New Delhi / Mumbai: India’s drug regulator is set to ask state drug control departments to withdraw approvals for 3,000 brands of so-called “combination drugs”, which generate nearly Rs4,000 crore in annual revenues for dozens of drug companies but whose efficacy and safety are in question.
The move comes after years of discussions and deliberations over the pending proposal. The drugs in question are manufactured and marketed by almost all of India’s leading drug makers.
FACING THE AXE (Graphic)
The move to pull the drugs from the market is on the ground that they were not approved by the central authority, because of which no regulatory formalities to prove their safety and efficacy were conducted, as is the requirement for all new drug approvals.
The Central Drugs Standard Control Organisation, the central authority that approves new drugs for marketing in the country, will soon send notices to all state drug control departments asking them to withdraw licences for manufacturing these combination drugs.
The office of the Drug Controller General of India (DGCI) has prepared a list of 282 such drug combinations, known in the industry as fixed-dose combinations. These combinations, made by combining one key drug with one or more other drugs, are available throughout the country in hundreds of drug brands.
The fixed-dose combinations are made under the pretext of combining different drugs, which are already approved in India individually, into a single pill or capsule for treating multiple indications (diseases) in patients.
“Though these drugs are individually approved here, a combined formulation has to be treated as a new drug and the safety and efficacy tests have to be conducted again to clear them for marketing. This is not done when the licences are sought from the state departments,” M. Venkateswarlu, DGCI, told Mint.
“We have already sensitized the issue in the Drug Consultative Committee, an advisory board to the central drug department that comprises of senior regulatory officials, drug experts and the state drug controllers,” he said. “A list of these drug combinations has also been circulated to the state drug commissioners for their immediate attention.”
According to a senior member in the drug consultative committee who did not want to be identified, the list circulated to the states by the central department includes 37 brands sold by Cipla Ltd and Alkem Laboratories Ltd, 36 brands of Nicholas Piramal India Ltd, 21 of the antibiotics leader Lupin Ltd, 12 brands of the Mumbai-based Sun Pharmaceuticals Industries Ltd and Wockardt Ltd, 15 brands of the country’s largest drug maker Ranbaxy Laboratories Ltd and 30 brands of Ahmedabad-based Cadila Healthcare Ltd.