Safe medicines basic right not just consumer choice, says Jammu and Kashmir High Court

“The right to life is not confined to mere physical existence, but encompasses the right to live with dignity and includes within its ambit the protection of health and well-being. Every person, as a consumer of medicines, is entitled to expect that drugs made available for human consumption conform to the prescribed standards of quality and are not sub-standard or otherwise unsafe,” the August 11 order stated.

“The manufacture and distribution of drugs which fail to meet the prescribed standards, therefore, carries a direct bearing upon public health and, consequently, implicates the constitutional concern underlying Article 21,” it said.

The case arose from a batch of Locipil tablets, manufactured by Corona Remedies in September 2015 and carrying an expiry date of May 2018. A sample was lifted from ESIC Model Hospital, Bari Brahmana, Jammu, and sent for testing. In a report dated August 31, 2016, the government analyst at the Regional Drugs Testing Laboratory, Chandigarh, declared the drug “Not of Standard Quality”.

Justice Wasim Sadiq Nargal made it clear that the court was not deciding the directors’ guilt or innocence at this stage.

No role: Directors

The directors argued that they could not be held criminally liable simply because of their position. They said they were not personally involved in manufacturing the drug and that the manufacturing process was carried out by technical personnel.

They also relied on a joint inspection conducted at the manufacturing unit on November 4, 2016. The inspection recorded that the batch had been manufactured under ‘Good Manufacturing Practices’ and that the required quantity of bulk drug had been used. However, the report also recommended action under the applicable guidelines in light of the government analyst’s findings.

The high court held that whether the directors were actually in charge of and responsible for the conduct of the company’s business was a question requiring evidence. Such questions could not ordinarily be decided at the threshold while exercising its inherent jurisdiction to quash proceedings.

Section 34 of the Drugs and Cosmetics Act provides for liability of persons who, when an offence is committed by a company, are in charge of and responsible for the conduct of its business. It also covers directors and other officers where the offence is committed with their consent or connivance or is attributable to their neglect. The court said whether these conditions were ultimately established was a matter for appreciation of evidence.

The court relied on the Supreme Court’s judgment in Dinesh B Patel and Others v State of Gujarat and another, which declined to adopt a technical approach in a prosecution under the Drugs and Cosmetics Act, given the public-health implications. It also referred to the Supreme Court’s 2026 judgment in State of Kerala and another v M/s Panacea Biotec Ltd and another, which held that whether directors were “in charge of” and responsible for a company’s business were questions of fact best left to the trial court.

Company seeks leniency

The court also considered the company’s response to a legal notice issued on September 22, 2016. In its November 3, 2016 reply, the company said it had stopped sale of the batch and had no stock remaining. The company further stated: “We admire your findings and honour your judgment” and requested to “take a lenient view in this concern.”

Justice Nargal said the response was significant because the company had not disputed the department’s findings at that stage. The court held that the petitioners were legally barred from challenging the complaint and process later, applying the principle of “estoppel by conduct”.

Trial court to decide

The high court held that the alleged procedural deficiencies under sections 23 and 25 of the Act did not justify quashing the proceedings at this stage. It noted that the government analyst’s report had been communicated to the company and that the company had submitted a reply. Whether the legal requirements were fully complied with and whether any prejudice was caused could be examined by the trial court.

“The statutory safeguards contained in the Drugs and Cosmetics Act must accordingly be understood as serving not merely a regulatory purpose, but also as an important legislative mechanism for protecting the health and life of persons who may be required to consume such drugs,” the court said.

Finding no patent illegality, jurisdictional error, perversity or abuse of process in the magistrate’s July 26, 2018 order, the court dismissed the petition and vacated its May 3, 2019 interim order staying proceedings before the trial court.

The high court made it clear that it was not deciding the directors’ guilt or innocence. It directed the trial court to proceed independently and decide the case on its merits, leaving open all questions requiring appreciation of evidence.