respective drug stocks as of the hearing date before the next hearing.
Additionally, they were required to submit an affidavit of the stock in circulation within one week from the date of the order. The Union of India and the drug regulator were granted ten days to file a counter affidavit.
Government’s Ban and Expert Committee Report:
In early June 2023, the Central Government issued a ban on 14 FDCs, including cough syrups, anti-allergy drugs, and pain relief medicines.
The ban took immediate effect based on advice from an expert committee, which reported potential risks associated with these drugs.
The report was subsequently agreed upon by the Drugs Technical Advisory Board (DTAB).
The ban was implemented under Section 26A of the Drugs and Cosmetics Act, 1940, which empowers the Central Government to regulate or restrict drug manufacture in the interest of public safety.
Contentions of the Petitioners:
Some of the companies filing petitions with the High Court argued that their products had been available in the market for several decades.
They contended that the government’s notification merely stated the possibility of risks to human beings without specifying the reasons, extent, or nature of those risks.
Summary:
The Delhi High Court will continue its proceedings on July 17, 2023, considering the petitions filed by various pharma companies challenging the Central Government’s ban on pre-1988 licensed drug combinations.
The court will weigh the arguments and evidence presented by both sides to determine the future course of action regarding the ban and its potential impact on public health and the pharmaceutical industry.
High Court refuses to stay ban on 14 FDCs: Gujarat
Govt investigates these 3 FDCs for Safety and Efficacy
DTAB upholds prohibition on FDC of Vitamin B1, B6, and B12
Pharma Traders Association request time to withdraw recently banned 14 FDCs
394 Product Permissions of 14 banned FDCs to be cancelled: Gujarat
Govt gives nod to sale of 2 rational FDC drugs
India Pharma Industry is leading market for USFDA Authorizations
USFDA issues Form 483 to Lupin with 2 observations: Nagpur
USFDA issues EIR to Lupin for Pithampur unit-2
USFDA gives nod for Sevelamer HCL tablets
Govt to establish recruitment Rules for Medical Device Officers
DCGI gives approval for Dupilumab to treat Atopic Dermatitis
Stringent action to be taken against companies that make spurious drugs: HM
USP establishes Program Unit Team on testing of Excipients
Major fire breaks out at Govt’s medicine godown: Odisha
Pharma Cleanrooms: Ensuring compliance with GMP
For informative videos by The Health Master, click on the below YouTube icon:
For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos on consumer awareness, click on the below YouTube icon:
