Centre Mulls Easing BA/BE Norms for Domestic Drug Approvals, CT-17 Timeline Cut to 45 Days
New Delhi: The government is considering easing regulatory requirements for bioavailability and bioequivalence (BA/BE) studies intended to support domestic drug approvals.
Under the proposal, applicants could begin eligible studies by notifying the drug regulator, without first obtaining its permission.
According to the news reported by ET, the proposal has been listed for discussion at a Drugs Technical Advisory Board (DTAB) meeting scheduled this month, people familiar with the development said.
A notification-based route had previously been introduced for certain BA/BE studies undertaken for export purposes. The proposed change would extend a similar approach to eligible studies supporting domestic approvals.
The government is also considering reducing the processing period for formal import licence applications under Form CT-17 from 90 working days to 45 working days. These applications concern new drugs and reference products imported for analytical and non-clinical testing. The proposed reduction forms part of efforts to make regulatory procedures easier for businesses.
A government document referred to in the report stated that the health ministry had asked the drug regulatory authority to review Rules 67, 68, 69 and 70 of the New Drugs and Clinical Trials Rules, 2019. The review was sought in line with an earlier gazette notification aimed at improving ease of doing business and rationalising the workforce.
The document described the current requirement for a licence to import new drugs for testing and evaluation, with a prescribed application-processing period of 90 days.
BA/BE studies play an important role in the approval of generic medicines in India. Shortening regulatory timelines could help affordable generic medicines reach patients sooner.
However, the proposed prior-intimation route would exclude sex hormones, cytotoxic drugs, beta-lactam antibiotics, vaccines, cell and gene therapy products, biologics containing live microorganisms, and narcotic and psychotropic drugs.
ET reported that it had reviewed a copy of the government document. Citing a person familiar with the matter, the report said the excluded categories would remain subject to formal licensing requirements because they require greater regulatory scrutiny before import and testing.
