2017 (4) TMI 927 - SC - Indian Laws

Parliamentary Standing Committee - can be referred before court in a proceeding or not - Whether before the drug was accepted to be used as a vaccine in India, the Drugs Controller General of India and the ICMR had followed the procedure for said introduction? - Held that - Parliamentary Standing Committee report may not be tendered as a document to augment the stance on the factual score that a particular activity is unacceptable or erroneous. However, regard being had to the substantial question of law relating to interpretation of the Constitution involved, we think it appropriate that the issue be referred to the Constitution Bench under Article 145(3) of the Constitution. We frame the following questions for the purpose of reference to the Constitution Bench - (i) Whether in a litigation filed before this Court either under Article 32 or Article 136 of the Constitution of India, the Court can refer to and place reliance upon the report of the Parliamentary Standing Committee? (ii) Whether such a Report can be looked at for the purpose of reference and, if so, can there be restrictions for the purpose of reference regard being had to the concept of parliamentary privilege and the delicate balance between the constitutional institutions that Articles 105, 121 and 122 of the Constitution conceive?

Issues Involved:

1. Procedure followed by the Drugs Controller General of India and ICMR for the approval of the HPV vaccine.
2. Actions taken post the submission of the 72nd Parliamentary Committee report.
3. Selection criteria for vaccination sites in Gujarat and Andhra Pradesh.
4. Causes of deaths and ailments post-vaccination.
5. Monitoring steps taken by competent authorities for the vaccine.
6. Consent obtained from parents/guardians of the vaccinated girls.
7. Protocols required for vaccination.

Detailed Analysis:

1. Procedure Followed by the Drugs Controller General of India and ICMR:
The court examined whether the Drugs Controller General of India and ICMR followed the proper procedures before approving the HPV vaccine for use in India. The court directed the Union of India to produce the file by which the vaccine was approved, ensuring transparency in the approval process.

2. Actions Post 72nd Parliamentary Committee Report:
The court inquired about the actions taken after the Parliamentary Committee submitted its 72nd report on August 30, 2013. The Union of India and the State of Gujarat filed affidavits detailing the safety measures and steps undertaken to address the concerns raised in the report, emphasizing the necessity of the vaccine and improvements made in the trial methods.

3. Selection Criteria for Vaccination Sites:
The reasons for choosing specific locations in Gujarat and Andhra Pradesh for the vaccination program were scrutinized. The court sought clarity on the selection process and the rationale behind it, ensuring that the sites were chosen based on appropriate criteria.

4. Causes of Deaths and Ailments Post-Vaccination:
The court investigated the actual causes of deaths and other ailments in individuals who had been administered the vaccine. The focus was on determining whether the vaccine was directly responsible for these adverse effects and if proper measures were in place to address such incidents.

5. Monitoring Steps by Competent Authorities:
Given the nature of the HPV vaccine, the court examined the steps taken by the Union of India and State Governments to monitor the vaccine's administration and its effects. Affidavits were filed detailing the monitoring mechanisms and safety protocols implemented to ensure the vaccine's safe usage.

6. Consent from Parents/Guardians:
The court considered whether proper consent was obtained from the parents/guardians of the vaccinated girls, as many of them had not reached the age of majority. The concept of consent was a significant issue, and the court issued directions for filing affidavits to ensure that consent protocols were followed.

7. Protocols for Vaccination:
The court sought to understand the protocols required for carrying out such vaccinations, emphasizing the need for a standardized approach to ensure safety and efficacy. The court directed the Union of India to provide relevant documents and protocols followed during the vaccination process.

Judicial Review of Parliamentary Standing Committee Reports:
A significant issue raised was whether the court could refer to and rely on the report of the Parliamentary Standing Committee in a public interest litigation under Article 32. The learned Attorney General and other senior counsel argued that such reports are meant for guiding the functioning of departments and not for use in court proceedings. The court deliberated on the constitutional parameters and the doctrine of restraint, considering the implications of judicial review on parliamentary privilege.

Conclusion:
The court, recognizing the substantial question of law relating to the interpretation of the Constitution, referred the issue to a Constitution Bench under Article 145(3). The questions framed for reference were:
(i) Whether the court can refer to and rely upon the report of the Parliamentary Standing Committee in litigation under Article 32 or Article 136.
(ii) Whether such a report can be looked at for reference purposes, considering the concept of parliamentary privilege and the balance between constitutional institutions as conceived in Articles 105, 121, and 122 of the Constitution.

The papers were directed to be placed before the Chief Justice of India for the constitution of an appropriate Bench.

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