Regulatory Strategy in India

Regulatory Strategy for Medical Devices in India
Regulatory Strategy for Pharmaceuticals/Drugs in India

Indian medical regulations are lax in some areas and strict in others. Regulatory responsibilities for medical products are divided between the Drugs Controller General India (DCGI) and the 35 drug controllers at the state level of government. The DCGI oversees new drugs, imported drugs, and some medical devices, but the state drug controllers also play an important role.

Registering foreign drugs with the DCGI can take time. Strategies to shorten the wait include working to keep your product from being classified as a "new drug." It can also be helpful to seek support for your product from Indian institutions such as top-tier government hospitals.

The regulatory environment for medical devices in India is new and still changing rapidly. In the past, almost no medical devices required registration before marketing. Since 2005, however, a number of medical devices need product registration.

Manufacturing medical products in India requires compliance with local quality standards. India's relevant manufacturing standards are outlined in Schedule M for drugs and Schedule M-III for medical devices.

PBM's regulatory experts can help your company determine the most cost-effective and time-efficient regulatory strategy for India.

For more information on regulatory issues in India, please see the following PBM publications and/or contact us to discuss your specific needs.

Back to Top