This new directive, issued via an executive order, will allow these advanced therapies to enter the Indian market directly, contingent upon approval from the Central Drugs Standard Control Organization (CDSCO), India’s top drug regulatory body.
“For that, we did not want to deprive the rest of the patients/population who may be needing those medicines, hence this decision,” TOI quoted the official as saying.
“There have been multiple instances in the past when reputed firms postponed or faced delays in launch of a new drug that had been already approved in major markets such as the EU because they couldn’t undertake or complete local trials. Govt order will do away with this need,” he added.
According to a senior health ministry official, such differences typically affect only 0.1 to 0.2% of the population, making the requirement for local trials less critical in many cases.
The policy change is expected to facilitate the faster introduction of innovative treatments into the Indian market. For example, Chimeric Antigen Receptor (CAR) T-cell therapy, which is already approved in the US for treating leukemia, could see expedited approval in India. Similarly, Sacituzumab govitecan, a treatment for advanced breast cancer, which is not currently available in India, may soon become accessible.Dr. Pooja Sharma, project lead at Patient Advocates for Clinical Research (PACER), emphasized that while local trials are being waived, the CDSCO will still ensure rigorous post-marketing surveillance and clinical trials to monitor the drugs’ performance and safety in the Indian context. This balanced approach aims to expedite access to essential therapies while maintaining high standards of safety and efficacy.
