Last Updated on July 24, 2023 by The Health Master
FDCs Ban case
The Division Bench of the Delhi High Court, presided over by Chief Justice Satish Chandra Sharma and Justice Sanjeev Narula, has recently been hearing petitions by pharmaceutical manufacturers against the Central government’s order prohibiting 14 fixed dose combinations (FDCs).
In a recent development, the Court has granted a two-week extension to the Centre to submit counter-affidavits in all the matters, while the pharmaceutical companies have been given a week’s time to file their affidavits regarding their existing stock.
This article delves into the specifics of the case and the background leading up to this decision.
Pharmaceutical Companies Seek Relief from FDCs Ban
When the matter came up for hearing on July 17, the counsel for the Union of India, Vidhi Jain, requested additional time to file counter-affidavits in response to the petitions filed by pharmaceutical companies.
The petitioners’ counsel argued that they received the counter-affidavits on July 15, and in some cases, just a day before the hearing.
Some companies approached the Court after the hearing was already scheduled for July 17, creating a need for urgent consideration of their cases.
Court Grants Time for Submission of Counter-Affidavits
Acknowledging the complexity of the case and the need for sufficient time to respond, the Division Bench allowed the Union of India’s counsel two weeks to file the counter-affidavits in all the pending matters.
However, the Bench also reminded some of the petitioners that they had not yet complied with the interim order by submitting an affidavit concerning their existing stock.
As a result, these companies were granted an additional week to file the necessary affidavits as directed by the Court.
Interim Orders to Continue
The Court emphasized that the interim orders issued in connection with the petitions would remain in force until further notice.
This meant that any restrictions or directives already given would continue to apply during the course of the proceedings.
The Court scheduled the next hearing for August 28, 2023, giving both parties sufficient time to prepare their submissions.
Number of Companies Approaching the Delhi High Court Increases
The FDCs ban has stirred significant concern among pharmaceutical companies, leading to a growing number of cases being filed with the Delhi High Court.
As of now, 40 companies have approached the Court seeking relief from the ban.
Previous Proceedings and Coordinate Bench Order
Before the recent hearing, on July 3, the Delhi High Court considered writ petitions filed by 28 pharmaceutical companies, including major players in the market.
The Court granted ten days to the Government of India and the nation’s drug regulator to submit their counter-affidavits in response to these petitions.
The Court had also previously directed that the order passed by a Coordinate Bench in a similar matter involving Lupin Ltd and another on June 28, 2023, would apply “mutatis mutandis” to the drugs subject to the current writ petitions.
The legal term “mutatis mutandis” implies that the order would apply to other cases with necessary changes, while the main points would remain the same.
Coordinate Bench Order on June 28, 2023
The Coordinate Bench’s order on June 28, 2023, based on a petition from Lupin Ltd and another, provided specific directions regarding the distribution and manufacture of the banned drugs.
According to the order:
- Drugs already in the distribution channel would not be withdrawn.
- No fresh manufacture of the banned drugs would be allowed until the next date of hearing.
- No coercive action would be taken against the petitioner for drugs already in the distribution channel.
- The direction against coercive action applies to stocks manufactured on or before June 2, 2023.
- The distribution channel includes all persons, such as stockists, wholesalers, and retailers, with the drugs present after leaving the petitioner’s premises.
Requirement to Submit Details of Existing Stock
The Court further sought details of the stock of each company’s respective drugs as of the date of hearing before the next scheduled date.
Additionally, the companies were required to provide an affidavit regarding the stock currently in circulation.
Background of the FDCs Ban
The ban on 14 FDCs, including cough syrups, anti-allergy drugs, and pain relief medicines, was initiated by the Centre through a Gazette of India notification in June 2023.
The ban was implemented based on recommendations from an expert committee, which indicated potential risks to human beings from these drugs.
The committee’s report, submitted on April 1, 2022, was also approved by the Drugs Technical Advisory Board (DTAB).
The prohibition was enacted under Section 26A of the Drugs and Cosmetics Act, 1940, which grants powers to the Central Government to regulate or restrict the manufacture and distribution of drugs in the interest of public health and safety.
Challenges to the FDCs Ban
Some of the companies filing petitions with the Delhi High Court argued that their products had been available in the market for several decades.
They contended that the government’s notification only vaguely mentioned potential risks to human beings without providing specific reasons or extent of these risks.
Conclusion
The Delhi High Court’s recent decision to grant time for the Centre and pharmaceutical companies to submit counter-affidavits has implications for the ongoing ban on 14 fixed dose combinations.
As the matter proceeds, it remains to be seen how the Court will weigh the arguments presented by both parties and arrive at a final decision that considers public health and the interests of the pharmaceutical industry.
The scheduled hearing on August 28, 2023, will be a crucial event in this ongoing legal battle.
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