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Section 18(c) and 27(b)(ii) of the Drugs and Cosmetics Act

Charitable Distribution of COVID Drugs During Emergency Not Subject to Licensing Under Section 18(c) D&C Act: Delhi High Court - 2025-11-21

Subject : Criminal Law - Quashing of Criminal Proceedings

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Charitable Distribution of COVID Drugs During Emergency Not Subject to Licensing Under Section 18(c) D&C Act: Delhi High Court

Supreme Today News Desk

A Helping Hand in a Public Health Crisis: Delhi HC Quashes Prosecution Against Gautam Gambhir Foundation

In a significant judgment regarding the legal boundaries of charitable work during a national emergency, the High Court of Delhi has quashed criminal proceedings against the Gautam Gambhir Foundation and its trustees. The case, which centered on the foundation’s efforts to provide life-saving medication during the deadly second wave of the COVID-19 pandemic, reinforces the principle that humanitarian intent, when supported by professional oversight, does not constitute a criminal breach of the Drugs and Cosmetics Act (D&C Act) .

The Pandemic Response and the Legal Shadow

In April and May 2021, as Delhi’s healthcare infrastructure buckled under the surge of COVID-19 infections, the Gautam Gambhir Foundation collaborated with Garg Hospital to organize a free medical camp. The purpose was to bridge the gap in access to critical medicines like Favipiravir and medical oxygen.

While the initiative was initially recognized by authorities as a voluntary effort to save lives, the Drugs Control Department shifted its stance in July 2021, filing a criminal complaint under Section 18(c) read with Section 27(b)(ii) of the D&C Act. The charge: unlicensed stocking and distribution of drugs. The foundation, facing a potential mandatory minimum sentence of three years, approached the High Court to quash the summons.

Arguments: The Clash Between Technical Compliance and Humanitarian Intent

The petitioners argued that the prohibition under Section 18(c) is aimed at commercial activities involving the sale and distribution of drugs. They contended that there was a complete absence of mens rea or profit motive. The foundation maintained that it complied with all necessary sourcing requirements, procuring medicines from licensed dealers, and that the distribution was conducted exclusively under the medical supervision of Garg Hospital practitioners—fulfilling criteria for exemption under Entry 5 of Schedule K of the Drugs and Cosmetics Rules.

The respondent, conversely, argued that the D&C Act is a "strict liability" statute. They contended that the act of distribution, regardless of motive, requires a license, and the foundation could not claim the exemption because it initiated the procurement independently, rather than the hospital.

Judicial Analysis: Safeguarding the "Samaritan"

Justice Neena Bansal Krishna, presiding over the matter, systematically dismantled the respondent's reliance on technicalities over the spirit of the law. The Court distinguished between illicit, commercial black-marketing and bona fide charitable efforts performed during a crisis.

Drawing on the precedent set by the Supreme Court of India in Mohd. Shabir v. State of Maharashtra , the Court clarified that stocking or exhibiting drugs is an offence only if it is for the purpose of sale. Furthermore, citing S. Athilakshmi v. State Rep. by the Drugs Inspector , the Court held that the provision of medical treatment under supervision—without a commercial, over-the-counter element—falls well within the legislative exemptions meant to assist the public in times of need.

Key Observations

The Court underscored that criminal law cannot be used as an instrument to penalize those who stepped in to support an overwhelmed State machinery:

  • On the nature of the offence: "The Apex Court unequivocally concluded that 'possession simpliciter of the articles, does not appear to be punishable under any of the provisions of the Act' and that the prosecution must affirmatively prove that the accused had stocked the drugs 'for sale'."
  • On legislative intent: "The Foundation’s actions were purely charitable, free of cost, and undertaken to save lives during a public health emergency, the essential ingredient of 'commercial intent' is absent..."
  • On the abuse of legal process: "To allow a prosecution to continue in such circumstances, where the act itself, is fundamentally contrary to the mischief the statute seeks to remedy, would be a gross abuse of the process of law."

Final Ruling and Implications

The High Court ultimately allowed the petition, ordering the quashing of the criminal complaint and the subsequent summoning orders issued by the Magistrate.

This decision provides substantial legal cover for non-profit organizations and private entities that provide essential services during public health crises. It establishes a critical legal precedent: that provided the procurement is transparent, the storage is safe, and the distribution is under qualified medical supervision, altruistic initiatives are not to be shackled by the hyper-technical interpretation of licensing laws. The judgment acts as a shield for "samaritans," ensuring that the fear of prosecution does not deter life-saving humanitarian action in future emergencies.

Favipiravir - Charitable distribution - Public health emergency - Licensing requirements - Good faith - Medical supervision

#CriminalLaw #DrugsAndCosmeticsAct

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