Friday, 4 March 2022

BCG Vaccine Laboratory Vs Committee for the purpose of Control and Supervision of Experiment on animals

 Vande Matram friends! Welcome to the series on Animal Welfare in India. I am feeling proud of myself for presenting this series in front of you and I pray to Thy Almighty that I can share a maximum of information in this regard with you!

Those who want justice must knock the doors of Courts!

Introduction:

In this Article, you will know about a judgment of the Madras High Court in regards to experiments on animals. This judgment was decided on 30 April, 2003. This case was decided by Justice P K Misra.

Reference no.: WRIT PETITION No.3189 OF 2002 AND WPMP.NO.4488 OF 2002

Petitioner was BCG Vaccine Laboratory, Chennai 32 through its Director.

Respondent was Committee for the Purpose of Control and Supervision of Experiment on Animals (CPCSEA), Animal Welfare and Division, Ministry of Social Justice and Empowerment, No.3, Seaward Road, Valmiki Nagar, Tiruvanmiyur, Chennai 600 041.  (Note this address for any grievance related to experiments on animals in the State of Tamil Nadu.

Petition filed under Article 226 of the Constitution of India for issuance of a Writ of Certiorarified Mandamus.

Facts of the case:

Petitioner BCG Vaccine Laboratory filed this petition for quashing the letter issued by respondent Control and Supervision of Experiment on Animals (CPCSEA) whereunder the expert consultant of CPCSEA has advised the petitioner to suspend all the animal experiments immediately.

The petitioner is a laboratory under the Directorate of Health Services and it 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 Immunisation (EPI), of the Government of India. Petitioner functions as National Quality Control Laboratory for BCG Vaccine manufactured in India as well as imported. The laboratory has been established in May, 1948.

BCG Vaccine 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 a 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.

The respondent Committee has been statutorily constituted by the Government of India in the exercise of the power conferred under Section 17 of the Prevention of Cruelty to Animals Act, 1960 (PCAA).

Dt. 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. The nominee of the respondent was satisfied with the entire process.

Dt. 25.1.2002: one Sri. B, 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 (IAEC) 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.

Dt. 29.1.2002: one Dr. JKB, Veterinarian of the IAEC visited the laboratory and the Animal House and submitted a certificate Dt. 29.1.2002 indicating that the animals are maintained in good health. Such a certificate was forwarded to the respondent.

The Director of petitioner 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.

In the reply letter from the respondent, it is indicated that a mortality rate of 25% is not acceptable and the petitioner was required to submit all details and also submit a health monitoring report. In conclusion, it was indicated that “ You are advised to immediately suspend all animal experiments, screen the animals, and submit a health certificate from the appropriate authority.”

As already indicated the prayer in the writ petition is to quash the same. Further prayer is for a direction to the respondent to depute any qualified Veterinarian from the approved Government Agency to examine the guinea pigs for the purpose of ensuring viral and bacterial infections as quoted by the respondent.

Prevention of Cruelty to Animals Act, 1960

Section 14 provides:

Nothing contained in this Act shall render unlawful the performance of experiments (including experiments involving operations) on animals for the purpose of advancement by new discovery of physiological knowledge or of knowledge which will be useful for saving or for prolonging life or alleviating suffering or for combating any disease, whether of human beings, animals or plants.

A perusal of Section 14 thus makes it clear that testing which is carried on by the petitioner is not prohibited.

Section 15(1) provides for constituting a Committee for the purpose of controlling and supervising experiments on animals. As a matter of fact, the respondent Committee has been so constituted.

Section 15A empowers the Committee to constitute as many as Sub-committees as it thinks fit for exercising any power or discharging any duty of the Committee or for inquiring into or reporting and advising on any matter which the Committee may refer.

Section 17 relates to the duties of the Committee and the power of the Committee to make rules relating to experiments on animals.

Section 17(1) is to the following effect:

It shall be the duty of the committee to take all such measures as may be necessary to ensure that animals are not subjected to unnecessary pain or suffering before, during or after the performance of experiments on them, and for that purpose it may, by notification in the Gazette of India and subject to the condition of previous publication, make such rules as it may think fit in relation to the conduct of such experiments.

Section 17(1A) is the rulemaking power and it is extracted hereunder:

In particular, and without prejudice to the generality of the foregoing power, such rules may provide for the following matters namely:-

(a) the registration of persons or institutions carrying on experiments on animals;

(b) the reports and other information which shall be forwarded to the Committee by persons and institutions carrying on experiments on animals.

