In the run up to the World Health Organisation (WHO)’s National Regulatory Authority (NRA) Assessment of Vaccines in February 2017, a delegation of WHO is scheduled to visit India for conducting an observed audit in select vaccine manufacturing facilities from October 17 to 21, 2016 where observers from WHO shall assess the performance of the GMP inspectors of CDSCO and SLAs during the entire inspection process.
This will be a preparation visit which will decide the agenda of WHO delegation’s visit to be held in February next year. In February visit, WHO experts will take a final decision on whether National Regulatory Authority of India is capable to meet international standards for vaccine regulations.
“WHO will assess the overall capability of drug regulator that reflects how the vaccine manufacturers are being regulated in terms of safety, quality and effectiveness of vaccines produced in the country. The drug regulator is assessed for compliance against the revised WHO NRA indicators. In addition to the general framework for the system, the regulatory functions which will be evaluated include marketing authorization 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 authorization and monitoring of clinical trials. National drug regulator capability is assessed by WHO every three years and the last assessment happened in 2013. It is due in 2016,” said Drug Controller General of India (DCGI) Dr GN Singh.
In the run up to WHO delegation’s visit this month, DCGI held a meeting with vaccine manufacturers on September 26 to educate them about quality management system including post marketing surveillance, GMP, GLP compliance etc. The visiting WHO team will assess certificates issued to Indian vaccine manufacturers by CDSCO to meet International criteria of WHO.
Thirty representatives from vaccine manufacturers including Cadila Pharmaceuticals, Chiron Behring Vaccines, Haffkine Bio Pharmaceuticals, Panacea Biotec, Serum Institute of India, Bharat Biotech, Indian Immunologicals, Shantha (Sanofi) Biotechnics, GreenSignal Bio Pharma, Biological E Limited attended the meet.
If the WHO team concludes that the NRA for vaccines is functional, Indian vaccine manufacturers will become eligible to apply for prequalification status of their products. Prequalification status indicates that a vaccine meets international standards. Prequalification status is mandatory for vaccine manufacturers exporting their products to other nations through United Nations procuring agencies.