Industry Odisha Bureau, Sep 15: The government is planning to simplify approval rules for bioavailability and bioequivalence (BA/BE) studies used in domestic drug approvals.
Under the new proposal, applicants could start select BA/BE studies simply by informing the drug regulator. This removes the need for prior permission in many cases.
The Drugs Technical Advisory Board is expected to discuss this proposal later this month, according to people familiar with the matter.
A similar system already exists for BA/BE studies conducted for export purposes.
Separately, the government wants to halve import licence timelines for new drugs. Applications under Form CT-17, covering testing of new drugs and reference products, currently take 90 working days. This may soon drop to 45 days.
The health ministry had asked regulators to review Rules 67 to 70 of the New Drugs and Clinical Trials Rules, 2019. The goal is easier compliance and better workforce planning.
BA/BE studies play a key role in approving generic drugs in India. Faster clearances could speed up patient access to affordable generics.
High risk categories excluded
Not all drug categories will benefit from the relaxed norms. Sex hormones, cytotoxic drugs, and beta lactam antibiotics remain excluded.
Vaccines, cell and gene therapies, and live microorganism biologics also stay outside the new system. Narcotics and psychotropic substances face the same exclusion.
These categories will continue under the existing licensing framework. Officials say this reflects the higher risk and scrutiny these products demand.
The move is part of broader efforts to improve ease of doing business in India’s drug regulatory space.
