Supreme Court Refuses to Entertain Ashwini Kumar Upadhyay's PIL on Fake Medicines

The Supreme Court on Wednesday declined to entertain a Public Interest Litigation (PIL) filed by advocate Ashwini Kumar Upadhyay seeking a comprehensive legal framework to tackle the menace of fake and spurious medicines. The bench, comprising Chief Justice Surya Kant and Justices Joymalya Bagchi and V Mohana, disposed of the petition on the ground that the petitioner had not first approached the concerned government authorities with his suggestions. However, the Court directed its registry to forward a copy of the writ petition to the Union of India for consideration.

The PIL, filed under Article 32 of the Constitution, raised serious concerns over the rampant circulation of counterfeit cancer drugs, adulterated syrups, and other life-saving medicines, and sought directions for time-bound investigations, a national Standard Operating Procedure (SOP) for search and seizure, and the inclusion of fake drug manufacturing within the legal definition of organized crime.

The Petition and Reliefs Sought

Advocate Upadhyay, appearing in person, argued that the current legal framework under the Drugs and Cosmetics Act, 1940 is inadequate to curb the growing trade in fake medicines. His plea highlighted that despite stringent provisions, the manufacture and sale of spurious drugs are not treated as organized crime under the Bharatiya Nyaya Sanhita (BNS) or state-specific laws like the Maharashtra Control of Organised Crime Act (MCOCA) and the Gujarat Control of Organised Crime Act (GUJCTOC). The petitioner claimed this legal vacuum leads to inconsistent investigations, delayed prosecutions, and avoidable acquittals.

Among the specific reliefs sought were: time-bound assessment and confiscation of properties of fake drug manufacturers, sellers, financiers, and their family members under the Prevention of Money Laundering Act (PMLA), the Benami Property Act, and the Black Money Act; formulation of a uniform SOP for search, seizure, and sampling of adulterated or spurious medicines; and a fixed timeline for submission of Forensic Science Laboratory (FSL) reports in fake medicine cases.

The plea further contended that the absence of a standardized investigation framework has resulted in " inconsistent investigative practices , delayed prosecution , procedural lapses and avoidable acquittals ." It emphasized that time-bound investigation, forensic examination , and trial, coupled with stringent punishment , would "significantly improve the certainty of conviction and deter future narcotics offences." The petitioner also stressed that the existing sentencing framework does not distinguish between ordinary offenders and organized syndicates , financiers , or repeat offenders , thereby diminishing the deterrent effect .

The Arguments: A Legal Vacuum on Organized Crime

During the hearing, Upadhyay submitted that there is a critical lacuna in the law . "We have Section 111 in the BNS , but manufacturing and selling fake drugs is not considered as an organized crime . We have the state laws: Maharashtra has MCOCA, Gujarat has GUJCTOC, every state has a law to tackle organized crime . Unfortunately, manufacturing and selling fake drugs is not considered organized even under MCOCA and GUJCTOC," he argued.

To illustrate the gravity of the issue, the petitioner drew a stark comparison: "Terrorists kill a maximum of 1,000 people every year, and fake drug manufacturers kill around 1 lakh people." In response, Justice Joymalya Bagchi remarked that more people die in motor accidents, but the Court did not engage further on the statistics.

The petition cited several alarming incidents, including contaminated cough syrups causing the death of 14 children in Madhya Pradesh, the unearthing of 12 inter-state fake medicine rackets in Delhi, and the supply of counterfeit cancer drugs across over 90 hospitals in Bengaluru. It claimed that over 2 lakh citizens die unnaturally and 20 lakh suffer serious illness annually due to fake medicines.

The Court’s Observations and Order

The bench, however, noted that the petitioner had not approached the relevant authorities before filing the writ petition . "We, however, find that the petitioner has not approached the respondent authorities before filing the instant writ petition . In such circumstances where different kinds of actions are strictly required to be undertaken by the respondents, we dispose of this writ petition , without expressing anything on merits, with a direction to the registry to forward a copy of the writ petition to the respondent authorities for their consideration," the order stated.

The Court further recorded the petitioner’s undertaking to deposit the requisite copies of the paper book within a week. The bench made it clear that it was not expressing any opinion on the merits of the case, leaving it to the government to consider the suggestions advanced in the petition.

Legal Implications and Broader Impact

The disposal of this PIL, while technically a refusal to entertain, carries significant implications. The Supreme Court’s decision to forward the petition to the Union Government as a representation provides a procedural pathway for the petitioner’s suggestions to be examined at the policy level. However, it also reinforces the principle that courts generally require litigants to exhaust alternative remedies or approach executive authorities before invoking the extraordinary writ jurisdiction under Article 32.

From a substantive standpoint, the case highlights a growing concern among legal practitioners and public health advocates about the inadequacy of existing criminal law framework to deal with large-scale fake drug operations. The petitioner’s argument that such activities constitute organized crime—with cascading effects on public order, family structures, and national security—is likely to spur further debate and potentially legislative attention.

The reference to the absence of a uniform SOP for search, seizure, and sampling, as well as the delays in FSL reports, underscores systemic issues that plague drug regulation enforcement. The Drugs and Cosmetics Act, despite being in force since 1940, has often been criticized for weak implementation and procedural bottlenecks. The proposed SOP, if adopted by the government, could bring much-needed consistency and transparency to investigations across states.

Conclusion

While the Supreme Court did not grant the immediate reliefs sought, the forwarding of the petition to the Union Government keeps the issue alive at the policy level. Advocate Upadhyay’s PIL has succeeded in drawing judicial and executive attention to a public health crisis that claims thousands of lives annually. Whether the government will act on the suggestions—particularly those concerning the inclusion of fake drug manufacturing under organized crime laws and the standardization of investigation procedures—remains to be seen. For now, the ball is firmly in the Centre’s court.