The Central Drugs Standard Control Organisation (CDSCO), along with the National Regulatory Authority of India (NRA) and affiliated institutions, has been found to meet the World Health Organization (WHO) published indicators for a functional vaccine regulatory system. This conclusion was reached by a team of international experts from various countries, led by WHO (HQ) in Geneva, following a comprehensive and in-depth scientific review of India’s vaccine regulatory system conducted from September 16 to 20, 2024.
Safety, efficacy, and quality are three basic parameters of assessment of vaccines. WHO has established global standards and benchmarks for assurance of vaccine quality through the development of tools and guidelines, benchmarking of the NRA and prequalification programme of vaccines.
The WHO NRA re-benchmarking was aimed to assess and document the status of the India regulatory system in the area of vaccine regulation, re-benchmark the status of the India vaccine regulatory system against the WHO NRA Global Benchmarking Tool (GBT) and measuring the maturity of the system. India has been declared ‘functional’ against all the core regulatory functions of the WHO Global Benchmarking Tool Version VI. India’s vaccine regulatory system was benchmarked in the year 2017 against Global benchmarking tool (GBT) version V which is now revised to GBT VI with raised bars and stringency in benchmarking criteria.
India retains Maturity Level 3 with highest marks in several functions.
Speaking about this landmark achievement, 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, as a 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).
Welcoming the positive outcome of international benchmarking, Dr Alireza Khadem, WHO Team Leader for the NRA Re-benchmarking, said, “It will go a long way in re-affirming India’s role in global health, including the strength of its pharmaceutical sector and drug regulatory capacity. WHO had scaled up its technical support to the India’s national regulatory authority over the past several years. This success is a culmination of intensive effort by the Health Ministry, including CDSCO, in collaboration with WHO, to implement a roadmap to strengthen capacity for regulation of vaccines,”.
India is a major vaccine producer that has 36 major vaccine manufacturing facilities. These vaccines are used for the national and international market (150 countries), which makes India a major vaccine supplier across the globe.
The WHO Prequalification Programme (PQP) is aimed at facilitating access to vaccines that meet unified standards of quality, safety and efficacy as well as programme needs. It is also prerequisite for manufacturers to supply to countries through United Nations procuring agencies. A functional NRA is a criterion for WHO prequalification of vaccines.
As for all NRA benchmarking, sustainability of the gains made in regulatory capacity is critical. For this purpose, the team which has just completed the assessment in India has drawn up a detailed Institutional Development Plan. The plan will outline additional activities to be undertaken to further strengthen regulatory capacity in India in the coming years.
World Health Organization carried out assessment of the National Regulatory Authority (NRA) of India comprising the Central Drugs Standard Control Organisation (CDSCO), State Drug Regulatory Authorities, Central Drugs Laboratory, Kasauli; Adverse Events Following Immunization (AEFI) structures at the Central and States levels, Immunization Division, Pharmacovigilance Programme of India, and other relevant institutions engaged in the regulation, control and testing of vaccines.
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