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The Union health ministry’s proposal to revamp wholesale licensing framework for bulk drugs, active pharmaceutical ingredients (APIs) and key starting materials (KSMs) will plug regulatory gap in the supply chain, according to Harish Jain, national president, Federation of Pharma Entrepreneurs (FOPE).
The proposal was discussed and agreed at a recent Drug Consultative Committee (DCC) meeting to ensure effective regulatory oversight. Under the existing system, bulk drugs and finished formulations operate under a common licence.
Sharing his views Dr Viranchi Shah, national spokesperson, Indian Drug Manufacturers' Association (IDMA) said, “Separate licenses for APIs at wholesale level will help better regulatory oversight of API supply chain. It will also help formulation companies in better vendor management.”
DCC, the advisory committee that advises the Central and state governments on matters related to uniform implementation of drugs regulations, in its meeting on November 17, 2025 had discussed and agreed a proposal to introduce separate requirements and forms for wholesale license for bulk drugs and excipients. “DCC deliberated the matter in detail and agreed with the proposal for separate requirements and form(s) for bulk drugs and excipients," as per the minutes of the meeting.
This comes in the wake of concerns around transparency in the raw material supply following deaths due to cough syrups contaminated with diethylene glycol (DEG). The industry highlighted that this move is urgently required for closer monitoring of high-risk solvents.
Echoing similar views, Ritesh Shah, joint managing director, Anuh Pharma, a bulk drug company, said, “This is a positive and much-needed move. Having a separate licence for bulk drugs, APIs, and KSMs will bring better clarity and improve traceability in the supply chain.”
Shah further added that what matters now is that the process remains simple, digital, and practical for genuine manufacturers and traders. The industry should be given enough time to transition, with clear guidance from regulators. If implemented thoughtfully, this step can improve patient safety and further strengthen India’s credibility as a reliable global pharma supplier.
He explained that this move would lead to the creation of a proper registry of nearly 1.2 million bulk drug traders. This will also help reduce grey-area practices and improve accountability under the oversight of the Drugs Controller General of India (DCGI).
DCC also sought the Central Drugs Standard Control Organisation (CDSCO) to examine matters related to regulation of formulation intermediates and their quality standards.
The Committee also suggested incorporating provision in such a way that the information regarding wholesalers dealing with Narcotic Drugs and Psychotropic Substances (NDPS) category is captured in the license.
It also recommended that "qualification of competent person may be degree in science with one year experience in dealing of such raw materials or a registered pharmacist."
Besides, the Committee was apprised on regulation of formulation intermediates such as Direct Compressible granules or pellets containing API and other excipients for direct compression/capsule filling which have to be considered as formulated bulk to meet the applicable quality standards such as dissolution profile, etc.
While the drug pellet segment in the country is well-established, it currently lacks exclusive regulatory guidelines, according to the industry.
Pellets have been considered as semi-finished formulations and manufacturing licenses have been issued for each drug, strength wise. However, different players from the formulation industry may seek different strengths of pellets even for same dose capsule pellets to suit their particular requirement.
The bulk drug manufacturers may have to seek separate licenses even if the variation is very minor, for instance a 0.5%, which is causing delay in meeting the customer requirement, said bulk drug manufacturers. They proposed a system where the manufacturing license for drug pellets may be issued based on strength ranges, based on market experience for individual drugs.
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