India Pharma Outlook Team | Tuesday, 15 September 2026
Easier drug rules could reshape how India’s pharma companies bring medicines to market. The Centre has proposed simpler norms that let companies start certain bioavailability and bioequivalence studies after merely informing the regulator.
Officials have also moved to cut the processing time for key import licenses in half. These changes aim to speed up the rollout of affordable generics and improve the ease of doing business.
If the Drugs Technical Advisory Board clears the proposals this month, Indian drug makers could see faster development cycles and quicker patient access to lower-cost versions of essential medicines.
The government wants to simplify the regulatory process for bioavailability and bioequivalence (BA/BE) studies needed for domestic drug approvals. Under the new approach, applicants could begin eligible studies after intimating the drug regulator rather than seeking its prior permission. A similar intimation system already exists for specified BA/BE studies conducted for export purposes.
At the same time, the government plans to reduce the timeline for processing formal import license applications under Form CT-17. These licenses cover new drugs and reference products meant for analytical and non-clinical testing. The current 90-working-day window would shrink to 45 working days.
Key elements of the proposals include:
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The easier intimation route will not apply to every product. Sex hormones, cytotoxic drugs, beta-lactam antibiotics, vaccines, cell and gene therapy products, biologics that contain live microorganisms, and narcotics and psychotropic drugs will remain outside the new system.
For these high-risk categories, companies must still obtain formal licenses before importing or testing the materials. Regulators will keep the higher level of scrutiny these products require.
Bioequivalence studies form a critical step in the generic drug approval process in India. Any reduction in the time needed for these studies can directly speed up the arrival of affordable generic versions on the market. Faster import-license processing will also help companies bring reference products into the country more quickly for testing.
The health ministry had earlier asked the drug regulatory authority to examine Rules 67, 68, 69 and 70 of the New Drugs and Clinical Trials Rules 2019. The review aimed to align the rules with earlier gazette notifications that focused on ease of doing business and workforce rationalization.
Taken together, the proposals give Indian pharma companies a clearer path to shorter development timelines. They reduce procedural delays without lowering safety standards for sensitive products.
If the Drugs Technical Advisory Board approves the changes, the industry could move eligible studies and testing materials through the system with greater speed and predictability.
