Regulator Streamlines Approval Process For Import, Marketing Of Experimental Drugs

Published 11 August 2026 · india

News india Regulator Streamlines Approval Process For Import, Marketing Of Experimental Drugs Regulator Streamlines Approval Process For Import, Marketing Of Experimental Drugs Reported By, Last

News india Regulator Streamlines Approval Process For Import, Marketing Of Experimental Drugs Regulator Streamlines Approval Process For Import, Marketing Of Experimental Drugs Reported By, Last Updated: August 11, 2026, 14:45 IST The circular, dated August 10, seen by News18, said that CDSCO's New Drugs Division had been receiving a growing number of such applications Rapid Read Representative image India’s apex drug regulator, the Central Drugs Standard Control Organisation (CDSCO), has streamlined the approval process for pharma companies seeking to import and market new drugs not yet approved anywhere in the world, News18 has learnt. These are drugs still being tested on Indian patients as part of ongoing or completed global Phase III clinical trials. Pharma companies often run global clinical trials — including in India — for drugs that are still awaiting approval from any regulator worldwide.

Once Phase III trials, the final stage before a drug can be approved for the market, are completed or well underway with Indian patients enrolled, companies frequently seek permission to import and market the drug in India even before it clears approval elsewhere. This lets them bring promising therapies to Indian patients sooner, stay ahead in a competitive market, and build on the trial data already generated in the country rather than waiting for a foreign regulator to act first. The circular, dated August 10, seen by News18, said that CDSCO’s New Drugs Division had been receiving a growing number of such applications. An internal technical committee examined the matter and opined that these applications — since the drug is still under review by foreign regulators — require “a comprehensive evaluation of non-clinical and clinical data in accordance with the provisions of the NDCT Rules, 2019".

WHAT DO THE NDCT RULES SAY? The New Drugs and Clinical Trials (NDCT) Rules, 2019 lay down how new and investigational drugs are tested and approved in India, including the framework under which a drug not yet cleared anywhere in the world can still be permitted for import and marketing based on trial data, including data generated from Indian participants. To bring clarity and consistency, CDSCO has now directed that all such applications be routed exclusively to a separate division at its New Delhi headquarters. By consolidating the process under one specialised division equipped to assess complex, still-evolving clinical data, the government aims to make the review faster and more predictable for pharma companies looking to bring next-generation drugs to the Indian market. News18 Newsletter Handpicked stories, in your inbox A newsletter with the best of our journalism submit About the Author Himani Chandna Senior Associate Editor Himani Chandna, Senior Associate Editor at CNN-News18, tracks healthcare, pharma and medical research, bringing clarity to complex science and policy.