PIL challenging pharmaceutical safety based solely on private laboratory reports without statutory verification is not maintainable.

The petitioner filed a Public Interest Litigation (PIL) after a specific batch of Human Albumin 20% Solution (Alburel-OS), prescribed to a patient in Jabalpur, allegedly tested reactive for HIV in private laboratory tests.

The petitioner claimed to have preserved two sealed bottles and sought a court-directed independent scientific investigation, seizure of the batch, and a stay on its distribution.

Despite making representations to various health and drug regulatory authorities, the petitioner alleged that no effective regulatory action was taken.

1. Whether a Public Interest Litigation regarding pharmaceutical safety can be maintained solely on the basis of unverified private laboratory reports.

2. Whether the petitioner’s failure to follow the statutory procedure for drug testing under the Drugs and Cosmetics Act, 1940, precludes the grant of extraordinary relief under Article 226.

Statutory framework of the Drugs and Cosmetics Act, 1940, specifically Sections 22 and 23, which designate the Drugs Inspector as the authority empowered to collect and process samples for analysis through a Government Analyst.

Principles governing the exercise of extraordinary jurisdiction under Article 226 of the Constitution of India, emphasizing that judicial directions must rest upon credible, legally admissible material rather than mere suspicion or unverified private evidence.

The court reasoned that the petitioner failed to provide any corroboration from a government-notified or recognized laboratory to establish that the medicinal product was contaminated.

It observed that the mandatory legal procedure for sample collection—which includes the involvement of a Drugs Inspector and forwarding samples to a Government Analyst—was entirely bypassed.

The court noted a lack of clinical evidence, as the prescribing physician had not reported any safety concerns or adverse effects linking the drug to infection.

Given the absence of any other documented cases of contamination for this product between 2023 and 2026, the court characterized the petition as a sponsored and frivolous litigation lacking a technical foundation.

The court dismissed the writ petition, holding that the petitioner failed to establish a prima facie case for the exercise of extraordinary jurisdiction, but clarified that if any competent government authority subsequently records adverse findings, authorities remain free to take legal action.