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The Division Bench of the Delhi High Court has issued an interim order in relief to around 16 companies who approached the Court against the Centre's recent notifications banning 156 fixed dose combinations (FDCs) stating them as irrational combinations.
The Centre has prohibited 156 FDCs including common cold, fever, antibacterial and antifungal drugs with immediate effect through separate notifications issued on August 2, 2024.
The High Court order on September 2 was on petitions filed by Cipla, Zydus Healthcare, Mankind Pharma, Alkem Laboratories, Intas Pharmaceuticals, Bharat Serums and Vaccines, Entod Pharmaceuticals, Leeford Healthcare, Mankind Prime Labs, Laborate Pharmaceuticals, Khandelwal Laboratories, Indchemie Health Specialities, DWD Pharmaceuticals, Pharm Products Pvt Ltd, Centaur Pharmaceuticals, and Jenburkt Pharmaceuticals after they were prohibited to manufacture for sale, distribute for human use of the FDCs with immediate effect.
Petitions were filed by these companies on around 40 notifications banning one FDC each, all dated August 2, and published online in the official Gazette on August 21, 2024.
It may be noted that on August 29, the Division Bench has issued similar orders in petitions filed by six companies, Mankind Pharma, Indoco Remedies, Leeford Healthcare, Obsurge Biotech, Navil Laboratories, and Vilco Laboratories challenging seven notifications.
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 the drug should take place till further hearing. It also ordered that no coercive steps will be taken against the petitioner for the drugs which are already in the distribution channel.
Considering the petitions filed by the companies against the August 2 notifications, 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 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," said the Bench in its order on September 2.
The Union of India has been granted four week's time to file a counter affidavit. The matter is now listed for hearing on December 10, 2024.
In June, 2023, the government banned 14 FDCs licensed prior to the year 1988, including cough syrups, anti allergy drugs and pain relief medicines with immediate effect following advice from an expert committee that these drugs may involve risk to human beings.
More than 40 companies approached the Delhi High Court following this, many of them alleging that the notification under dispute only states that the FDC may involve risk in human beings without specifying the reasons/extent and the nature. In addition, the FDC has been in the market marked since 1988.
The Ministry, in separate orders issued on August 2, 2024, for each FDC, has said that the decision has been taken after the matter was examined by an expert committee appointed by the Central government and the Committee considered these FDCs as irrational.
The Drugs Technical Advisory Board (DTAB) has also examined the FDCs and recommended that "there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under Section 26A of Drugs and Cosmetics Act, 1990."
The Ministry also quoted the DTAB recommending as, "In view of above, any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under Section 26A is recommended".
Section 26A provides powers to the Central government to regulate or restrict, manufacture etc. of drugs in public interest, by notification in the Official Gazette.
On the basis of the recommendation of the DTAB, "the Central government is satisfied that it is necessary and expedient in public interest to prohibit the manufacture for sale, sale and distribution for human use of the said drug in the country", it added.
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