Emcure Pharma became one of the first pharma companies to apply for and get some interim relief from the union health ministry’s recent prohibition of the sale and distribution of fixed dose combinations (“FDC”). Emcure had filed a writ petition before the Delhi High Court seeking the quashing of the August 12, 2024 notification, which prohibited the manufacture for sale and distribution of the company’s pain relief FDC of S (+)-Etodolac + paracetamol for human use with immediate effect. Emcure’s senior counsel stated before the Delhi High Court that the report of the sub-committee, on the basis of which the ban has been notified, has not been made public till date. The senior counsel also stated that it remains unclear why complete prohibition of the subject matter FDC has been recommended.
The court order shows that Emcure’s senior counsel drew the attention of the Delhi High Court to an order dated July 3, 2023, regarding FDCs (Phenytoin + Phenobarbitone Sodium of Lupin) which had been prohibited under similar circumstances. The petition also referred to previous orders dated June 14, 2023, of the same court, which had under similar circumstances, granted interim protection for the drugs already in the distribution network. The June 2023 order specified that while drugs already in the distribution channel shall not be withdrawn, no fresh manufacture of the drug could take place till the next date of hearing. In addition, the order stated that no coercive steps would be taken against the petitioner for the drugs which are already in the distribution channel.
The Delhi HC order dated August 22, 2024, directed that the interim order of June 14, 2023, shall apply to Emcure’s drugs which are part of the present writ petitions. The court also directed Emcure to file details of the stock of these banned FDCs as of the order date, within a week. The company also needs to give an affidavit of stock in circulation, within a week. The Union of India was granted four weeks’ time to file a counter affidavit. Rejoinder affidavit, if any, needs to be filed before the next date of hearing, which has been listed as January 15, 2025.
The scene seems set for a repeat of previous prohibitions on FDCs, starting from 2016 with 344 FDCs prohibited. After a stay was granted, the matter was referred back to the Drugs Technical Advisory Board (DTAB), which stood by their decision on 328 drugs. The union ministry accepted their recommendation and banned these 328 FDCs in 2018. The next lot of banned FDCs in 2023 too saw similar litigation from several companies.
Pharma associations have gone on record to welcome the recent notification, with Sudarshan Jain, Secretary General, Indian Pharmaceutical Alliance pointing out that the discussion on FDCs is going on over a period of time with recommendations from the Kokate committee and Nilima Kshirsagar committee. He feels this is the right step in the interest of patients and all aspects have been taken into consideration.
Industry associations are planning to file appeals along similar lines of the Emcure petition, to allow companies to exhaust stocks in the distribution network as well as stocks already manufactured that may be still within company premises. A future plan of action includes associations supporting their members should they contest the notification’s premise that their FDCs are purportedly irrational combinations. If companies feel strongly that these are good products, have been in the market for over 30-40 years, and see no reason for a ban, associations will help them make their case.
While it remains to be seen whether more pharma companies challenge the notification, the recent ban revives the discussion on why such purportedly irrational combinations were approved in the first place. Industry discussion groups allude to cases where state licensing authorities took the stance that since individual molecules were licensed, it was fine to pass a combination of licensed molecules.
The gazette notification for each individual banned FDC stated, “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 26 A of the Drugs and Cosmetics Act 1940. In view of the 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.” The sentence, ‘The FDC may involve risk to human beings’ without specifying the reasons/extent and nature, puts the onus on the government to prove that a particular FDC is harmful to patients’ health.
Going a step back, should not the authorities have examined whether there were therapeutic benefits of FDCs when licences were applied for? Similarly, should they have not examined whether there is no risk to patients before they grant a manufacturing licence? The list of banned FDCs include medicines for common illnesses like cold, fever, antibacterial and antifungal medicines, as well as antibiotics, anti-allergy medication, painkillers and multivitamins. Medicines in India can be purchased very easily without a prescription, leading to the potential long-term misuse of many such irrational combinations. Given this reality, putting the patient first, before granting licences seems the solution.
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