BCG VACCINE LABORATORY Vs. COMMITTEE FOR THE PURPOSE OF CONTROL AND SUPERVISION OF EXPERIMENT ON ANIMALS CPCSEA

JUDGEMENT

(1.) This writ petition has been filed by BCG Vaccine Laboratory against the Committee for the purpose of Control and Supervision of Experiment on Animals, hereinafter referred to CPCSEA . The petitioner and the respondent are organisations under the Central Government, the former under the Ministry of Health and Family Welfare, the latter under the Ministry of Social Justice and Empowerment. Prayer is for quashing the Letter No.CPCSEA/OrG/CH.2002/302 dated 30.1.2002, whereunder the expert consultant of CPCSEA has advised the petitioner to suspend all the animal experiments immediately.

(2.) The petitioner laboratory under the Directorate of Health Services has been established for manufacturing Freeze Dried BCG Vaccine for the control of childhood Tuberculosis and Tuberculosis Meningitis in children through the Expanded Programme of Immunizatiion, in short EPI, of the Government of India. The laboratory also functions as National Quality Control Laboratory for BCG Vaccine and g of imported BCG Vaccines. Laboratory has been established since May, 1948. BCG Vaccine produced in such laboratory is tested on guinea pigs, supposed to be the only animal susceptible to Tuberculosis. The Laboratory breeds guinea pigs for its use. If on testing sometimes sign of tuberculosis is traced, production is required to be stopped and the matter has to be intimated to the Ministry. The petitioner laboratory has been registered under Rule 5(a) of the Breeding of and Experiment of Animals (Control & Supervision) Rules, 1998 having Registration No.358.01.C/CPCSEA. The respondent Committee as apparent from the counter filed by the respondent, has been statutorily constituted by the Government of India in exercise of the power conferred under Section 17 of the Prevention of Cruelty to Animals Act, 1960 (hereinafter referred to as " PCA Act).

(3.) It is stated by the petitioner that on 5.2.2001, a nominee of the respondent Committee had visited the laboratory after due notice and had inspected the animals and the Animal House maintenance. It is asserted that the person who has visited the laboratory was satisfied with the entire process. It is further asserted that on 25.1.2002, one Sri. Badrinath, claiming to be the representative of the respondent Committee came to the laboratory without any prior notice and visited the Animal House and inspected the animals along with one staff employed in the laboratory. It is stated that he had orally instructed that a Veterinarian from the Institutional Animal Ethics Committee would have to inspect and issue a certificate about the health status of the animals which should be forwarded to the committee before 31.1.2002. It is further asserted that pursuant to the aforesaid advice, one Dr. Jayanthi Kannan Babu, Veterinarian of the Institutional Animal Ethics Committee visited the laboratory and the Animal House on 29.1.2002 and submitted a certificate dated 29.1.2002 indicating that the animals are maintained in good health. Such certificate was forwarded to the respondent. It appears that in the meantime, the Director of Laboratory, sent a letter to the Member Secretary of the respondent along with a copy to the respondent raising certain objections regarding the manner of inspection. The impugned letter is apparently a reply to such a letter of the Director. In the impugned letter, inter alia it is indicated that mortality rate of 25% is not acceptable and the petitioner was required to submit all details and also submit health monitoring report. In conclusion, it was indicated that