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Government may exempt critical drugs from local clinical trials

Clinical TrialsThe government has decided to waive off local clinical trials for new drugs indicated for life threatening diseases and diseases of special relevance to Indian health.

The technical committee under the Directorate General of Health Services (DGHS) in a meeting pointed out that it was desirable to expedite the development, uation, and marketing of new therapies where no satisfactory alternative therapy existed. The panel noted that patients and clinicians were willing to accept greater risks from products that treat life threatening and serious diseases than they were from products that treated less serious illnesses.

The experts also said that in such cases, conduct of clinical trial was also a complex, time consuming and costly affairs as such patients required multiple therapy to manage the disease conditions. The experts, therefore, decided to waive off local clinical trials for such drugs. They are now shortlisting the list of such serious and life threatening diseases and the diseases of special relevance, where waiver of local clinical trial for approval of new drugs can be considered.

The panel had earlier also recommended that drugs which were already in the market in well-regulated countries with a good post marketing surveillance for more than four years, and which have a satisfactory report, may be permitted for direct marketing in India, subject to strict surveillance.

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