The Central Drugs Standard Control Organisation has revised its procedure to speed up approvals for new medicines in India. Under the new system, No-Objection Certificates for laboratory testing will be issued immediately after an application is received. This is intended to reduce delays in the drug approval pipeline while regulatory scrutiny continues in parallel.
What Has Changed
Earlier, the regulator first examined detailed technical specifications before allowing testing of a new drug. These included formulation details, dosage form, critical quality attributes and compliance with pharmacopoeial standards. Now, testing can begin at designated government laboratories without waiting for that preliminary scrutiny to finish.
Scope of the Revised Procedure
The change applies to applications for:
- Import or manufacture of new drugs for sale or distribution.
- Registration certificates for drug imports.
- Testing of products at approved government laboratories.
The revised process is meant to improve efficiency in the assessment of new medicines entering the Indian market.
Testing Facilities and Compliance
Laboratory evaluation will be carried out at key institutions, including the Indian Pharmacopoeia Commission in Ghaziabad, the Central Drugs Testing Laboratory in Mumbai, the Central Drugs Laboratory at CRI Kasauli, and the National Institute of Biologicals in Noida. Applicants must still submit finalised regulatory specifications based on current pharmacopoeial standards and product-specific Quality Management Systems.
Implementation and Significance
The revised system will come into force from 1 June 2026. If specifications are changed after review, a fresh NOC will be issued for re-testing under the updated norms. The move is expected to reduce procedural bottlenecks while preserving statutory quality checks for new drugs.
Last Modified: April 28, 2026