New Delhi. The Ministry of Health and Family Welfare announced that the Central Drug Standard Control Organization, CDSCO, has met safety, efficacy and quality guidelines for functional vaccines.
The announcement came after a comprehensive and in-depth review of Indian vaccine manufacturing by a team led by WHO that comprised of international experts from various countries. The Ministry of Health and Family Welfare
International experts from various countries who formed a part of the WHO team reviewed the Indian vaccine regulatory system from 16 September to 20 September.
The team assessed
National Regulatory Authority, NRA of India, the CDSCO
State drug regulatory authorities. Central drug laboratory at Kasauli.
Adverse events following immunization, AEFI structures at the central and state level
Immunization division
Pharmacovigilance program of India.
Other institutions in the regulation, control and testing of vaccines.
WHO plays a pivotal role in supporting countries in strengthening their regulatory systems and promoting equitable access to quality, safe applications and affordable medical products and health products. WHO representative to India Dr. Roderico H Ofrin.
WHO, with its global standards and benchmarks for assurance of vaccine quality through the development of tools and guidelines benchmarks, the national regulatory authority and the pre-qualification program of vaccines.
This re-benchmarking aims to assess.
The documents and status of the Indian regulatory system in vaccine regulation.
The status of the Indian vaccine regulatory system against the WHO NRA global benchmarking tool. GBT
To measure the system maturity.
Earlier in 2017, the WHO Global Benchmarking Tool, (GBT) version V was used. The GBT VI now used is more stringent.
India retains and flaunts Level 3 the highest status in several functions.
A major global vaccine producer and supplier to 150 countries, India has 36 vaccine manufacturing facilities.
The team that has just completed this assessment in India also drew a detailed institutional developmental plan to strengthen the vaccine manufacturing capacity of the country.
The WHO pre-qualification program (PQP) facilitates access to vaccines. Functional NRA is a prerequisite for manufacturers to supply vaccines to countries through United Nations procuring agencies.
(Input from various sources)
(Rehash/Swati Sharma/MSM)
