The Ministry of Health and Family Welfare has banned around 156 fixed-dose combination (FDC) drugs. Medicines such as Cheston Cold and Foracet, used for cold, fever, and pain, including others that could pose a significant threat to human lives, were banned with immediate effect.
Reports say the ban is a sweeping crackdown on FDCs—combinations of two or more known drugs in single-dosage form—since 2018 when 328 such drugs were banned. Officials said a total of 499 FDCs have been banned since 2014.
In a recent notification, the central government termed these FDCs irrational and said they do not have any therapeutic benefit. This decision was made following recommendations from an expert committee and the Drugs Technical Advisory Board (DTAB), which both deemed these FDCs to lack therapeutic justification and identified them as potential risks to public health.
According to Business Today, this ban represents a broader attempt to regulate the pharmaceutical industry, following actions such as the prohibition of 344 combination drugs in March 2014, and 16, more were discovered in June 2023.
Reports also suggest that many of the products on the recent banned list have already been discontinued by several manufacturers. The impact of this ban is expected to be nominal for big players in the pharmaceutical manufacturing industries, who have shifted focus towards safer and rational drug combinations. Smaller companies, however, might feel under the ropes as they have limited resources to adapt to the regulatory changes.
