Centre halves review period for applications to conduct new drug trials

The health ministry has amended the NDCT Rules to cut approval timelines for new drug trials and testing by half, aiming to speed up innovation while easing regulatory processes for most applications

In a bid to accelerate the development of new drugs in the country, the Union health ministry on Wednesday notified an amendment to reduce the review time for applications to conduct clinical trials of new drugs by 50 per cent.

What change has the Centre made to NDCT approval timelines?

In a gazette notification amending the New Drugs and Clinical Trials (NDCT) Rules, 2019, the ministry said the review period for applications seeking permission to manufacture a new drug or an investigational new drug for clinical trials, or to conduct bioavailability or bioequivalence (BA/BE) studies, has been reduced from 90 days to 45 days.

 

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 approvals were required earlier for testing new drugs?

Under the existing rules, permission from the Central Drugs Standard Control Organisation (CDSCO) is required to manufacture drugs for the purpose of testing and analysis, generally during the development stage.

How will the amended process work for most applications?

Under the amendment, applicants will no longer be required to wait for formal test permission, except in the case of a limited category of high-risk drugs.

 

Instead, they will only need to intimate the central licensing authority.

 

“The CDSCO has already developed an online process for prior intimation wherein the applicant can generate acknowledgement of filing of the application,” a senior official aware of the matter said.

 

He added that the process will be launched within 45 days.

When will the amended rules come into force?

Initially released as a draft in September last year, the notification was kept open for industry feedback for a period of 30 days.

 

The amended rules will now come into force 45 days after publication of the gazette notification, around early March.

What is the rationale behind the amendment?

The amendment follows a recommendation by the Drugs Technical Advisory Board (DTAB) to shorten approval timelines and introduce a “notification system” for applications related to preclinical and analytical testing.

 

The changes are also expected to help the CDSCO optimise deployment of human resources, thereby improving the efficiency and effectiveness of regulatory oversight.