Zee Media Bureau
New Delhi: In a new development, the government of India has introduced a series of steps that would help promote more clinical research in the country.
In its latest circular issued this week, the Central Drug Standard Control Organization (CDSCO) said if a new drug was already approved outside India after conducting pre-clinical/toxicological studies on animals, such studies are not required to be repeated while approving their proposal for import or manufacture in India unless some specific concerns are raised.
The move comes in wake of concerns raised by stakeholders which complained of repeat tests and data submissions to authorities in meetings held in August and October with top officials from the health ministry.
In another decision, the Drug Controller General of India (DCGI) has said that Ethics Committees can also approve requests for new clinical trial sites and new investigators to be added to a clinical trial without CDSCO’s approval as long as the ethics committees conduct “due diligence.”
As per the new norms, researchers will no longer need the permission of the Drug Controller General of India (DCGI) for “academic/research purposes that are non-regulatory in nature.” However, the Ethics Committee is still required to inform the DCGI of the study and the DCGI will have 30 days to object to the decision to not seek its approval.
