Vaccine industry gains confidence, aims global leadership

Grappling with messy regulations in the past, the formation of core groups on vaccine regulations is seen as a strategic move by the regulator and yet offers a business friendly environment to the industry


As per an industry source, the vaccine manufacturers were satisfied with the proceedings and outcome of meeting as the action started there and then.

For the purpose of charting out a new regulatory pathway for vaccines, the Central Drugs Standard Control Organization (CDSCO) has constituted three core working groups from within the industry. One each for strategy, technical operations and technical post approval each with its designated chairman and member secretary who will take the things forward in a time bound manner. The new initiative is an outcome of the interaction between the vaccine manufacturers and importers in the country with the Drug Controller General of India (DCGI) on January 15, 2015 at the FDA Bhawan, in New Delhi.

The meeting was convened to hold discussions on the current national and international scenarios in vaccine development and its regulations. The dialogue between regulator and industry on various issues, challenges, opportunities in respect of manufacturing of priority vaccines including import of vaccines and regulatory pathways i.e to promote a legal, regulatory and administrative framework for the safety of vaccines at national and international levels.

With a great potential to emerge as country's key industrial contributor, the vaccine businesses have not been fully able to evolve due to regulatory hiccups. With the takeover of the new government and Mr Modi's promise of making the business hassles free, the health ministry too is trying to streamline the regulations. India already 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 across the globe. In 2012, India had seven vaccine manufacturers producing 67 prequalified vaccines (dosage forms). Currently 16 vaccines are prequalified by WHO and exported through United Nations agencies. More than 70 percent of all measles vaccines used globally are produced in India.

Playing the big role globally

Talking about the meeting, Mr R K Suri, Chief Executive-Biologicals, Panacea Biotec, mentioned, "It was indeed a new chapter on the anvil in the Indian regulatory space where the regulatory team under the able leadership of the DCGI, Dr GN Singh was clearly eager to translate the vision of our prime minister, Mr Narendra Modi to take India on the leadership level in the Vaccine map of the world in next 5-6 years."


Previous 1 3 Next

Leave a Reply Sign in

Notify me of follow-up comments via e-mail address

Post Comment

Survey Box


GST: Boon or Bane for Healthcare?

Send this article by email