Last Updated on September 8, 2023 by The Health Master
Ban on Cough Syrup
This matter is scheduled to be the foremost topic of discussion when the court addresses the prohibition of 14 fixed-dose combinations (FDC) through orders set for June 2, 2023.
In this legal development, we delve into the details of the court’s ruling, the parties involved, and the implications for pharmaceutical companies.
1. Court’s Decision and Bench Composition:
- The Division Bench of the Delhi High Court, consisting of Chief Justice Satish Chandra Sharma and Justice Sanjeev Narula, issued an order on August 28, 2023.
- The court has allocated a week for the Union of India’s legal counsel to respond to cases filed by various companies against the government’s notifications.
2. Legal Opposition by Pharmaceutical Companies:
- Over 50 companies have taken legal action against the Union government and the Drugs Controller General (India) in response to the notifications.
- Kirtiman Singh, representing the Union of India, requested that matters related to Notification No. S.O. 2398 (E) dated June 2, 2023, be given precedence during the hearings, a request not opposed by the opposing parties.
3. Upcoming Hearing Date and Continuation of Interim Orders:
- The court has scheduled the matter for a hearing on September 22.
- The interim orders related to this issue will remain in effect until further notice.
4. Impact on Pharmaceutical Brands:
- The Ascoril-C syrup, Glenmark Pharmaceuticals’ Ascoril-C syrup, Glencoff-C syrup, and Ascodex-C syrup, among other well-known brands, may be impacted by the ban.
5. Background and Justification for the Ban:
- On June 2, 2023, the Union Government issued a series of notifications, including notification No. S.O. 2398 (E) dated June 2, 2023, which prohibits the manufacture, sale, and distribution of chlorpheniramine maleate + codeine syrup for human use.
- This action was based on the recommendation of an expert committee, which found no therapeutic justification for the ingredients in this fixed-dose combination (FDC) and potential risks to human health.
- The decision was also influenced by recommendations from the Drug Technical Advisory Board (DTAB)
6. Legal Precedents and Application of Mutatis Mutandis:
- Various pharmaceutical companies approached different High Courts to challenge the ban.
- The Delhi High Court directed that the order passed by a Coordinate Bench in Lupin Ltd. and another vs. Union of India and another, on June 28, 2023, shall apply mutatis mutandis to the drugs subject to these writ petitions.
- Mutatis mutandis means that the order will apply to other cases with necessary changes, while maintaining the core principles.
7. Interim Orders on Distribution:
- The interim order from June 28, 2023, stipulated that drugs already in distribution channels should not be withdrawn.
- Fresh manufacturing of the banned drug would be halted until the next hearing date.
- No coercive measures would be taken against the petitioners for drugs in the distribution channel.
- This direction applies to stocks manufactured on or before June 2, 2023, and covers all individuals in the distribution network, such as stockists, wholesalers, and retailers.
8. Court’s Request for Inventory Information:
- The court has requested that petitioners provide details of their respective drug stocks as of the hearing date and submit an affidavit detailing the circulation of their products.
The Delhi High Court‘s decision to prioritize the hearing on the ban on cough syrup (chlorpheniramine maleate + codeine syrup) marks a significant development in the ongoing legal battle between pharmaceutical companies and the Union government.
This decision, along with the continuation of interim orders, has far-reaching implications for the pharmaceutical industry, necessitating a close watch on the upcoming proceedings.
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