Health ministry bans 156 FDCs with immediate effect

The Union ministry of health and family welfare (MoHFW) has banned 156 fixed dose combinations including common cold, fever, antibacterial and antifungal medicines with immediate effect, stating that they are irrational combinations and use of these drugs is likely to involve risk to human beings whereas safer alternatives are available.
 
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.
 
The FDCs banned include single products with combinations of 12 to 15 drugs. At least 22 formulations out of the 156 banned are having the component Naphazoline, a decongestant which is used to relieve red eye or puffy eye due to various ailments.
 
The drug combinations banned now include several products manufactured by drug majors including Sun Pharmaceuticals, Dr Reddy's Laboratories, Cipla, Alkem Laboratories, Mankind Pharma, Torrent Pharmaceuticals, Eris Lifesciences, among others, according to information available.
 
It may be noted that the Centre has in the middle of last year banned 14 FDCs licensed prior to 1988, including several cough syrups, anti allergy drugs and pain relief drugs, with immediate effect, following advice from an expert committee that these drugs may involve risk to human beings. More than 40 drug companies including many of the major players in the industry approached the High Courts seeking to quash the ban.
 
The Central government has been working on examining various irrational FDCs and banning many combinations for their apprehended risk to the users. It has banned 344 combinations through an order in March 10, 2016, based on the recommendations of the Professor Kokate Committee, in public interest as use of these FDCs were mentioned as likely to involve risk to human beings when safer alternatives are available.
 
The Committee was appointed by the centre following the 59th report of the Department-related Parliamentary Standing Committee on Health and Family Welfare observed that some state licensing authorities had issued manufacturing license for several FDCs without prior clearance from the Central Drugs Standard Control Organisation (CDSCO) and that this had resulted in availability of many FDCs in the market which have not been tested for efficacy and safety putting patients at risk.
 
Several stakeholders approached various High Courts against the notification and the Delhi High Court quashed the notification on December 1, 2016. The Central government appealed the Supreme Court of India and the apex court, in a judgement on December 15, 2017, recommended that the case of 349 FDCs banned by the Centre, except for the 15 FDCs that are pre-1988 approved and 17 FDCs which have DCGI approval, to be referred to the Drugs Technical Advisory Board (DTAB) for further examination.
 
The DTAB appointed a sub committee headed by Nilima Kshirsagar to look into the FDCs and pharma majors Abbott Healthcare and Laboratories Griffon approached the Supreme Court pointing out that the 15 FDCs approved prior to September 21, 1988 were never meant to be referred to the sub-committee.