Question : VACCINE AGAINST JAPANESE ENCEPHALITIS

(a) the present status of implementation of the vaccination campaign against Japanese Encephalitis (JE) and the extent of success achieved in bringing down the number of cases of JE in the country, State/ UT-wise;

(b) whether India has recently developed an indigenous vaccine against JE using the Indian strain of virus;

(c) if so, the details thereof indicating the present status of its development and the time by which the said vaccine is likely to be introduced in public health programme in the country;

(d) whether certain countries have requested the Government to share the information about the development of the said indigenous vaccine; and

(e) if so, the details thereof?

THE MINISTER OF HEALTH AND FAMILY WELFARE (SHRI GHULAM NABI AZAD)

(a)to(e): A statement is laid on the Table of the House.

STATEMENT REFERRED TO IN REPLY TO LOK SABHA STARRED QUESTION NO.12 FOR 22.2.2013

(a) Japanese Encephalitis (JE) vaccination campaign was started from 2006 onwards. Till date, approximately 8 crore children from 15 States have been vaccinated. Details are at Annexure –I.

The details of reported JE Cases from 2008 onwards for the said 15 States are at Annexure II.

(b)&(c) An Indian manufacturer, i.e. Bharat Biotech, has developed an inactivated, vero cell culture derived adjuvenated liquid vaccine. The virus strain used for this vaccine is an Indian strain isolated from a patient in a JE endemic zone in Kolar, Karnataka by the National Institute of Virology, Pune and transferred to Bharat Biotech through a material transfer agreement. Phase 3 clinical trial of this vaccine has been carried out in India. The Manufacturing permission of inactivated Japanese Encephalitis vaccine under Rule 122B of Drugs & Cosmetics Rules has been granted to M/s Bharat Biotech Ltd by the Drug Controller General of India (DCGI) on 06.07.2012; however, the manufacturing licence in Form 28D for said vaccine has not been granted due to some regulatory requirements as per the Drugs & Cosmetics Rules.

(d)&(e) No such request has been received by the Ministry of Health & Family Welfare from any country.