Centre scraps prior approval system for BA/BE studies of low-risk drugs

The health ministry has amended clinical trial rules to replace prior approvals for low-risk BA/BE studies with simple online intimations, a move aimed at cutting delays, easing compliance

In a bid to reduce regulatory burden for medicine exporters and clinical research, the Union Ministry of Health and Family Welfare has notified an amendment removing the requirement of prior approvals for low-risk bioavailability or bioequivalence (BA/BE) tests meant to generate data for export purposes.

 

What are BA/BE studies and why are they important? 

BA/BE studies are used in the pharmaceutical industry to demonstrate that a generic drug is therapeutically equivalent to a branded drug, or that a new formulation performs comparably to a standard dose.

 

What exactly has changed in the approval process? 

In a gazette notification amending the New Drugs and Clinical Trials (NDCT) Rules, 2019, this licensing requirement has now been replaced by a simple online intimation to the drug regulator.

 

“CDSCO processes around 4,000 to 4,500 BA/BE study applications every year, and the revised mechanism is expected to significantly reduce procedural delays,” an official in the know said.

 

How does the reform affect test licences for drug development? 

Similarly, the Central Drugs Standard Control Organisation (CDSCO) announced doing away with the requirement of a test licence for the manufacture of small quantities of drugs intended for examination, research or analysis purposes.

 

“As a result, the industry will no longer be required to seek a test licence and may proceed with pharmaceutical development upon submitting an online intimation to CDSCO, except in the case of high-risk drugs such as cytotoxic, narcotic and psychotropic substances,” the health ministry said in a statement.

 

What impact is the ministry expecting from the move? 

The ministry added that the reform is expected to lead to a minimum saving of 90 days in the drug development life cycle, providing a significant boost to pharmaceutical research and innovation.

 

How will the new system be implemented? 

A dedicated online module will be made available on the National Single Window System (NSWS) and the SUGAM portal, allowing industry to submit intimations in a transparent and hassle-free manner.

 

How does this fit into broader regulatory easing? 

The move comes days after the government reduced the statutory processing timeline to manufacture a new drug or an investigational new drug for clinical trials, or to conduct BA/BE studies, from 90 days to 45 days.

 

“Considering that CDSCO processes approximately 30,000 to 35,000 test licence applications annually, the reform is expected to substantially reduce regulatory burden and benefit a large number of stakeholders,” the official said.