‘Drugs and Cosmetics Act Protects Public Health’; Proceedings in ‘Not of Standard Quality’ Drug Case to Continue
JAMMU, August 12: In a significant ruling concerning drug safety, public health and corporate responsibility, the High Court of Jammu & Kashmir and Ladakh has held that access to safe and quality medicines is an integral part of the fundamental right to life guaranteed under Article 21 of the Constitution.
The High Court has refused to quash criminal proceedings against directors of a pharmaceutical company in a case involving a drug declared “Not of Standard Quality”, holding that technical or procedural objections cannot be used to defeat a legitimate prosecution at the preliminary stage.
Justice Wasim Sadiq Nargal, while pronouncing the judgment, observed that the Drugs and Cosmetics Act is not merely a regulatory framework for the pharmaceutical industry but is also aimed at protecting public health and human life.
The Court observed that consumers have a legitimate expectation that medicines manufactured and supplied for human consumption meet the prescribed standards of quality, safety and efficacy. Any medicine falling below such standards has a direct impact on public health and safety.
Case Involves ‘Not of Standard Quality’ Drug
The observations came while deciding a criminal miscellaneous petition arising from proceedings against directors of M/s Corona Remedies Pvt. Ltd.
The case relates to Locipil Tablets, a sample of which was lifted by a Drugs Inspector of the Central Drugs Standard Control Organisation (CDSCO) from ESIC Model Hospital, Bari Brahmana, Jammu.
The sample was subsequently sent to the Regional Drugs Testing Laboratory, Chandigarh, where the Government Analyst declared it “Not of Standard Quality.”
Following the report, the pharmaceutical company was informed and submitted its response. A subsequent joint inspection of the manufacturing unit at Solan, Himachal Pradesh, was also conducted.
Directors Sought Quashing of Criminal Proceedings
The petitioners, who were directors of the pharmaceutical company, sought quashing of the proceedings, contending that they were primarily responsible for the financial and policy affairs of the company and were stationed at Ahmedabad, while the manufacturing facility was located at Solan.
They argued that they were not physically present at the manufacturing unit and had no direct involvement in the production of the drug.
The directors also relied upon the joint inspection report and raised objections regarding alleged non-compliance with statutory procedures under the Drugs and Cosmetics Act.
The High Court, however, declined to terminate the criminal proceedings merely on the basis of such objections.
No ‘Hyper-Technical’ Approach in Public Health Matters
The Court emphasised that the public-health objective of the legislation assumes special significance when the allegation relates to a medicine declared “Not of Standard Quality.”
It held that criminal proceedings should not be quashed at the threshold by adopting a hyper-technical approach, particularly when the complaint discloses the ingredients of an alleged offence and disputed factual issues require examination during trial.
The Court also made it clear that the directors would have an opportunity before the trial court to establish through evidence that they had no role or responsibility in the alleged offence.
Directors Cannot Automatically Claim Immunity
The High Court observed that merely because manufacturing activities are carried out under the supervision of qualified technical personnel, directors cannot automatically claim complete immunity from liability under Section 34 of the Drugs and Cosmetics Act.
The Court said the degree of responsibility and control exercised by the directors over the affairs of the company, along with the applicability of the statutory provisions, would have to be determined on the basis of evidence during trial.
Whether the directors were actually in charge of and responsible for the conduct of the company’s business, the Court observed, is a matter requiring proper appreciation of evidence and cannot be conclusively decided at the preliminary stage.
High Court Cautions Against Stifling Legitimate Prosecution
On the issue of its inherent jurisdiction, Justice Nargal reiterated that the power to quash criminal proceedings must be exercised with great caution.
Referring to the Supreme Court judgment in State of Karnataka vs M. Devendrappa, the Court observed that inherent powers should not be exercised in a manner that stifles a legitimate prosecution.
The High Court said it should ordinarily avoid undertaking a detailed assessment of evidence at the threshold when the facts remain incomplete or disputed questions require adjudication by the trial court.
Trial Court to Examine Evidence Independently
The Court further held that it was not required at this stage to conduct a meticulous examination to determine whether the accused would ultimately be convicted or acquitted.
It observed that where a complaint, read as a whole, discloses the ingredients of an offence and is not shown to be frivolous, vexatious or mala fide, interference at the preliminary stage would not be justified.
The Bench found that the issues raised by the directors—including their alleged non-involvement in manufacturing, their responsibility for the company’s affairs, the joint inspection report and alleged statutory deficiencies—were matters requiring examination of factual and evidentiary material by the trial court.
Petition Dismissed; Criminal Proceedings to Continue
The High Court found no patent illegality, jurisdictional error or perversity in the order passed by the Chief Judicial Magistrate, Jammu, whereby cognizance had been taken in the matter.
Consequently, the petition filed by the directors was dismissed as devoid of merit, while the interim order staying further proceedings before the Chief Judicial Magistrate was vacated.
The trial court has been directed to proceed with the case in accordance with law and independently on its own merits, without being influenced by the observations made by the High Court.
The judgment reinforces the principle that drug safety is directly linked to the constitutional right to life and public health, and that pharmaceutical companies and their responsible directors cannot seek an early escape from prosecution merely by relying on technical or procedural objections.(KNC)
