The central government has told the country’s apex drugs controller to regulate the market of fixed-dose combination drugs in India – an issue pending for several months now. The Central Drugs Standard Control Organisation, the office of the Drugs Controller General of India (DCGI), has already started working on this and the ban on these “cocktail drugs” may be announced within a month, ministry officials said.
Fixed-dose combinations (FDCs) are medicines that combine more than one drug in a single pill, and are also referred to as “cocktail” medicines. “The ministry of health and family welfare has told the drug controller general of India (DCGI) to act on the list of cocktail medicines, which have proven to contain irrational drug combinations,” a senior ministry official told News18.
In September, News18 reported about the meeting of the apex panel – Drugs Technical Advisory Board (DTAB) – to take a final call on selected FDC medicines. But no decision was taken.
The Central Drugs Standard Control Organisation (CDSCO) has drawn up a list of 19 FDCs, which were deemed “irrational combinations”. The list has already been reviewed by the expert committee formed under the chairmanship of Dr MS Bhatia, professor and head, department of psychiatry, University College of Medical Sciences.
The idea behind these medicines is to ease compliance for those required to take multiple medicines as part of long-term treatment or when the combination is proven to have a clear benefit over single-compound drugs. But cocktail drugs have been under the scanner because a lax regulatory framework allowed several unscientific combinations to flood the market; there are also fears that this may increase drug resistance in people.
In 2016, the ministry started a drive to filter out irrational drug combinations from the Indian pharmaceutical industry by banning around 350 FDCs, which impacted over 2,700 branded drugs. Apart from banning cocktail medicines, the DCGI may also focus on banning codeine-based medicines in a phased manner.
The ministry of health and family welfare had asked the former DCGI to review the policy to ban the manufacturing and sale of codeine-based cough syrups after several MPs raised concerns that they were being used more as narcotics than medicines. The decision on this is awaited.
“So far, the ministry has given instructions to act swiftly on FDCs. It is likely that the ban on irrational FDCs may be announced within a month,” the official said, adding, “the work is in progress at DCGI’s office and the ban may be announced in a phased manner.”
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