Regulatory Focus™ > News Articles > India's CDSCO Orders Local Authorities to Adhere to Drug Regulations

India's CDSCO Orders Local Authorities to Adhere to Drug Regulations

Posted 15 October 2012 | By Ansis Helmanis 

India's Central Drugs Standard Control Organization (CDSCO) issued directions to local authorities on 12 October 2012 to comply with the requirements of the national Drugs and Cosmetics Act concerning the grant of licenses for new and generic drugs. 

For generic drugs, local authorities were told that licenses can only be granted for generics under the generic name of the formulation, In the case of formulations containing multiple ingredients, the license should be granted under the name of product category (such as multivitamin tablets/capsules/syrup, antioxidants) and must specify the names of each active ingredient as well as dosage strength. 

For new drugs, local authorities were reminded that they cannot issues licenses without prior approval of the national licensing authority, the CDSCO. In its 59th report on the CDSCO, the Parliamentary Standing Committee on Health and Public Welfare objected to the lack of compliance with this requirement by local authorities.


Read more:

Read all Breaking News from RegLinks


Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe