FDCs: Pharma Companies to File Joint Submission in High Court

The Delhi High Court has directed the petitioners to submit a joint written document before the next hearing scheduled for September 9, 2024

The Health Master

May 16, 2024

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Last Updated on May 23, 2024 by The Health Master

High Court

The Delhi High Court has directed pharmaceutical companies challenging the Central government’s ban on 14 fixed dose combinations (FDCs) to file a joint written submission before the next hearing.

This article explores the ongoing legal battle between pharmaceutical companies and the government over the safety of these drugs.

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Government Ban on 14 FDCs

In June 2023, the Indian government, acting on the advice of an expert committee, prohibited the manufacture, sale, and distribution of 14 FDCs.

These combinations, commonly used for cough, allergies, and pain relief, were deemed to pose a potential health risk.

The ban was invoked under Section 26A of the Drugs and Cosmetics Act, 1940, which empowers the government to regulate drugs in the public interest.

Pharmaceutical Companies Challenge the Ban

Over 40 pharmaceutical companies, including Dr. Reddy’s Laboratories, Abbott Healthcare, Cipla, and Lupin, filed petitions in the Delhi High Court against the government’s notification.

They argued that their FDCs had been safely used for decades and questioned the basis for the ban.

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Current Developments in the Case

Joint Written Submission:

The Delhi High Court has directed the petitioners to submit a joint written document outlining their arguments before the next hearing scheduled for September 9, 2024.

This submission is limited to 10 pages and must be filed at least a week prior to the hearing.

Interim Orders Continue:

The court’s previous interim orders remain in effect.

These orders allow the sale of existing FDC stocks in the distribution channel (including stockists, wholesalers, and retailers) but prohibit further manufacturing until the next hearing.

Inventory Disclosure:

The court has also directed the pharmaceutical companies to submit details of their existing FDC stock and provide an affidavit of stock circulation before the next hearing.

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The Road Ahead

The joint written submission by the pharmaceutical companies is expected to provide a comprehensive defense of their FDCs.

The government, on the other hand, will likely present evidence from the expert committee to support the ban.

The Delhi High Court’s decision in this case will have significant implications for the future of FDCs in India.

Key Points:

14 FDCs banned by the Indian government in June 2023 due to safety concerns.
Pharmaceutical companies challenge the ban in Delhi High Court.
Companies to file a joint written submission before the next hearing.
Interim orders allow sale of existing FDC stock but prohibit further manufacturing.
Court decision will impact the future of FDCs in India.

Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.