CDSCO allows immediate lab testing of drugs to speed up approvals

CDSCO will permit drugmakers to begin testing samples as soon as applications are filed, shifting detailed scrutiny to later stages to shorten approval timelines and ease compliance

The Centre has allowed companies to begin lab testing immediately after filing applications instead of waiting for detailed scrutiny, in a move to expedite approvals for manufacture, or import of new drugs. 

 

In a circular dated February 23, the Central Drug Standards Control Organisation (CDSCO) said that any No Objection Certificates (NOC) for testing of drug samples at designated government laboratories shall be issued immediately upon receipt of applications.

 

Testing is a mandatory prerequisite before approval and is conducted at four government laboratories, according to submitted specifications. These are Indian Pharmacopoeia Commission (IPC), Mumbai’s Central Drugs Testing Laboratory (CDTL), Central Drugs Laboratory at CRI Kasauli and the National Institute of Biologicals in Noida.  

   

These labs conduct tests as per submitted specifications and submit reports to CDSCO for consideration. 

 

Earlier, the regulator examined detailed specifications related to formulation types, dosage forms, product development reports and compliance with relevant pharmacopoeia monographs submitted by applicants before issuing permission for testing. 

 

Scheduled to come into force from June 1, 2026, the move aims at shifting focus to faster movement of files while retaining technical scrutiny for later stages.

 

Applicants will be required to submit finalised regulatory specifications, basing them on the prevailing pharmacopoeia standards product-specific quality management system (QMS).

 

“In cases where specifications are revised or updated after review or comments by CDSCO, a fresh NOC for testing shall be issued for re-testing at the designated laboratory as per the revised specifications,” the circular added.

 

The move comes at a time when the government has made amendments to the NDCT Act to reduce regulatory burden and promote Ease of Doing Business (EoDB). The modifications pertained to manufacturing of small quantities of drugs intended for examination, research, or analysis purposes

 

“These amendments are aimed at simplifying regulatory processes, reducing approval timelines, and enabling faster conduct of clinical research and pharmaceutical development in the country,” said an official in the know.

 

Earlier this month, the Union Health Ministry eliminated the requirement of a provisional registration certificate for ethics committees involved in biomedical and health research.

 

The ministry also proposed amendments categorising the post-approval changes of new drugs, both imported and manufactured in the country, based on the impact of the changes on the quality of the drug.

 

It also made changes in the rules to ease the process of approval for manufacturing of a new drug or investigational new drug for analytical and non-clinical testing, and to reduce the timeline for approval of manufacturing of a new drug or investigational new drugs for tests.

 

In another step to expedite clinical research, the requirement of obtaining prior permission for certain categories of low-risk bioavailability/bioequivalence (BA/BE) studies has been dispensed with.

 

Such studies may now be initiated on the basis of a simple online intimation to the Central Drugs Standard Control Organisation (CDSCO), enabling faster commencement of studies, particularly for the generic pharmaceutical industry.