NEW DELHI: In a move that could help expedite the launch of cutting-edge therapies in India, the Centre has decided to waive local trials for drugs and vaccines that are more advanced than current standards and have been approved in US, UK, Japan, Australia, Canada and EU. These can be launched in Indian market directly, subject to approval from CDSCO, India’s top drug regulatory body, according to an executive order issued by govt.
Rethink on trials to ease entry of breast cancer, leukaemia drugs
USA, UK, Japan, Australia, Canada and EU have strong regulatory mechanisms in place for drug approval.Local trials were required in most cases until now, among other reasons, to rule out any potential difference in the safety and efficacy of drugs on Indian population. A top health ministry official said such differences can affect 0.1 to 0.2% of the population.
“For that, we did not want to deprive the rest of the patients/population who may be needing those medicines, hence this decision,” the official said. “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.
One of the examples of drug categories that may benefit from govt decision is Chimeric antigen receptor (CAR) T-cell therapy that are already approved in the US for treating leukaemia. They might get speedy approval for use in India as well. Sacituzumab govitecan, used to treat breast cancer that has spread in the body, isn’t available in India currently. With this new govt policy, this drug may soon find a way into the Indian market, Dr P Raghu Ram, founding director of Hyderabad-based KIMS — Ushalakshmi Centre for Breast Cancer Diseases, said.
Dr Pooja Sharma, project lead, patient advocates for Clinical Research (PACER), said local clinical trials were earlier considered an important part of the drug regulatory process in India to ensure that genetic, metabolic and other local differences may be factored in while giving approval.
Dr Sharma said this will not mean any increased risk because the regulator will ensure post marketing monitoring through surveillance and post marketing clinical trials.
Rethink on trials to ease entry of breast cancer, leukaemia drugs
USA, UK, Japan, Australia, Canada and EU have strong regulatory mechanisms in place for drug approval.Local trials were required in most cases until now, among other reasons, to rule out any potential difference in the safety and efficacy of drugs on Indian population. A top health ministry official said such differences can affect 0.1 to 0.2% of the population.
“For that, we did not want to deprive the rest of the patients/population who may be needing those medicines, hence this decision,” the official said. “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.
One of the examples of drug categories that may benefit from govt decision is Chimeric antigen receptor (CAR) T-cell therapy that are already approved in the US for treating leukaemia. They might get speedy approval for use in India as well. Sacituzumab govitecan, used to treat breast cancer that has spread in the body, isn’t available in India currently. With this new govt policy, this drug may soon find a way into the Indian market, Dr P Raghu Ram, founding director of Hyderabad-based KIMS — Ushalakshmi Centre for Breast Cancer Diseases, said.
Dr Pooja Sharma, project lead, patient advocates for Clinical Research (PACER), said local clinical trials were earlier considered an important part of the drug regulatory process in India to ensure that genetic, metabolic and other local differences may be factored in while giving approval.
Dr Sharma said this will not mean any increased risk because the regulator will ensure post marketing monitoring through surveillance and post marketing clinical trials.
