J P Nadda Emphasizes Global Standards in Drugs Regulation to Cement India's Position as "Pharmacy of the World"

Recognizing the integral role of state regulatory bodies in India's regulatory framework, Shri Nadda emphasized the necessity of collaboration to enhance their capabilities and ensure alignment with stringent quality standards set by the Central Government.

Union Health Minister Shri J P Nadda has articulated a strong vision for India to uphold its global reputation as the "Pharmacy of the World" by implementing a world-class regulatory framework for drugs, cosmetics, and medical devices. This declaration came during a comprehensive review session on drug regulation held today, attended by Union Health Secretary Shri Apurva Chandra, Drugs Controller General of India (DCGI) Dr. Rajeev Singh Raghuvanshi, and senior officials from the Central Drugs Standard Control Organization (CDSCO) and Union Health Ministry.

Highlighting India's pivotal role as a leading producer and exporter of pharmaceuticals globally, Shri J P Nadda stressed the imperative for CDSCO to develop a roadmap with clear timelines aimed at achieving international standards in all its mandated activities. He emphasized that this transformation should be system-based, focusing on the highest standards of uniformity, technical advancement, and future-oriented approaches. In particular, he underscored the necessity for robust systems to oversee the export of drugs and pharmaceuticals, ensuring stringent quality maintenance throughout.

Transparency emerged as a central theme in Shri Nadda's address, stressing, "In order to achieve global standards, our focus needs to be on transparency of procedures at CDSCO and within the drugs and medical devices industry." He emphasized that both regulatory bodies and industry stakeholders must uphold principles of transparency rigorously to ensure that products manufactured and sold by India meet the highest global quality benchmarks.

The Health Minister advocated for continuous dialogue between CDSCO and the drugs and medical devices industry to address challenges, understand issues, and support compliance with regulatory expectations. He emphasized the need for CDSCO to evolve into a user-friendly organization equipped with state-of-the-art facilities comparable to global standards to facilitate ease of doing business in the pharmaceutical sector.

Addressing concerns specific to the Micro, Small & Medium Enterprises (MSME) sector in drug manufacturing, Shri Nadda called for a supportive approach to help MSMEs enhance their capacity and product quality while navigating regulatory requirements effectively. He underscored the importance of empowering state drug regulatory bodies and aligning them with national standards, particularly in enhancing Good Manufacturing Practices (GMP) to meet global norms.

The Minister was briefed on CDSCO's current activities, achievements, future plans, and ongoing challenges, including the progress of the Scheme for strengthening state drug regulatory systems launched with a budget of Rs. 850 crores in 2016. Recognizing the integral role of state regulatory bodies in India's regulatory framework, Shri Nadda emphasized the necessity of collaboration to enhance their capabilities and ensure alignment with stringent quality standards set by the Central Government.