WHO inspectors along with drug control officials from other countries, held a comprehensive audit of the national regulatory authority (NRA) in India and gave a high score of 100, reversing its earlier adverse observations about the bad plight of regulatory system in the country two years ago.
"As many as 13 auditors from the WHO and other nations held a week-long audit in different aspects and carried out on-site inspections to assess the performance of the regulatory mechanism recently. We got a 100 score on all specific six indicators this time, whereas in the previous similar assessment held in late 2007, we had been given just around 40 score," DCGI Dr Surinder Singh told Pharmabiz.
The auditors inspected different areas like clinical trials, marketing licence authorisation, regulatory aspects and vaccine manufacturing during their stay in the country. The auditing teams inspected the Central Drugs Standard Control Organisation (CDSCO) in New Delhi and visited the Central Drug Laboratory, Kasauli, where the country's vaccine testing is done. The officials also carried out field inspections in some areas of Maharashtra where some time back four children died following the administration of measles vaccine. The auditors were drawn from the US food and drug administration, Belgium, France, Egypt, Thailand and the WHO headquarters in Geneva.
After the inspections in 2007, WHO made certain adverse remarks about the functioning of the Indian mechanism and the three public sector vaccine manufacturing units had suspended operations for the lack of WHO-GMP norms. No new applications for vaccines manufacturing was also granted since then after the WHO practically debarred the Indian vaccine manufacturers from WHO pre-qualification for supply to the UN agencies. "Now the WHO has already placed its observations and approval on its site for the public and new applications for the same can be approved and hence the exports will pick up," Dr Singh said.
After the WHO found deficiencies in the functioning of the Indian regulatory mechanism in 2007, it has launched extensive efforts to plug the loopholes and better the system by offering financial and technical assistance. The US FDA and Health Canada were thus roped in to guide and assist India in improving the system in all related aspects. A series of workshops and practical training both in Indian and abroad to the CDSCO staff were held, besides giving financial assistance for infrastructure. All the intense efforts, ably led by the DCGI for over a year, have finally found success now, observers feel.