New Delhi: The government has declared more than 450 fixed dose combination (FDCs) medicines related to vitamins and minerals as “rational”, ThePrint has learnt.
When a combination drug has a proven advantage over a single-compound drug, it is categorised as ‘rational’. All drugs used in combination should act by different mechanisms and the overall toxicity should not be high.
The move is part of the Centre’s efforts to remove irrational drug combinations from the market, which was initiated in 2016, by banning around 350 FDCs and impacting over 2,700 branded drugs.
FDC medicines combine more than one drug in a single pill. It is under scanner because when several drugs, such as antibiotics, are clubbed together, it may lead to drug resistance of the disease-causing organism.
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In the latest development, the Ministry of Health and Family Welfare has approved the list of drugs which have been declared rational by the Professor C.K. Kokate Committee, the apex panel which reviewed more than 6,600 FDCs since 2016 and classified them under four categories — irrational, require further deliberations, rational and require additional data generation.
Until now, the government has cleared more than 2,100 FDCs. “Further there are now more 471 FDCs relating to vitamins, minerals and micronutrients, etc., which have been declared as rational by Prof. Kokate Committee and report of the committee has been accepted by the Ministry,” said Drugs Controller General of India (DCGI), V.G. Somani in a 34-page letter written to state licensing authorities (SLAs)
“Accordingly with the approval of the Ministry of Health and Family Welfare, it has been now decided to follow the following pathway for grant of product licenses by SLAs for these FDCs…,” said the letter dated 3 August, which was accessed by ThePrint and lists the procedure for grant of manufacturing and marketing approvals.
Safety of FDCs to monitored regularly
In the letter, the DCGI also notified the process which manufacturers and stakeholders will follow for obtaining the manufacturing license.
The letter is marked to all state and Union Territories’ SLAs along with a copy to the health ministry and all zonal and sub zonal offices of the Central Drug Standard Control Organisation (CDSCO).
According to the letter, the onus of verifying the quality of such fixed dose combinations of each manufacturer before granting product license to manufacturer and market, lies completely with the SLA.
The safety of these drug combinations will be monitored regularly. “Every manufacturer permitted to manufacture these FDCs shall submit the periodic safety update reports (PSURs) as per New Drugs and Clinical Trial Rules-2019 to the central licensing Authority … Failure to submit the PSURs shall be considered as contravention of these rules,” Somani warned in the letter.
“You are therefore requested to ensure that no product license is granted in respect of the FDCs which are not mentioned in the attached list,” he said referring to an attached ‘Annexure A’ which contained the names of 471 rational FDCs.
Why FDCs are under scanner
Fixed drug combinations or FDCs came under the scanner after the government caught several big pharma giants selling various tweaked versions of drug combinations under multiple brand names, which were marketed as cheaper and more convenient alternatives.
The government had banned several drug combinations sold under popular brand names such Crocin Cold and Flu, D-Cold Total, Chericof and Nimulid. However, several pharma companies have challenged the ban in multiple courts, owing to which they remain on shelves.
The therapeutic value of these FDCs, otherwise, has long been questioned by experts due to the fear of causing drug resistance in the body against multiple drugs.
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