Need to have world class regulatory framework, says Nadda at review meeting

Union Health Minister J P Nadda on Wednesday asked officials to stress the need to develop world-class regulatory systems and ensure transparency of procedures at a high-level review meeting on regulations for drugs and cosmetics.

“For India to match our global reputation as the ‘Pharmacy of the World’, we need to have a world-class regulatory framework that matches our scale of operations and international expectations,” Nadda said in the meeting.

Speaking on the need for transparent regulatory procedures, Nadda said that both the industry and the drug regulatory bodies should work with the highest principles of transparency to ensure that the products manufactured and sold by India meet the highest indices of global quality standards.

The Central Drug Standards Control Organisation (CDSCO) has been asked to draw a roadmap with timelines for achieving global standards in its mandated activities.

The minister added that upscaling to good manufacturing practices (GMP) needs to be systems-based, focusing on the highest standards of uniformity, technical upgradation, and a futuristic approach.

This comes as the government started working on the proper implementation of the revised Schedule M, which includes GMP guidelines to ensure the manufacturing of quality drugs.

Some of the major changes introduced in the revised Schedule M include the introduction of a pharmaceutical quality system (PQS), quality risk management (QRM), product quality review (PQR), qualification and validation of equipment, and a computerised storage system for all drug products.

Nadda also stated that it is important for CDSCO to be in continuous dialogue with the drugs and medical devices industry to understand their issues and support them in fulfilling the expectations of quality standards.

“Our focus should be on developing mechanisms that ensure ease of doing business for the drugs industry within the regulatory requirements. For this, CDSCO needs to be a user-friendly organisation with state-of-the-art facilities matching global standards,” Nadda stated in the meeting.

Noting that the states are an integral part of the regulatory value chain, Nadda asked officials to work in tandem with the state regulatory bodies to enhance their skills and capacities and also encourage them to align with the quality standards of the central government.