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What is the procedure for obtaining permission for manufacture of ” New Drugs” What is the role of State Drugs Controller in this respect?

April 26, 2017new drugs

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What is the procedure for obtaining permission for manufacture of ” New Drugs” What is the role of State Drugs Controller in this respect?

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New Drug clearance is given by Drugs Controller General (India) New Delhi. Therefore, you have to submit the application to Drugs Controller General (India), New Delhi for the permission/ clearance to manufacture ‘NEW DRUG”, as explained under Rule 122 E of the Drugs and Cosmetics Rules, 1945. After obtaining the permission from Drugs Controller General (India) New Delhi, you are required to submit the application to State Licensing Authority for the permission to manufacture.