Union Minister Smt. Patel emphasized on the new rules and regulatory procedures introduced in India. She said, “new regulations published in the areas of clinical trial as New Drugs and Clinical Trial rules 2019 and Medical Device Rules 2017 have promoted scientific and ethical research at par with global expectation and international practices.
The medical device rules include risk-based classification, bringing all devices under regulation through registration and framing regulatory pathway.” She further stated that “there is robust pre-approval and post approval regulatory procedures of all medical devices, diagnostics managing product lifecycle indicating robust control.
We are collaborating globally with international organizations such as IMDRF, ISO, WHO and regional network like SEARN to harmonise regulatory requirements in the area of medical devices and diagnostics.”
The Union Minister noted that India has been recently recognised as an affiliate member of IMDRF. “Recognition of Indian Pharmacopoeia by the Pharmacopoeial Discussion Group (PDG) is another milestone marking the harmonisation and recognition of regulatory standards”, she added.
Smt. Patel highlighted that the recently published revised Schedule M,aligned with WHO requirements of good manufacturing practices for various products including biologicals, investigational products,further establish the harmonisation goal. “This coupled with
e-governance for all regulatory procedures have established good regulatory practices in the regulation of medical products in India”.
She also informed that “AMR containment is another priority area in which India is building its strategy for effective management and control.”
