The Central Drugs Standard Control Organization (CDSCO) is taking proactive steps to speed up the testing process for drugs seeking approval for import or manufacturing in India. The regulator has announced that companies will now receive the No Objection Certificate (NOC) more quickly, helping to streamline regulatory procedures and reduce approval timelines.
According to the circular, CDSCO receives many applications for grant of permission to import or manufacture new drugs for sale or distribution as well as for the issuance of registration certificates for drug imports. Currently, the organization examines the product specifications submitted by applicants and then issues a NOC for testing.
At present, the specifications submitted by applicants are:
- Type of formulation, dosage form, Critical Quality Attributes (CQAs), and general characteristics of the product.
- Product development reports, forced degradation studies, and other relevant data, in accordance with applicable guidelines.
- Compliance with relevant Pharmacopoeial Monographs.
- Provisions of General Chapters of the Indian Pharmacopoeia (IP) or other pharmacopoeias specified in the Second Schedule of the Drugs and Cosmetics Act, 1940 and the Rules made thereunder.
Before approval, drug samples are tested at designated laboratories. These include the Indian Pharmacopoeia Commission in Ghaziabad, the Central Drugs Testing Laboratory in Mumbai, the Central Drugs Laboratory in Himachal Pradesh, and the National Institute of Biologicals in Noida.
These laboratories conduct testing based on the specifications submitted by the applicants, and the test reports are then submitted to CDSCO for final consideration.
To make the approval process faster, CDSCO has decided that the NOC for testing drug samples will now be issued immediately after receiving the application in the concerned division based on Prevailing Pharmacopoeia standards and Product Specific Quality Management System (QMS). This step is expected to reduce delays and improve the overall efficiency of the regulatory review process.
Applicants will also be required to submit finalized regulatory specifications while filing the application. These specifications must be based on relevant pharmacopoeial standards and the applicable provisions under the Drugs and Cosmetics Act, 1940.
The new system will come into effect from 1 June 2026. CDSCO has circulated the directive to all divisions and relevant testing laboratories for necessary action.
Earlier in 2026, the regulator amended the New Drugs and Clinical Trials Rules, 2019 to simplify the test licence pathway and reduce approval timelines. Under the amendment, certain manufacturers can begin limited production for analytical and non-clinical testing after submitting a prior intimation and receiving acknowledgement, while regulatory timelines for approvals have also been reduced from 90 working days to 45 working days.
The Indian regulator appears to be focused on speeding up drug development and approvals, reducing bureaucratic delays, encouraging pharmaceutical innovation in India, and at the same time maintaining regulatory oversight through mandatory testing at designated laboratories.
