Delhi HC Directs Petitioners To File Joint Written Submission On FDC Ban Issue

New Delhi: The Division Bench of Delhi High Court, which is hearing the petitions by pharmaceutical manufacturers against the Central government’s order prohibiting 14 fixed dose combinations (FDCs), has directed the petitioner firms and organisations to file a joint written submission in advance before the next hearing.

The Bench, comprising Acting Chief Justice Manmohan and Justice Manmeet Pritam Singh Arora, said that the interim orders issued earlier in connection with the petitions are to continue. The matter is now listed for hearing on September 9.

When the matter came up for hearing on May 13, the Court directed all the petitioners to file a joint written submission not exceeding ten pages at least a week prior to the next date of hearing. A total of 93 petitions from more than 40 companies are heard together by the division bench.

The Court, while hearing a petition from Lupin Ltd, on June 28, 2023 directed that the drugs which are already in the distribution channel shall not be withdrawn, but no fresh manufacturing should take place till next hearing.

“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 interim 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. The order has been made applicable in respect of the drugs which are subject matter of the other writ petitions which are of the same nature.

The companies approached the Court after the Central government issued several orders through the Gazette of India in the beginning of June, 2023 banning around 14 fixed dose combinations, 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.  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.

Companies including Dr Reddy’s Laboratories, Abbott Healthcare, Cipla, Lupin, Alkem Laboratories, Mankind Pharma, Intas Pharmaceuticals, Seagull Laboratories, Laborate Pharmaceuticals, Laboratories Griffon Pvt Ltd, Shreya Life Sciences, Obsurge Ltd, Leeford Healthcare, CCI Products, JD Pharma, Venus Labs, Skymap Pharmaceuticals, and an organisation Indian Federation of Pharma Generics among others approached the Delhi High Court against the notification.

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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