(a) whether the Government have decided to promote the development of drugs and vaccines and promote the test of medical products;
(b) if so, the details thereof;
(c) whether the Government have given its consent for testing of medicines and vaccines on animal;
(d) if so, the facts thereof;
(e) whether the Government have consulted the committee constituted for prevention of atrocities on animals in this regard; and
(f) if so, the details thereof?
MINISTER OF STATE IN THE MINISTRY OF SCIENCE AND TECHNOLOGY
( SHRI BACHI SINGH RAWAT)
(a) & (b) : Yes, the Department of Biotechnology (Govt. of India) has
specific programmes to develop diagnostics, improve/develop vaccines and
other biologicals. The Department of Science & Technology (Govt. of India)
has a programme on designing and developing new drugs for various diseases
and disorders. Recently, a National Jai Vigyan Science & Technology Mission
on development of new generation vaccines has been launched.
(c) to (f) : Preclinical toxicological data of any new drug/vaccines needs
to be generated in suitable animal species. This data is essentially
required as per the ` Drugs & Cosmetic` (8th Amendment) Rules-1988,
Ministry of Health & Family Welfare, Govt. of India, 1991 and without any
such data these drugs/vaccines can neither undergo clinical tirals in
humans nor can be used in human subjects and patients.
All the scientists/developers of products are aware of the existing
Govt. of India guidelines including the guidelines issued under the
`Prevention of the Cruelty to the Animals Act, 1960 and Breeding of and
Experiments on Animals (Control & Supervision)Rules, 1998.`
The bio-medical scientists have to obtain mandatory clearance from `
Institutional Animal Ethical Committee` duly approved by the Committee for
the Purpose of Controlling and Supervising Experiments on Animals (CPCSEA)
before carrying out any experiment on animals.
Recently, guidelines for experiment on animals have been revised and
scientists/institutes are strictly following these guidelines.