India Releases Comprehensive Draft Regulations

On July 8, the Indian government issued new legislation to get shareholders’ feedback. This legislation started in 2016 and is trying to replace the Drugs and Cosmetics Rules of 1945. New definitions for investigational new drugs, medical devices, clinical trials, etc. were included. New severe penalties for clinical trials that lead to serious injuries or deaths are described. In addition, the Drugs Control Officer shall have the right to go on-site during clinical trials and examine all records. Medical products are not permitted to be sold online unless explicit permission is granted. Also suggested is setting up advisory boards for both devices and drugs to help the government with sensitive issues that come up.

Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.

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