Indian pharmacopoeia standard used by 11 countries: DCGI Rajeev Raghuvanshi

Drugs Controller General of India (DCGI) Dr Rajeev Raghuvanshi has said that 11 countries in the world have already recognised Indian pharmacopoeia as their standard.

"India is supplying drugs, vaccines and medical devices to more than 200 countries world over; 11 countries in the world have already recognised Indian pharmacopoeia as their standard," he said.

"Now we are approving on an average, 100 global clinical trials every year for the last couple of years, and that shows the face of international research organizations and functional companies on the regulatory system which we are developing and developed till now, he added"

"On our part, India, Indian NRA, is reviewing and has approved the latest technology-based products like car T cell therapy, mRNA vaccine, software as medical devices, which shows that we are going through continuous upgradation of skills and capacity within our regulatory system. Recently, we notified six countries from where products of five designated categories are applied for approval in India," Raghuvanshi further said.

In October, the Ministry of Health and Family Welfare said that the Central Drugs Standard Control Organisation (CDSCO), along with the National Regulatory Authority of India (NRA) and affiliated institutions, has been found to meet international standards for vaccine regulations set by the World Health Organisation (WHO).

The WHO-led experts team approved India's vaccine regulatory system after an in-depth scientific review, conducted between September 16 and 20, as per a statement by the Ministry of Health and Family Welfare.

The 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 programmes of vaccines.

The WHO NRA re-benchmarking was aimed to assess and document the status of the Indian 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 measure the maturity of the system, the ministry said in the statement.

India has been declared 'functional' against all the core regulatory functions of the WHO Global Benchmarking Tool Version VI, the Ministry said.

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.