Expert Panel Asks States, UTs to Compile List of Cocktail Drugs Sold in Markets, Sets Two-Week Deadline

A panel of experts has called on states and Union Territories to compile a list of antibiotic combinations sold in their markets and monitor the sales of unauthorised cocktail drugs to prevent antibiotic resistance, News18 has learnt.

The move, which has been initiated by the sub-committee under the apex panel Drug Technical Advisory Board (DTAB), is part of an effort initiated by the country’s top medical research body — Indian Council of Medical Research (ICMR).

The 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 state and UTs have been instructed to send the list “within the next two weeks” in a letter written by the Drug Controller General of India (DCGI), head of India’s drug regulatory body Central Drugs Standard Control Organisation(CDSCO).

DCGI Rajeev Singh Raghuvanshi’s May 16 has been accessed by News18. The decision to create a list was taken during the first meeting of the sub-committee on May 1.

The idea behind these combination 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. However, these drugs have been under the scanner because a lax regulatory framework allowed several unscientific combinations to flood the market. These drugs are also responsible for increasing drug resistance in people.

Timeline of efforts to control misuse of antibiotic drug combos

Last year, in April, the meeting of the expert group at ICMR’s headquarters in New Delhi decided to create a pathway for strategic access to new antibiotics and regulation against excessive and irrational use of antibiotics in India.

After the expert panel meeting in April last year, another meeting was held under the chairmanship of Dr Atul Goel, Directorate General of Health Services (DGHS), to discuss how to regulate antibiotic overuse and irrational use, the letter said.

“The committee has decided that CDSCO will be responsible for six monthly reviews of various fixed drug combinations of antibiotics marketed in various states.”

In January, the proposal was placed before the Drug Technical Advisory Board constituted a sub-committee to examine the matter in detail and give their recommendation

First meeting of sub-committee

The sub-committee in its first meeting decided to request state licencing authorities (SLAs) to “provide the list of antibiotic combinations licensed by them for manufacturing and marketing in their respective states.”

It also requested SLAs “to monitor the availability of unapproved antibiotic combinations if any, moving in the market under their jurisdiction and intimate CDSCO on priority.”

“…you are requested to provide the list of antibiotic combinations licensed by you till date within 2 weeks,” the letter said.

“You are also requested to monitor the availability of unapproved antibiotic combinations if any moving in the market under your jurisdiction and take necessary action under the provisions of the Drugs and Cosmetics Act & Rules and intimate to CDSCO from time to time on priority.”

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