The World Health Organisation (WHO) has endorsed the Central Drugs Standard Control Organisation (CDSCO)'s regulatory works and cleared the functional vaccine regulatory system in the country, after a thorough inspection involving experts from eight other countries.

“A WHO-led team concluded after a comprehensive review by experts from eight countries, that the National Regulatory Authority of India, and affiliated institutions, met WHO published indicators for a functional vaccine regulatory system,” an official statement said.

Effective regulatory oversight of vaccines is essential since vaccines are used on a population-wide basis, and are usually given to healthy infants. Furthermore, vaccines are produced in only a small number of countries and often exported from the country of manufacture to many countries. India is a major vaccine producer that has 12 major vaccine manufacturing facilities. These vaccines are used for the national and international market (150 countries) which makes India a major vaccine supplier. In 2012, India had seven vaccine manufacturers producing 67 pre-qualified vaccines (dosage forms), however during 2012 the WHO has suspended the vaccine pre-qualification status for nine vaccines (dosage forms) from three vaccine manufacturers, it said.

One of the requirements to become eligible and retain the pre-qualification status is to have a National Regulatory Authority (NRA) assessed as functional against the WHO published NRA indicators. Countries importing vaccines need to be confident that the national regulatory authority in the country of origin is competent in its oversight.

“WHO has established benchmarks that define international expectations for a functional vaccine regulatory system. WHO also conducts regular external audits of national regulatory authorities, particularly in vaccine-producing countries, to ensure that the regulatory systems meet the necessary standards, and that the system is maintained and functions in a sustainable way,” it said.

“The regulatory functions of the Central Drugs Standards Control Organisation and its affiliated institutions were assessed for compliance against the WHO indicators. In addition to the general framework for the system, the following regulatory functions were evaluated: marketing authorisation and licensing; post-marketing surveillance, including for adverse events following immunization; lot release by the national regulatory authority; laboratory access; regulatory inspections of manufacturing sites and distribution channels; and authorisation and monitoring of clinical trials,” as per the official statement.