India needs to have world class regulatory framework to match ‘Pharmacy of the World’ reputation: Nadda

Union Health Minister JP Nadda on Wednesday said that India needs to have a world-class regulatory framework to match the country’s global reputation as ‘Pharmacy of the World’.

“For India to become the global leader in drug regulation to match our global reputation of ‘Pharmacy of the World’, we need to have a world-class regulatory framework matching our scale of operations and international expectations,” Nadda said. He was reviewing the regulation of drugs, cosmetics and medical devices.

Union Health Secretary Apurva Chandra, Drugs Controller General of India (DCGI) Rajeev Singh Raghuvanshi, and senior officers of the Central Drugs Standard Control Organisation (CDSCO) and Union Health Ministry were present at the high-level review meeting.

Highlighting the global position of India as the leading producer and exporter of drugs, Nadda stressed the need for CDSCO to draw a roadmap with timelines for achieving global standards in its mandated activities.

He stated that the upscaling needs to be systems-based, focusing on the highest standards of uniformity, technical upgrades, and futuristic approach. For export of drugs and pharmaceuticals, the system should be designed for proper intervention to maintain the quality of drugs being exported, he emphasized.

Nadda underscored the importance of transparency in the workings of CDSCO. He stated that “In order to achieve global standards, our focus needs to be on the transparency of procedures at CDCSO and within the drug and medical device industry.”. Both the Drugs Regulatory body and the industry should work on highest principles of transparency to ensure that the products manufactured and sold by India meet the highest indices of global quality standards, he said.

The Union Health Minister 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 to fulfill the quality expectations and standards of CDSCO. “Our focus should be on developing mechanisms that ensure easy of doing business for the drugs industry within the regulatory requirements. For this, CDSCO needs to be a user-friendly organization with state-of-the-art facilities matching global standards”, he stated.

On the topic of Micro, Small and Medium Enterprises (MSME) sector in drugs manufacturing and the issues faced by the small scale industries to meet quality standards, the Union Health Minister “Let us understand the issues faced by MSME sector and support them to strengthen their capacity and quality of products on the one hand, and encourage them to meet the regulatory requirements on the other.”

Shri Nadda was briefed about the mandated activities of CDSCO, its achievements, future plans and various issues and challenges faced by CDSCO. The Minister was also updated on the progress of the Scheme for strengthening state drug regulatory system with a budget of Rs.850 crores which was launched in 2016 during his earlier tenure.

The Union Minister was briefed on the roles and responsibilities of the central and state drugs regulatory bodies, and some of the challenges faced in alignment between them. Noting that the States are integral part of our regulatory value chain, Shri Nadda underscored the importance of working in tandem with the States so as to enhance their skills and capacities, and also encourage them to align with quality standards of the Central Government. “This is especially important in view of upgradation of Good Manufacturing Practices to global level embarked upon by CDSCO”, he added.