The government is considering a separate licensing framework for bulk drugs, active pharmaceutical ingredients (APIs) and key starting materials (KSMs) as part of a broader effort to tighten regulatory oversight and improve supply chain transparency in the pharmaceutical sector, according to media reports.
The proposed overhaul aims to distinguish bulk drug manufacturing and trading from finished formulations, a move that could bring greater clarity to compliance requirements and improve traceability across the pharma value chain. The framework is also expected to include a registry of bulk drug traders under the supervision of the Drugs Controller General of India (DCGI).
“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,” said Ritesh Shah, Joint Managing Director of Anuh Pharma, a bulk drug manufacturer.
He further adds, “What matters now is that the process remains simple, digital and practical for genuine manufacturers and traders. If implemented thoughtfully, this step can improve patient safety and further strengthen India’s credibility as a reliable global pharma supplier.”
India is one of the world’s largest suppliers of generic medicines and APIs, but the bulk drug segment has historically operated under fragmented licensing structures at the state level. Regulators and policymakers have been working to strengthen oversight, particularly in the context of global quality scrutiny, export compliance, and recent supply chain disruptions.
The government has not yet issued a formal notification.