New regulations have promoted scientific and ethical research: Anupriya Patel

New Delhi, Oct 17 (PTI) The 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, Union Minister of State for Health Anupriya Patel said on Wednesday.

She made the remarks during her address at the 19th International Conference of Drug Regulatory Authorities (ICDRA) here on Wednesday.

"ICDRA is crucial in sharing knowledge, building partnerships, and working in harmonisation to ensure safe and effective medicines for everyone. How well we are doing in regulation - our efforts can lead to better health outcomes for people all over the world," Patel said.

The event, being hosted for the first time in India from October 14 to 18 by the Central Drugs Standard Control Organisation (CDSCO), Ministry of Health and Family Welfare, in collaboration with the World Health Organisation (WHO) brought together regulatory authorities, policymakers, and health officials from more than 200 countries.

Addressing the session, Patel emphasised on the new rules and regulatory procedures introduced in India.

She said, "The new regulations published in the areas of clinical trial as the 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 a robust pre-approval and post-approval regulatory procedures for all medical devices and diagnostics. "We are collaborating globally with international organisations such as the IMDRF, ISO, WHO and regional network like SEARN to harmonise regulatory requirements in the area of medical devices and diagnostics," she said.

The Union minister noted that India has been recently recognised as an affiliate member of the IMDRF.

"Recognition of Indian Pharmacopoeia by the Pharmacopoeial Discussion Group (PDG) is another milestone marking the harmonisation and recognition of regulatory standards," she added.

Patel highlighted the recently published revised Schedule M, aligned with the 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 said.

She further said, "AMR containment is another priority area in which India is building its strategy for effective management and control." On the government's commitment to healthcare, the Union minister said, "The focus is on building a strong healthcare system that meets the needs of our population. Programmes like Ayushman Bharat ensure that over 500 million people have access to quality healthcare. This shows our commitment to making healthcare a right for everyone, not just a privilege." PTI PLB MNK MNK