Health Ministry Bans 156 Fixed Dose Combinations

The ban includes commonly used medications for cold, fever, and antibacterial and antifungal treatments.

The Union Ministry of Health and Family Welfare (MoHFW) has banned 156 fixed dose combinations (FDCs) with immediate effect. 

The ban includes commonly used medications for cold, fever, and antibacterial and antifungal treatments. The ministry cited these combinations as "irrational" and noted that safer alternatives are available.

Days back, the MoHFW issued separate orders prohibiting each of the 156 FDCs. This decision followed an evaluation by an expert committee appointed by the Central government, which deemed these FDCs irrational. 

The Drugs Technical Advisory Board (DTAB) also reviewed the FDCs and concluded 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 DTAB's recommendation included the assertion that "any kind of regulation or restriction to allow for any use in patients is not justifiable. Therefore, only prohibition under Section 26A is recommended."

Reasoning Behind the Ban

The banned FDCs include products combining 12 to 15 drugs. Notably, 22 of these formulations contain Naphazoline, a decongestant used for alleviating red or puffy eyes. 

The ban affects products from major pharmaceutical companies such as Sun Pharmaceuticals, Dr Reddy's Laboratories, Cipla, Alkem Laboratories, Mankind Pharma, Torrent Pharmaceuticals, and Eris Lifesciences.

The Ministry's move follows a previous ban in mid-2023, which prohibited 14 FDCs licensed before 1988. 

This earlier ban included cough syrups, anti-allergy drugs, and pain relief medications deemed risky. Numerous pharmaceutical companies challenged this decision in the High Courts.

Context & Challenges

The Central government has a history of regulating FDCs to ensure safety. On March 10, 2016, the government banned 344 FDCs based on the Professor Kokate Committee’s recommendations. 

This ban addressed FDCs deemed to involve risks to human health, with safer alternatives available.

The Department-related Parliamentary Standing Committee on Health and Family Welfare had earlier reported that some state licensing authorities issued manufacturing licenses for various FDCs without prior clearance from the Central Drugs Standard Control Organisation (CDSCO). 

This led to the availability of many FDCs in the market that had not been tested for efficacy and safety.

In response to the 2016 ban, several stakeholders approached the High Courts, and the Delhi High Court quashed the notification on December 1, 2016. 

The Supreme Court of India subsequently appealed, which, on December 15, 2017, recommended referring the case of 349 banned FDCs, except for 15 pre-1988 approved FDCs and 17 FDCs with DCGI approval, to the DTAB for further examination.

The DTAB appointed a sub-committee led by Nilima Kshirsagar to review the FDCs. 

However, pharma majors Abbott Healthcare and Laboratories Griffon contested that the 15 FDCs approved before September 21, 1988, should not have been reviewed by the sub-committee.