DCGI tightens API licensing rules for bulk drug imports to boost quality and safety
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Summary: India’s drug regulator has tightened API import licensing rules to improve quality checks and curb substandard medicines.
To improve quality controls and ensure patient safety, India's pharmaceutical regulator has changed the rules for importing active pharmaceutical ingredients (APIs), which are the key materials needed to make medicines.
Under the new guidelines, companies will need to meet tougher regulatory and compliance requirements to get or renew their licences for importing APIs. The emphasis is on making sure these ingredients meet global quality benchmarks and come from manufacturers that follow proper safety and production practices.
Officials at the DCGI say this is part of a broader push to strengthen India’s medicine supply chain. Even though India is a major player in the global generics market, concerns around the quality of imported APIs have lingered for years. Officials want stricter licensing rules so only trusted, high-quality ingredients are used, lowering the risk of unsafe or poor-quality medicines reaching people.
People in the business feel the move will force importers to be more cautious about where they get their APIs from. Simultaneously, more checks delaying approvals
in the short run is a concern, particularly while businesses adjust to the new system. Startups or small businesses in particular could find the change harder without additional support or guidance.
The Health Ministry has clarified that this is not about cutting off imports, but about raising quality standards. Importers will now need better traceability and stronger proof of good manufacturing practices, bringing India’s system closer to international norms while keeping public health at the centre.
Regulators have stated that the changes were carefully calibrated to strike a balance: improve patient safety and medicine quality without unduly restricting imports that Indian manufacturers rely on.
As new regulations go into effect, businesses and industry associations are expected to seek clarification on finer details, such as submission dates and how compliance will be tracked, even as lawmakers emphasise improved drug quality control.
