New Delhi:Union HealthMinister JP Nadda on Wednesday said that India needs to have a world-class regulatory framework to become a global leader in drug regulation. “In order to achieve global regulatory standards, our focus should be on transparency of procedures at CDSCO and within the drugs and medical devices industry. It is also necessary to match our global reputation of 'Pharmacy of the World',” said Nadda.
Nadda was reviewing the regulation of drugs, cosmetics and medical devices here at a high-level meeting. Highlighting the global position of India as the leading producer and exporter of drugs, Nadda stressed on CDSCO to draw a roadmap with timelines of 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 upgradation 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 said.
Nadda underscored the importance of transparency in the working of CDSCO. “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 added.
Both the drug regulatory body and the industry should work on the highest principles of transparency to ensure that the products manufactured and sold by India meet the highest indices of global quality standards, he said.
Nadda said 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 quality expectations and standards of CDSCO.
"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," he asserted. Referring to the Micro, Small & Medium Enterprises (MSME) sector in the drugs manufacturing sector and the issues faced by them in meeting quality standards, Nadda said, "Let us understand the issues faced by the 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."
Nadda was also updated on the progress of schemes for strengthening the state drug regulatory system with a budget of Rs 850 crores which was launched in 2016 during his earlier tenure. 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 the quality standards of the Centre.
"This is especially important in view of the upgradation of Good Manufacturing Practices to global level embarked upon by CDSCO," he added. Union Health Secretary 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 were present for the meeting.
