2 weeks Ago
CDSCO has ordered all states and Union Territories to stop the production, sale, and distribution of 35 fixed-dose combination being manufactured without drugs safety and efficacy review India’s top health regulatory body, the Central Drugs Standard Control Organisation (CDSCO), has ‘urgently’ ordered all states and Union Territories to stop the production, sale, and distribution of 35 fixed-dose combination drugs and any other unapproved medicines, News18 has learnt. The list of these drugs includes painkillers, anti-diabetic medicines, hypertension drugs, neuropathic pain relievers, fertility drugs and nutrition supplements. These medicines contain multiple drug combinations in one pill without a valid scientific rationale.
Moreover, all states and UTs have been asked to reassess their approval procedures for such FDCs and ensure strict adherence while approving combination drugs. 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 Drug Controller General of India (DCGI) – who heads CDSCO – has written a letter to drug controllers of all states and UTs regarding the manufacturing and marketing of “unapproved FDCs" while attaching a list of 35 unapproved FDCs that were earlier licensed by state authorities without CDSCO’s safety and efficacy review, but were later cancelled or voluntarily withdrawn after show-cause notices.
The lack of scientific validation poses risks to patient safety and may lead to harmful side effects. DCGI has asked state and UT drug regulators to conduct the investigation and take necessary actions. In a letter dated April 11 and accessed by News18, DCGI Rajeev Singh Raghuvanshi warned, “This poses a serious risk to public health and safety," and emphasised, “This matter may be treated as urgent and serious".
What does the letter say? The move was triggered after CDSCO found that some FDC drugs were approved without proper safety and efficacy checks. “..
.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," said the letter. “The approval of such unapproved FDC’s compromises patient safety and may lead to adverse drug reactions, drug interactions, and other health hazards due to the absence of scientific validation.
" What Led To Uneven Enforcement Of Rules? The confusion happened because different states gave approval for these drugs without following the same rules. In turn, companies responded when summoned, saying they didn’t break any laws since they got proper licenses from state authorities. Upon issuance of show-cause notices to the manufacturers, the letter said, these pharma companies have stated that “these licenses were granted by the respective Drug Licensing Authorities and have not violated any Rules.
This has resulted in a lack of uniform enforcement of the provision of NDCT Rules 2019 under the Drugs & Cosmetics Act 1940 across the country". Concluding the letter, DCGI has asked all the state and union territory drug controllers “to review their approval process for such FDC’s and ensure strict compliance with the provisions of the Act and Rules.".
