Ms. Punya Salila Srivastava, Union Health Secretary, stated, “The Central Drugs Standards Control Organization, in collaboration with WHO, has made exemplary efforts towards this achievement. India is one of the main players in the pharmaceutical industry worldwide and is known for its affordable vaccines and generic medicines.”
She also congratulated all the teams for their hard work in achieving this milestone for the country and reemphasized the strength of the Indian regulatory system and its commitment to supplying quality products worldwide to enhance health outcomes.
Dr Roderico H. Ofrin, WHO Representative to India noted, “The WHO plays a pivotal role in supporting countries in strengthening their regulatory systems, and promoting equitable access to quality, safe,efficacious, and affordable medical products and health products.
This is indeed a great achievement, and we would like to congratulate the Ministry of Health & Family Welfare and its affiliated institutions,” he added.
Dr Rajeev Singh Raghuvanshi, Drugs Controller General (India), Central Drugs Standard Control Organization, MoHFW highlighted that “India, asa large vaccine producing country, is currently supplying several vaccines to the UN agencies (UNICEF, WHO and PAHO)”. “National Regulatory Authority of India meets the standards of the WHO NRA indicators (WHO Global benchmarking Tool) on functional regulatory system for vaccines” he added.
In addition to the general framework for the system, the following regulatory functions were evaluated: General Overview of the National Regulatory System (RS), Registration and Marketing Authorization (MA),Vigilance (VL), Market Surveillance and Control (MSC), Licensing Establishments (LI), Regulatory Inspections (RI), Laboratory Testing (LT), Clinical Trials Oversight (CT) and NRA Lot Release (LR).
