India waives local trials for drugs approved by global regulators
The Indian government has waived the requirement for local clinical trials for drugs and vaccines, already approved by regulatory agencies in the US, UK, Australia, Japan, Canada, and the EU. Per TOI, this directive was issued via an executive order and is expected to expedite the availability of advanced medical treatments in India. The policy change allows these therapies to directly enter the Indian market, upon approval from the Central Drugs Standard Control Organization (CDSCO), India's top drug regulatory body.
Rationale behind policy change
The decision to waive local trials was made to avoid depriving patients who may need these medicines. A senior health ministry official explained that differences typically affect only 0.1-0.2% of the population, making local trials less critical in many cases. "For that, we did not want to deprive the rest of the patients/population who may be needing those medicines, hence this decision," they said.
New shift will expedite drug launches
The official also noted that there have been many instances when reputed companies postponed or faced delays in launching a new drug, already approved in major markets like the EU, because they couldn't undertake or complete local trials. "Govt order will do away with this need," they added. This policy change is tipped to facilitate faster introduction of innovative treatments into the Indian market.
Advanced treatments for cancer could soon be available
Chimeric Antigen Receptor (CAR) T-cell therapy, already approved in the US for treating leukemia, could see expedited approval in India. Similarly, Sacituzumab govitecan, a treatment for advanced breast cancer currently unavailable in India, may soon become accessible. The policy change is expected to ease the entry of advanced therapies for major diseases into the Indian market.
Post-marketing surveillance to ensure drug safety
Dr. Pooja Sharma from Patient Advocates for Clinical Research (PACER), emphasized that while local trials are being waived, CDSCO will still ensure rigorous post-marketing surveillance and clinical trials, to monitor drug performance and safety in India. "This will not mean any increased risk because the regulator will ensure post marketing monitoring through surveillance and post marketing clinical trials," Dr. Sharma said.
