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Health Ministry : Now Clinical Trials will be evaluated on parameters given by Supreme Court

 

Clinical courses

(12th September, 2014); Now in India, all the Global Clinical Trials (GCTs)/New Clinical Trials (NCEs) should be evaluated on regard to parameters given by Honorable supreme court. Drugs controller general of India (DCGI) clearly mentioned on all parameters in their notice.

The clinical trials on new drugs are regulated under the provisions of Drugs & Cosmetics Rules 1945 as amended form time to time. The detailed requirements and guidelines for undertaking clinical trials are specified under Rule 122DAA, Rule 122DAB. Rule 122DAC, Rule 122DD, Rule 122E and Schedule Y of the said rules and other relevant provisions.

Hon’ble Supreme Court, has passed an order regarding clinical trials on dated 21/10/2013. As per the said order all the GCTs/NCEs should be evaluated having regard to three parameters, namely, (i) assessment of risk versus benefit to the patients, (ii) innovation vis-a-vis existing therapeutic option and (iii) unmet medical need in the country.

In view of the above, it has been decided with the approval of the Ministry of Health & Family Welfare, all the applications for the conduct of clinical trials of new drugs in India should invariably provide the information on assessment of risk versus benefit to the patients, innovation vis-a-vis existing therapeutic option and unmet medical need in the country.

And in notice of DCGI, they clearly mentioned that CRO and related organizations should adhere on above parameters while they apply for any trials.


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