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THE Union Health Ministry is working on a proposal to provide accreditation to clinical trial centres, investigators and ethics committees — all of which will kept be out of the purview of...
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Presently there is no specific provision under Drugs and Cosmetics Rules for payment of compensation in case of clinical trial related injury or death of the subject. However, the Good Clinical Practice...
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n the Drugs and Cosmetics Rules, 1945, in Part X-A, after 122Dab, the following rule shall be inserted, namely:- “122 DAC. (1) Permission to conduct clinical trial- The licensing Authority as defined...
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In the Drugs and Cosmetics rules 1945, after rule 122DC, the following rule shall be inserted, namely:- 122 DD. Registration of Ethics Committee-(1) No Ethics committee shall review and accord its approval...
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The Drug Controller General of India (DCGI) has planned to meet senior officials from all the zonal offices across the country in the coming week to assess and examine the regulatory mechanism...
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Under rule 122 DD Registration of Ethics committee (EC) – No ethics committee shall review and accord its approval to a clinical trial protocol without prior registration of the committee with the...