Supreme Court: Rejects Fake Medicine PIL, Directs Authorities

• The Supreme Court dismissed a Public Interest Litigation (PIL) seeking time-bound investigation and trial in cases involving fake and adulterated medicines.
• The Court's decision was based on the petitioner's failure to first approach relevant authorities, not on the merits of the case.
• Despite the dismissal, the Supreme Court directed that the petition be forwarded to central and state authorities for their formal consideration.
• Filed by Advocate Ashwini Kumar Upadhyay, the PIL highlighted significant gaps in the Drugs and Cosmetics Act, 1940, and called for reforms like time-bound forensic examinations and PMLA enforcement against illicit gains.
• The petition underscored severe public health risks, asserting that deaths from fake medicines surpass those from terrorism, naxalism, and riots.

Crucially, while the Supreme Court rejected the immediate judicial intervention, it did not entirely dismiss the concerns.

The Supreme Court recently declined to intervene directly in a Public Interest Litigation (PIL) that sought judicial directives for the Centre and various states regarding the investigation and trial of cases involving counterfeit and adulterated medicines. The petition, filed by Advocate Ashwini Kumar Upadhyay, specifically requested a time-bound framework for addressing issues related to spurious medicines, injections, vaccines, and syrups. The bench, comprising CJI Kant, Justice Bagchi, and Justice Mohana, heard the matter on September 28, 2026, and ultimately decided against issuing the requested mandates.

The Court's refusal was procedural, not a judgment on the substantive issues raised. It noted that the petitioner had not first engaged with the relevant respondent authorities before bringing the writ petition to the Supreme Court. Given that the petition called for diverse actions from these authorities, the Court opted to dispose of the matter without expressing any opinion on its merits.

Crucially, while the Supreme Court rejected the immediate judicial intervention, it did not entirely dismiss the concerns. Instead, the Court directed its registry to forward a copy of the entire writ petition to the respondent authorities for their thorough consideration. This ensures that the issues highlighted by the PIL, despite the procedural dismissal, will formally come before the executive bodies responsible for addressing them. The petitioner also undertook to submit the necessary copies of the paper book within one week.

The PIL, titled Ashwini Kumar Upadhyay v. Union of India & Ors., detailed a series of alleged deficiencies within the existing legal and enforcement framework designed to combat fake medicines in India. A primary concern was the absence of a standard operating procedure for time-bound investigations into such cases, alongside a lack of mandated timelines for forensic examination of seized medicinal products. The petitioner also pointed to the non-existence of specialized courts dedicated to ensuring time-bound trials for offenses related to spurious drugs.

Furthermore, the petition argued that the current provisions under the Drugs and Cosmetics Act, 1940, do not prescribe sufficiently stringent punishments to deter the manufacture and sale of fake medicines. It also highlighted a significant gap in the enforcement mechanism concerning financial crimes, noting that there is no systematic assessment or confiscation of properties acquired through the proceeds of crime under statutes like the Prevention of Money Laundering Act (PMLA), the Benami Property Act, or the Black Money Act. These identified lacunae, according to the petitioner, contribute directly to the non-enforcement of the existing legal framework, allowing the proliferation of fake medicines, syrups, and injections despite the 1940 Act being in force.

To rectify these issues, the PIL sought specific directives, including the completion of investigations within three months and trials within one year for fake medicine cases. It also called for the formulation of clear SOPs for the search, seizure, and sampling of adulterated drugs, along with prescribed timelines for the submission of forensic science laboratory reports. Other proposed reforms included mandatory digital recording and videography of all search, seizure, sampling, and inventory proceedings, as well as the framing of a sentencing policy to ensure severe penalties for manufacturers and sellers of counterfeit drugs. The petition further requested a direction to the Law Commission to prepare a comprehensive report and a declaration that sentences in fake medicine cases should run consecutively.

The urgency of the PIL's demands was underscored by the severe public health crisis it described. The petitioner contended that fake medicines are responsible for a wide array of serious health complications, including Hepatitis B, liver damage, cardiovascular diseases, and respiratory and neurological impairments. The petition emphasized that the harm inflicted upon the public is extensive, impacting not only physical and mental well-being but also the broader social fabric and public order.

In a stark comparison, the PIL asserted that the number of deaths attributable to fake medicines, vaccines, injections, and syrups surpasses the fatalities caused by terrorism, naxalism, and riots. This grave assessment highlighted the petitioner's view that the issue is not an isolated problem but a systemic crisis demanding immediate and comprehensive intervention. The petition argued that the magnitude of this public health threat necessitates the Supreme Court's involvement to compel effective action from the government.

While the Supreme Court rejected the PIL seeking immediate judicial intervention for time-bound investigation and trial in fake medicine cases, its direction to forward the petition to relevant authorities means the identified regulatory gaps are now formally under consideration by the Centre and States. Lawyers advising pharmaceutical companies or those in drug manufacturing/distribution should monitor for potential administrative or legislative reforms addressing these highlighted lacunae, as the issues are not dismissed but rather referred for executive review.

Source: Reporting on Indian Supreme Court proceedings.