In a major boost to the country’s private vaccine manufacturing pharmaceutical companies, the World Health Organisation (WHO) has said that India’s national regulatory authority — Central Drugs Standard Control Organisation (CDSCO) — and its affiliated institutions meet the prescribed international standards.
India is a major vaccine producer with 12 major vaccine manufacturing facilities. These vaccines are used for the national and international market, reaching nearly 150 countries. Every second child in the world is vaccinated for measles using a vaccine produced in India.
India is the first country in 2012 to have passed the strict levels of seven indicators which are made more stringent every time in a single round of assessment which is done by a team of 12 international experts headed by a WHO member.
Passing of this test means that 12 private vaccine manufacturing units from India are eligible and retain the pre-qualification status for supplying vaccines to international bodies like the WHO, UNICEF and the World Bank. WHO pre-qualification is a guarantee that a specific vaccine meets international standards of quality, safety and efficacy.
The clearance by the WHO is expected to boost investment in the pharmaceutical sector and push exports higher, which touched $13 billion last year and is expected to touch $26 billion this year. Two-thirds of the vaccines produced in India are exported.
The WHO has established benchmarks that define international expectations for a functional vaccine regulatory system. It also conducts regular external audits of national regulatory systems and ensures they meet the necessary standards. The regulatory functions of India’s National Regulatory Authority (NRA) — the CDSCO — and its affiliated institutions were assessed for compliance against the WHO indicators and marketing authorisation and licensing, post-marketing surveillance, including adverse events following immunisation and so on.
In 2007, when the CDSCO had failed to meet the WHO-prescribed standards, it had led to the WHO suspending manufacturing licenses of three public sector vaccine manufacturing units on account of non-compliance of good manufacturing practices (GMP) norms. India had made up for the deficiency in the 2009 assessment and the units were re-started.
