More firms join litigation against Central govt on FDC ban

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At least seven more pharma companies and a federation of pharma manufacturers have approached the Delhi High Court against the Central Government’s order in the beginning of June prohibiting manufacturing, distribution and sale of 14 fixed dose combinations (FDCs) licensed prior to the year 1988.

It may be noted that when the Court took up the matter for hearing on July 3, writ petitions filed by 28 pharmaceutical companies including some of the major players in the market were considered and the Court granted ten days’ time to the Government of India and the nation’s drug regulator to file a counter affidavit on these petitions.

After this, petitions were filed by Indian Federation of Pharma Generics and companies including Karnani Pharmaceuticals, DWD Pharmaceuticals, Vinayak Remedies Ltd, Acron Pharmaceuticals, Biogenetic Drugs, American Vitamins India, and Astra Labs.

These petitions, along with the petitions filed earlier, have been directed to be listed for further proceedings on July 17, 2023.

The division bench comprising Chief Justice Satish Chandra Sharma and Justice Sanjeev Narula, directed in separate petitions filed by these companies that the order passed by a Coordinate Bench in Lupin Ltd and another vs Union of India and another in a similar matter on June 28, 2023 shall apply mutatis mutandis in respect of the drugs which are subject matter of these writ petitions. The legal term mutandis, according to experts, means that the order will apply to the other cases with necessary changes, but with the main points remaining the same.

The Order on June 28, 2023 based on a petition from Lupin Ltd and another, directed that the drugs which are already in the distribution channel shall not be withdrawn.

“However, no fresh manufacture of the drug will take place till the next date of hearing. In addition, no coercive steps will be taken against the petitioner for the drugs which are already in the distribution channel,” said the Order. It also clarified that the direction against taking of coercive action would apply with respect to stocks manufactured on or before June 2, 2023 and that the distribution channel would cover all persons including stockists, wholesalers, retailers etc., with whom the stocks or the drug in question may be present after they have left the premises of the petitioner.

The Court also sought the petitioners to file details of the stock of their respective drugs as on the date of hearing before the next date of hearing and also give an affidavit of stock in circulation, within one week from the date of order.

The Union of India and the drug regulator were granted ten day’s time to file a counter affidavit.

The order issued by the Centre through the Gazette of India in the beginning of June, 2023 said that the combinations, including cough syrups, anti allergy drugs and pain relief medicines are banned with immediate effect following advice from an expert committee that these drugs may involve risk to human beings. The export committee report, furnished to the Government on April 1, 2022 was also agreed by the Drugs Technical Advisory Board (DTAB), it added.

The prohibition was invoking the Section 26A of the Drugs and Cosmetics Act, 1940, which provides powers to the Central Government to regulate or restrict, manufacture etc. of drugs in public interest, by notification in the Official Gazette.

“And whereas, on the basis of the recommendations of the Expert Committee and the Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to regulate by way of prohibition the manufacture for sale, sale and distribution for human use of the said drug in the country,” said the separate notifications issued on the 14 FDCs, by the Ministry on June 2, 2023.

Some of the companies while filing the petition with the High Court argued that their products were available in the market for several decades and the notification by the government only stated that the FDC may involve risk in human beings without specifying the reasons or extent and the nature.

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