Priyanka Tiwari
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The Central Drugs Standard Control Organisation (CDSCO) acts as the apex drug regulatory authority in India. It has now instructed all state and union territory drug controllers to cease manufacture, sale, and distribution of 35 unapproved fixed-dose combination (FDCs) including analgesics, dietary vitamins, and anti-diabetic drugs.
The finding came after it was noted that some of these FDCs were being permitted at the state level without the mandatory central safety and efficacy evaluation of the FDCs and FDCs as per the Drugs and Cosmetics Act of 1940.
CDSCO Cites Serious Public Health Risks
The directive was signed by Drugs Controller General of India (DCGI) Rajeev Raghuvanshi, who pointed out the health consideration concerning such approvals. In his letter, these drugs had evaded all critical assessments carved in the New Drugs and Clinical Trials (NDCT) Rules 2019.
Raghuvanshi's comments regarding the unrestricted commercial availability of these FDCs are terrible risk to public health and severely tarnish drug control and regulation procedures.
SOPs and Workflow CD with Submit and Obtain Approval
The CDSCO expects the drug regulators in the states as well as union territories to follow a control checklist and ensure that all required national guidelines are considered while giving approvals for FDCs. It strives to ensure complete administrative integrity with respect to nationally accepted guidelines and compliance with zero tolerance for violation.
The manufacturers (in question) who received show-cause notices defended their case saying that their licenses had permissively originate d from state authorities and subservience to prevailing statutes, were lawfully issued more or less without going against the rules. National authority, however, is authoritative has largely pointed out that such practice has given rise to disorganization in observing national drug law.
List of 35 Unapproved FDCs Proposed by State are Attached Herewith
Based on the letter, a bundle of 35 FDCs that were offered previously by state employed assessors within the jurisdiction on deemed merit without necessary appraisal from external certifying agencies are bound to be executed. The drugs which are pathogenically sealed no longer allowed to be produced and sold again indefinitely will be placed under the review federal benchmarks.
