India Seeks Input on Draft Revisions to Device GMPs
Posted 04 December 2014 | By
This content is provided by RegLink News, publishers of e-weekly global regulatory news. RegLink offers a 30-day free trial and 15% discount on Global Update subscriptions to RAPS members.
India’s Central Drugs Standard Control Organization (CDSCO) is seeking input on draft revisions to Schedule M-III of the country’s Drug and Cosmetic Act, which describes good manufacturing practices (GMPs) for medical devices.
The revisions aim to bring the GMP requirements for medical devices and in-vitro diagnostics into alignment with international GMP standards. They require that the quality system for the manufacture of devices and IVDs conform to the BIS 15579/ISO 13485 international standard, an internationally recognized quality standard which states the requirements of the quality management system for the design and manufacture of medical devices.
For combination devices, the manufacturing process for the drug/biologics must conform to the GMP requirements set out in Schedule M of India’s Drug and Cosmetic Act governing pharmaceutical GMPs, but the process of loading the drug/biologics into the device and thereafter will be governed by the proposed device/IVD GMP standards.
The deadline for comments on the draft GMPs is 17 December 2014.