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Delhi HC grants 10 days’ time to Govt to file counter affidavit on petitions against ban of 14 FDCs

Posted on July 12, 2023 Updated on July 9, 2023

The Delhi High Court has granted ten days’ time to the Government of India and the nation’s drug regulator to file a counter affidavit on the petitions filed by almost 28 pharma companies against the order prohibiting manufacturing, distribution and sale of 14 FDCs licensed prior to the year 1988, in the beginning of June.

The companies approached the court with separate petitions, some with more than one petition for separate products that come under these banned FDCs, in different dates earlier and the Court posted all the matters for hearing on July 3, with a direction that the drugs that are in the distribution channel shall not be withdrawn, no fresh manufacturing of the drug should take place till the next date of hearing and no coercive steps should be taken against the petitioners for the drugs which are already in distribution.

When the matters came up for hearing on July 3, the division bench comprising Chief Justice Satish Chandra Sharma and Justice Sanjeev Narula ordered that in order to maintain parity, the interim-order passed in the matter of Lupin Ltd against Union of India, shall apply in respect of the drugs which are subject matter of the present writ petitions.

It 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 July 3.

“As prayed for, the respondent/Union of India is granted ten days’ time to file a counter-affidavit,” said the Court, fixing the next date of hearing on July 17, 2023.

The companies which approached the Delhi High Court with writ petition against the ban of FDC include Lupin Ltd, Dr Reddy’s Laboratories, Obsurge, Intas Pharmaceuticals, Brukem Lifecare, Khandelwal Laboratories, Eden Healthcare, Alkem Laboratories, Windlas Biotech Ltd, Abbott Healthcare, Leeford Healthcare, Seagull Laboratories, Glenmark Pharmaceuticals, Laborate Pharmaceuticals, Laboratories Griffon, Shreya Life Sciences, Mankind Pharma, Cipla Ltd, CCI Products, JD Pharma, Venus Labs, Skymap Pharmaceuticals, Kepler Healthcare, Horizon Bioceuticals, Aptus Pharma, Jupiter Pharmaceuticals, Ozone Pharmaceuticals Ltd, and Wings Pharmaceuticals. Some of these companies have filed multiple writ petitions, each for separate combinations banned under the order issued in June. Some of the petitions were filed against the Drugs Controller General (India).

According to reports, some other companies have approached other high courts against the ban.

Earlier they argued that the 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 extend and the nature.

The order issued by the Centre through the Gazette of India 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.

The drugs prohibited through the notification include nimesulide+ paracetamol dispersible tablets, amoxicillin+ bromhexine, pholcodine + promethazine, chlorpheniramine maleate + dextromethorphan + guaiphenesin + ammonium chloride + menthol, chlopheniramine maleate + codeine syrup, ammomium chloride + bromhexine + dextromethorphan, bromhexine + dextromethorphan + ammonium chloride + menthol, dextromethorphan + chlorpheniramine + guaiphenesin + ammonium chlorid, paracetamol + bromhexine + phenylephrine + chlorpheniramine + guaiphenesin, salbutamol + bromhexine, salbutamol + bromhexine, phenytoin + phenobarbitone sodium, ammonium chloride + sodium citrate + chlorpheniramine maleate + menthol (100mg + 40mg + 2.5mg + 0.9mg) , (125mg +55mg+4mg+1mg), (110mg+46mg+3mg+0.9mg) and (130mg+55mg+3mg+0.5mg)per 5ml syrup and salbutamol + hydroxyethyltheophylline (Etofylline) + bromhexine.

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