New Delhi: Days after the Centre through a notification prohibited at least 156 fixed dose combinations (FDC) drugs stating them as irrational combinations, a Division Bench of the Delhi High Court has issued an interim order against such notification giving relief to several companies who had approached the court.
The High Court order is in connection with petitions moved by six companies including Mankind Pharma, Indoco Remedies, Leeford Healthcare, Obsurge Biotech, Navil Laboratories, and Vilco Laboratories challenging Government of India’s notifications, where the companies were prohibited to manufacture for sale, distribution for human use of the FDCs with immediate effect.
Significantly, the petitioners drew the attention of the Bench to an order issued in June 28, 2023, in a matter related to the Ministry of Health’s earlier notifications banning 14 FDCs, which granted interim protection for the drugs already in the distribution network while directing companies that no fresh manufacturing of drugs should take place till further hearing.
The earlier order also stated that no coercive steps will be taken against the petitioner for the drugs which are already in the distribution channel.
Considering the fresh petitions filed by the companies against the August 2 notification, the Division Bench comprising Acting Chief Justice Manmohan and Justice Tushar Rao Gedela, ordered that in order to maintain parity, the interim order issued on June 28, 2023, shall apply in respect of the drugs which are subject matter of the present writ petitions.
The court in its order, a copy of which is in possession of ETV Bharat, also said that the petitioners shall file details of the stock of their respective drugs as on today, if not filed earlier, within three days from today.
“They shall also give an affidavit of stock in circulation, within three days,” the Bench said in an order issued on August 29, 2024.
The court has also granted four-week time to the Union of India to file a counter affidavit. The matter is now listed for hearing on December 10, 2024.
Earlier on Thursday, the pharmaceutical companies approached the Delhi High Court seeking interim relief against the Central government’s decision to ban 156 fixed drug combinations (FDCs) medicines, so that they could clear the stocks lying in the market.
The FDCs drug is a combination of two or more active pharmaceutical ingredients (APIs) in a single form. The government has termed the use of these FDCs as irrational, noting that they do not have any therapeutic benefit and banned these 156 drugs under section 26A of the Drugs and Cosmetics Act, 1940.
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