Health Minister Nadda calls for world-class regulatory framework for India’s pharmaceutical industry

Health Minister Nadda calls for world-class regulatory framework for India’s pharmaceutical industry

Hummingbird News Desk

NEW DELHI, 17 JULY: Union Health Minister J P Nadda emphasized the need for India to develop a world-class regulatory framework to match its reputation as the ‘Pharmacy of the World’. Speaking at a high-level review meeting on the regulation of drugs, cosmetics, and medical devices, Mr. Nadda underscored the importance of upgrading the Central Drugs Standard Control Organization (CDSCO) to meet international standards.

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“India is the leading producer and exporter of drugs, and it is imperative that our regulatory framework matches our scale of operations and international expectations,” stated Mr. Nadda. He called on CDSCO to draft a roadmap with specific timelines to achieve global standards, focusing on uniformity, technical upgradation, and a forward-looking approach.

Highlighting the importance of maintaining the quality of drugs being exported, Mr. Nadda stressed the need for a systems-based approach. “For our export system, proper intervention is crucial to ensure the quality of drugs,” he emphasized.

Transparency within CDSCO and the broader industry was a key theme of Mr. Nadda’s address. He stated, “Our focus needs to be on transparency of procedures at CDSCO and within the drugs and medical devices industry. Both the regulatory body and the industry must adhere to the highest principles of transparency to ensure global quality standards.”

Mr. Nadda also underscored the importance of continuous dialogue between CDSCO and the drugs and medical devices industry. “Understanding their issues and supporting them to fulfill quality expectations and standards is essential. We should develop mechanisms that ensure ease of doing business for the industry while meeting regulatory requirements,” he stated.

Addressing the challenges faced by the Micro, Small & Medium Enterprises (MSME) sector in meeting quality standards, Mr. Nadda said, “Let us understand the issues faced by the MSME sector and support them to strengthen their capacity and quality of products. We must encourage them to meet regulatory requirements.”

The Union Health Minister was briefed on the activities, achievements, future plans, and challenges of CDSCO. He was updated on the progress of the Scheme for strengthening the state drug regulatory system, which was launched with a budget of Rs.850 crores in 2016 during his earlier tenure.

Mr. Nadda highlighted the roles and responsibilities of central and state drugs regulatory bodies, noting the challenges in aligning their efforts. “States are integral to our regulatory value chain. It is crucial to work in tandem with them to enhance their skills and capacities and encourage them to align with the quality standards of the Central Government,” he stated. This alignment is particularly important as CDSCO embarks on upgrading Good Manufacturing Practices to global standards.

The review meeting included Union Health Secretary Apurva Chandra, Drugs Controller General of India Dr. Rajeev Singh Raghuvanshi, and senior officers of CDSCO and the Union Health Ministry.

Tags: #JPNadda #UnionHealthMinister #Pharmaceutical

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