Decision based on expert committee recommendations; government says unsafe FDCs to be removed from the market
New Delhi/Hyderabad, July 25: The Central Government has prohibited the manufacture, sale and distribution of 16 Fixed-Dose Combination (FDC) drugs, citing concerns that these medicines pose a risk to public health. The decision was announced in Parliament on Friday, following recommendations from the Drugs Technical Advisory Board (DTAB) and an expert committee constituted in 2021.
According to the government, the ban follows a detailed scientific review of the safety, efficacy and therapeutic justification of these combination medicines. The expert panels concluded that the identified FDCs lack sufficient evidence of clinical benefit and may expose patients to unnecessary health risks.
Fixed-Dose Combination (FDC) medicines contain two or more active pharmaceutical ingredients combined into a single dosage form. While many FDCs are widely used and clinically beneficial, health authorities have repeatedly raised concerns over irrational combinations that may increase the risk of adverse drug reactions, inappropriate dosing, antimicrobial resistance or unnecessary exposure to multiple medicines.
The Centre informed Parliament that the decision was taken after considering the final report of the DTAB sub-committee and the recommendations of the expert committee formed in 2021 to evaluate the safety and efficacy of such drug combinations.
With the notification coming into effect, the manufacture, sale and distribution of the 16 identified FDCs will no longer be permitted in India. Regulatory authorities are expected to ensure compliance, while pharmaceutical companies will be required to withdraw the affected products from the market.
The move is part of the government’s ongoing efforts to strengthen drug regulation and ensure that only safe, effective and scientifically validated medicines remain available to patients. In recent years, the Centre has taken similar action against several irrational FDCs after expert reviews found them to have an unfavourable risk-benefit profile.
Health experts advise patients currently using combination medicines not to discontinue prescribed treatment abruptly. Instead, they should consult their treating physician or pharmacist to determine whether their medication is among the banned products and discuss suitable alternatives if necessary.