From the aforesaid provisions, it is apparent that the committee has the jurisdiction to take measures to ensure that the animals are not subjected to unnecessary pain. The Rules can be framed regarding carrying on experiments.

Section 19 relates to the power to prohibit experiments on animals and it is extracted hereunder:

If the Committee is satisfied, on the report of any officer or other person made to it as a result of any inspection under section 18 or otherwise, that the rules made by it under section 17 are not being animals, the Committee may, after giving an opportunity to the person or institution carrying on experiments on animals; the Committee may, after giving an opportunity to the person or institution of being heard in the matter, by order, prohibit the person or institution from carrying on any such experiments either for a specified period or indefinitely, or may allow the person or institution to carry on such experiments subject to such special conditions as the Committee may think fit to impose.

A perusal of the aforesaid provision makes it clear that the Committee can prohibit a person or institution to carry on any such experiments, such one to a specific period or indefinitely. The Committee may also allow the person or institution to carry on experiments subject to special conditions as the Committee may think fit to impose.

Section 20 provides for penalties and it is extracted hereunder:

If any person-

(a) contravenes any order made by the Committee under section 19; or

(b) commits a breach of any condition imposed by the Committee under that section:

he shall be punishable with fine which may extend to two hundred rupees, and, when the contravention or breach of condition has taken place in any institution the person in charge of the institution shall be deemed to be guilty of the offence and shall be punishable accordingly.

Interpretation of statute:

Before giving verdict Court interpreted the provisions of PCAA in the following manner. The Court's interpretation is reproduced here as it is from the original judgment:

Section 19 itself envisages that prohibition can be for a specified period or indefinitely. In the present case, the letter simply says that the petitioner is required to suspend all animal experiments. Apparently this would amount to prohibition for an indefinite period. Whether the prohibition is for a specified period or unspecified period, it is necessary that before issuing such direction, opportunity must be given to the person or the institution concerned. This is apparent from the provisions contained in Section 19 itself. In the present case, it is not disputed that before issuing the impugned order no opportunity has been given to the petitioner. It is of course true that the impugned letter has been issued pursuant to a letter written by the Director himself of the petitioner laboratory, but that does not mean that an opportunity had been given as contemplated under Section 19. On this ground alone, the impugned letter is liable to be quashed.

Apart from the above, it is apparent that the direction is to be issued by the Committee. In the present case, the letter, even though in the official pad of CPCSEA, has been signed and sent by expert consultant of CPCSEA, Chennai. By no stretch of imagination it can be said that the expert consultant of CPCSEA has authority to take any decision on behalf of the Committee. Even though such an expert may be a member of such Committee, the decision is to be taken and the direction is to be given by the Committee. It is of course true that the Committee has power to form Sub-committees and even a single member may be a Sub-committee, but the power under Section 19 can be exercised only by the Committee and not by any Subcommittee or any individual being a member of the Committee or the Sub-committee. Examined in the light of the aforesaid aspect, it is obvious that the letter issued to the petitioner cannot be construed as a direction contemplated under Section 19 of the Act.

The petitioner has also raised objections regarding the manner of inspection. Section 18 contains the power of entry and inspection and it is quoted hereunder:

For the purpose of ensuring that the rules made by it are being complied with the Committee may authorise any of its officers or any other person in writing to inspect any institution or place where experiments are being carried on and report to it as a result of such inspection, and any officer or person so authorised may

(a) enter at any time considered reasonable by him and inspect any institution or place in which experiments on animals are being carried on; and

(b) require any person to produce any record kept by him with respect to experiments on animals.

It suffices to say, that in future any occasion arises for inspection, the provisions contained in Section 18 should be kept in view and only a person authorised in writing by the Committee can inspect any institution or place where an experiment is carried on.

For the aforesaid reasons, the writ petition is allowed. No costs. However, it is made clear that the order passed in the present writ petition would not stand in the way of the respondent in taking any action in accordance with law as contemplated in the Prevention of Cruelty to Animals Act, 1960.

Thus this was the case, in which though the committee was having the power to authorise any person in writing for the inspection of any organisation where experiments on animals are carried out. But based on the inspection report only one person can not pass any order on behalf of the committee though he may be a member of that committee. Also, a fair chance was not given to the petitioner by the respondent to put the opinion of the petitioner in this matter, which was necessary to pass an order of suspension of experiments carried on animals. The PCCA does not ban experiments on animals. Thus the lacunas in the procedure committed by the respondent were the reason for quashing the order passed by the respondent.

Note: Part in Red is reproduced as it is from the Bare Act. This is not the complete judgment. This article is intended for knowledge purposes only. Click here for complete judgment.

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