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Honourable Dr. G. N. Singh, Drug Controller General of India presented a Momento by our Director Mr. Syed S. Abbas & Principal Advisor Mr. Vinod Arora on the launch of our Computer System Validation (CSV) programme

IGMPI is conferred with ASSOCHAM Services Excellence Award 2017: Our Directors Mr Syed S. Abbas & Mrs Rafat Abedi, Chief Advisor Dr Mahesh Gupta, Advisor Mr Amitabh Srivastava are being honoured by the Chief Guest & Honorable Member of Parliament Dr. Udit Raj


Finalization of clinical trial rules within few months by CDSCO

Finalization of clinical trial rules within few months by CDSCO

India is a country with almost 1.2 billion population consisting of large burden of diseases, hence considered to be a place with attractive patient pool for global pharmaceutical companies looking for testing new drugs. However some of the pharma companies have moved to other countries in the last few years for doing research due to strict rules.

CDSCO is thereby planning to finalize the new rules in a couple of months which aims to reduce the approval time for review of applications to between 30 days and 60 days. According to Ranga Chandrasekhar, a deputy drugs controller at the CDSCO, “The new rules would shorten the review time thereby boosting clinical research in the country in the recent times. According to the new rules, ‘ethics committees’- group of medical experts would decide the level of compensation for the patients suffering adverse events. CDSCO is also planning to bring in new rules for the sale of over-the-counter drugs, and e-pharmacies in the coming months.
According to D.G. Shah (Secretary general of the Indian Pharmaceutical Alliance), “Strict compensation rules could lead to companies conducting clinical research outside India who otherwise have been gradually looking back to India for clinical work. There has been some revival of clinical research based on assurances given by the government for simplification of rules however if the compensation rules are adopted as given in the draft released by CDSCO then companies will run away from India and this is not conducive to doing innovation and research in India.”

The draft rules were uploaded on CDSCO’s website in the month of February and if finalized it would be circulated to health ministry for approval before being published.