Why These 16 Drug Combinations Failed India's Safety Review
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Centre prohibits 16 drug combinations nationwide, saying risks outweigh benefits and directing regulators to enforce the ban immediately.
By Pranjal Gupta
New Delhi, June 21: Sixteen commonly used drug combinations will no longer be available in India after the Centre banned their manufacture, sale and distribution, saying they lack scientific justification and could pose risks to public health.
The Ministry of Health and Family Welfare on Saturday issued notifications prohibiting the Fixed Dose Combinations (FDCs) under Section 26A of the Drugs and Cosmetics Act, 1940. The ban has come into effect immediately across the country.
The move follows a Supreme Court-directed review of fixed-dose medicines sold in India. Acting on the court's instructions, the Drugs Technical Advisory Board (DTAB) formed an expert committee to examine whether various drug combinations were safe, effective and medically justified.
After reviewing the available scientific evidence, the committee identified 16 FDCs that it found to be irrational, lacking therapeutic value or carrying risks that outweighed any potential benefits.
According to the Health Ministry, the banned products include medicines from several therapeutic categories, such as dermatological treatments, pain-relief and antispasmodic drugs, as well as certain antibiotic-based formulations.
Officials said the decision forms part of the government's broader effort to ensure that only scientifically validated and safe medicines remain available to patients.
The ministry noted that similar action has been taken in the past against irrational drug
combinations following expert reviews, describing the latest ban as another step towards strengthening patient safety and evidence-based healthcare.
With the notifications now in force, the manufacture, sale, distribution and supply of the 16 identified FDCs for human use have been prohibited nationwide.
State drug controllers and other regulatory authorities have been instructed to ensure strict enforcement of the ban. Manufacturers, importers, distributors and other stakeholders have also been directed to take immediate corrective measures to comply with the new rules.
The government said the action is aimed at protecting patients from medicines whose risks may outweigh their benefits and ensuring greater accountability in the pharmaceutical sector.
