Fresh mandatory norms for clinical testing of drugs

the government on tuesday announced amendments to the drugs and cosmetic rules, 1945 to streamline procedures for manufacture and import of new drugs. as per the amended rules, no institution will be allowed to conduct clinical trials, whether for clinical investigation or experiment, for a new drug without the permission of the drug controller general of india. till now, such permission was mandatory only if the drug was sought to be marketed in india. an official statement said, schedule y to the rules that prescribes requirements and guidelines on clinical trials for import and manufacture of new drugs has been amended to make post-marketing surveillance study mandatory.a new appendix 1-a has been introduced to provide for specific requirements for approval of new drugs to guide subsequent applications for permission to manufacture the drug already approved, it added. provision has also been introduced for suspension or cancellation of the permission given to an applicant, if he fails to comply with conditions of approval. to facilitate submission of specific information in proper formats, new application forms or approvals have now been prescribed. and, since technical data needs to be examined by experts, the government has also made provision for evaluation fees in line with global standards. this is meant to keep non-serious players at bay. phase i, or human clinical pharmacology, will require a fee of rs 50,000 and phase ii (exploratory trials) and phase iii (clinical trials) rs 25,000 each for investigation of new drug. review of dossier under schedule y will require rs 25,000 for manufacture of new drug application and modified dosage claim and renewal of application rs 15,000 each, the statement added. the above changes in the laws governing the grant of permission for new drugs have been made with a view not only to streamline the examination of the application for introducing new drugs in the country in more scientific and rational way but also expediting their disposal. the controversy over illegal testing of the drug m4n, reportedly for a researcher at the johns hopkins university, at the regional cancer centre, trivandrum provides the backdrop to the current tightening of testing norms. reportedly, the drug was tested on 26 persons, without permission from the drug controller general of india. prior permission was mandatory only when the tested drug was sought to be marketed in india. this meant that drug companies or other researchers could carry out field trials in india without taking permission from indian authorities if they had no immediate plans to market the drug in india. now, this loophole has been closed.

Fresh mandatory norms for clinical testing of drugs

THE government on Tuesday announced amendments to the Drugs and Cosmetic Rules, 1945 to streamline procedures for manufacture and import of new drugs. As per the amended rules, no institution will be allowed to conduct clinical trials, whether for...

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