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The Drugs Controller General of India (DCGI) has sought the drug controllers of States and Union Territories (UTs) to act upon a list of 35 fixed dose combinations (FDCs), which fall under the definition of new drug, which has been licensed by the State drug regulators without prior evaluation of safety and efficacy as per the provisions of the New Drugs and Clinical Trials (NDCT) Rules, 2019.
The national drug regulator has also asked the State and UT drug controllers to review their approval process for such FDCs for strict adherence. The matter may be treated as urgent and serious, added the official.
The DCGI has released a list of 35 such unapproved FDCs which were earlier licensed by the State or UT drug controllers for manufacture, sale and distribution without evaluation of safety and efficacy by Central Drugs Standard Control Organisation (CDSCO) and later on cancelled by the State Licensing Authorities (SLAs) or voluntarily surrendered by manufacturers following the issuance of show cause notices.
This includes combinations including metformin hydrochloride 500 mg as extended release form along with glimepiride 3 mg, and dapagliflozin 10 mg; dextromethorphan hydrobromide 10 mg along with phenylephrine hydrochloride 5 mg per 5 ml syrup and diphenhydramine hydrochloride 12.5 mg and phenylephrine hydrochloride 5 mg per 5 ml syrup; and a capsule comprising rosuvastatin calcium IP equivalent to rosuvastatin 20 mg as immediate release pellets, clopidogrel bisulphate IP equivalent to clopidogrel 75 mg as immediate release pellets and aspirin 150 mg as gastro-resistant pellets, among others.
The drug regulator has said that it has been raising concerns since January, 2013, regarding the grant of manufacturing licenses for sale of the FDC drugs that fall under the definition of a new drug in the country without due approval from DCGI. The same issue was raised from time to time through multiple letters to the respective SLAs that granted permission for manufacturing and marketing of unapproved FDCs.
"With reference to the above subject, it has come to the notice of this Directorate that certain Fixed Dose Combination (FDC) drugs have been licensed for manufacture, sale, and distribution without prior evaluation of safety and efficacy as per the provision of NDCT Rules, 2019, under the Drugs & Cosmetics Act, 1940. This poses a serious risk to public health and safety," said DCGI Dr Rajeev Singh Raghuvanshi in a letter to all State and UT drug controllers.
The 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. Upon issuance of show cause notices to the manufacturers, they have stated that these licenses were granted by the respective SLAs and the companies have not violated any Rules.
"This has resulted in a lack of uniform enforcement of the provision of the NDCG Rules 2019 under the Drugs & Cosmetics Act, 1940 across the country," said Raghuvanshi.
Considering the scenario, the DCGI sought all state and UT drug controllers to review their approval process for such FDCs and ensure strict compliance of the provisions of the Act and Rules, keeping in mind that public health and safety must remain the top priority.
Releasing the list of 35 FDCs, it added that all State and UT drug controllers are requested to ensure that these FDCs and any other unapproved FDCs shall not be allowed for manufacture, sale and distribution in the country and also conduct the investigation and take necessary action as per the provision of NDCT Rules, 2019 and the same shall be intimated to the DCGI's office.
It may be noted that the central drug regulator has earlier initiated action against hundreds of FDCs which were identified as irrational and has not undergone the approval procedure of the CDSCO based on the rules and regulations, as irrational combinations. Some of these decisions have resulted in a series of litigations initiated by the companies against the drug regulatory organisation in various Courts across the country.
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