Don’t clear FDCs sans evaluation of safety data: Drugs regulator
FDC drugs are those that contain a combination of two or more active pharmaceutical ingredients in a fixed ratio and are also referred to as “cocktail” drugs.
The national drugs regulator has issued a directive to state licensing authorities asking them to treat fixed dose combinations (FDCs) strictly as new drugs and not approve them without evaluating adequate safety and efficacy data, according to people familiar with the matter.
FDC drugs are those that contain a combination of two or more active pharmaceutical ingredients in a fixed ratio and are also referred to as “cocktail” drugs.
The central regulator— Central Drugs Standard Control Organisation (CDSCO)— has asked state authorities to review the approvals they are granting for such fixed dose combinations and ensure strict compliance with the provisions of the Drugs and Cosmetics Act 1940 and rules.
“…it has come to the notice of this directorate that certain fixed dose combination drugs have been licensed for manufacture, sale, and distribution without prior evaluation of safety and efficacy as per the provisions of the New Drugs & Cosmetics Rules 2019…,” read the directive issued by Rajeev Singh Raghuvanshi, Drugs Controller General of India.
Raghuvanshi also said in his letter that approval of such unapproved FDCs compromises patient safety and may lead to adverse drug reactions, drug interactions, and other health hazards due to the absence of scientific validation.
“… all the State and Union Territory drugs controllers are requested to review their approval process for such FDCs and ensure strict compliance of provisions of the Act and Rules. Public health and safety must remain the top priority,” he added in his letter.
He also asked states to strictly check for violations, and take necessary action after thorough investigation.
In addition, the central drugs regulator also banned 35 more fixed dose combinations for manufacture, sale, and distribution across the country as part of an exercise to phase out unapproved fixed dose combination drugs from Indian market.
Among the combinations banned are of painkiller nefopam hydrochloride 30mg and anti-fever paracetamol 325mg; anti-diabetic drugs metformin hydrochloride IP 500mg, Glimepiride IP 3mg, and Dapagliflozin Propanediol Monohydrate 10mg; anti-hypertensive drugs Cilnidipine 20mg and Metoprolol succinate 47.5mg; and anti-anxiety drugs and vitamins Pregabalin 75mg, Nortriptyline 10mg, Vitamin D3 2000IU, and Mecobalamin 1,500mcg.
Parliament’s standing committee on health and family welfare in its 59th report in 2012 on the functioning of CDSCO observed that some of the state licensing authorities issued manufacturing licences for a very large number of FDCs without prior clearance from CDSCO. This resulted in the availability of several FDCs in the market which were not tested for efficacy and safety and would put patients at risk. Also, before 1988, combinations of old drugs were not legally deemed to be new drugs but under the new law, the combination is a new drug and needs to follow the approval process.
The government in 2016 had announced the ban on the manufacture, sale and distribution of 344 fixed drug combinations after an expert panel’s recommendations.
Last year in October, the government banned 156 FDCs. In June 2023, 14 FDCs that were part of those 344 drug combinations were banned. Many of the FDCs banned over the years were also from those 344 drug combinations.