Supreme Court Refuses To Entertain PIL Seeking SOP And Stricter Measures Against Fake Medicines; Asks Petitioner To Approach Authorities

The Supreme Court has disposed of a Public Interest Litigation (PIL) seeking time-bound investigations, a national Standard Operating Procedure (SOP), and stricter measures against fake and spurious medicines, directing the petitioner to approach the respondent authorities instead.

The Court declined to express any opinion on the merits of the case, observing that the petitioner had not approached the relevant government authorities prior to filing the writ petition.

A writ petition under Article 32 was filed seeking direction to the Centre & the States to complete the investigation of fake medicine cases, time-bound assessment and confiscation of properties of fake medicine manufacturers, sellers, financiers & their family members under the PMLA, Benami Property Act and Black Money Act and frame an SOP for search, seizure and sampling of adulterated spurious medicines; and prescribe a timeline for submission of FSL reports in fake medicine cases.

The Bench comprising Chief Justice of India Surya Kant, Justice Joymalya Bagchi and Justice V Mohana ordered, "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 petitioner undertakes to deposit the requisite copies of the paper book within a week's time."

Advocate Ashwini Kumar Upadhyay appeared in person

The Plea stated that there is no standard investigation procedure, time-bound trial and sentencing policy in cases of adulterated & spurious drinks and drugs. Despite the Drug & Cosmetics Act being in force since 1940, sale and manufacturing of fake medicines, syrup, injection & vaccine continue to rise.

Upadhyay submitted, "The vacuum is this. 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. More people die due to fake drugs...Terrorists kill a maximum of 1,000 people every year, and fake drug manufacturers kill around 1 lakh people."

The Court asked, "Have you given any suggestions or made any recommendations to the authorities on how they should act upon this?...What we will do, we will send your writ petition as a representation to them, and let them consider your suggestions."

It was submitted that there is a vacuum in the existing framework, which leads to its non-enforcement.

The petitioner highlighted the rise in the manufacturing, sale, and distribution of spurious, counterfeit, and adulterated medicines, injections, and syrups across various states, allegedly resulting in large-scale casualties and severe organ damage.

Reference has been made to many such incidents, including contaminated cough syrups causing the death of 14 children in Madhya Pradesh, unearthing 12 inter-state fake medicine rackets in Delhi, and the supply of counterfeit cancer drugs across over 90 hospitals in Bengaluru. It is claimed that over 2 lakh citizens die unnaturally and 20 lakhs suffer serious illness annually due to these fake medicines.

According to the petitioner, the implementation of the Drugs and Cosmetics Act, 1940 is impeded by the absence of a uniform timeline and investigative standards. There is a complete absence of standard operating procedures for search, seizure, digital recording, and inventory preparation, as well as prolonged delays in prosecution. Similarly, there is a prolonged delay in securing test reports from the state forensic laboratory.

"Fake medicines constitute a grave threat to the fundamental rights of citizens guaranteed under Articles 14, 19 and 21 of the Constitution. The precious years, opportunities and lives can never be restored; the injury is accordingly graver than the loss of any material commodity", the plea said.

The Plea, filed by AOR Aswani Kumar Dubey, submitted, "State’s failure to curb illicit trade correspondingly infringes Article 19(1)(g) rights of law-abiding citizens, whose safety, productivity and livelihoods are undermined by parallel economy & crime, exploitation and loss of a productive workforce that inevitably accompany it."

It was further alleged that manufacturing and selling fake medicine is not an individual offence but an organized crime with cascading effects on public order, family structures, and national security. It operates as an instrument of organized crime and national security compromise, engaging the Union's obligation under Article 355 independently of Article 21.

"The absence of standardized investigation framework has resulted in inconsistent investigative practices, delayed prosecution, procedural lapses and avoidable acquittals. Time-bound investigation, forensic examination & trial, coupled with stringent punishment for offenders, would significantly improve the certainty of conviction and deter future narcotics offences. At present, investigations frequently remain pending for several years owing to delays in collection of evidence, forensic examination and filing of charge sheets. Such prolonged delays weaken prosecution, result in deterioration of evidence, increase pendency before Special Courts and substantially reduce the deterrent effect", the plea said.

The plea suggested a Standard Operating Procedure (SOP) governing investigation and prosecution of offences is indispensable to ensure uniformity, transparency and scientific investigation throughout the country. It said that the SOP may include components like: a) Preservation of Physical, Digital, Electronic Evidence; b) Early Identification of Syndicates; c) Standardized Financial Investigation & Asset Tracing; d) Uniform Coordination; e) Time-Bound Investigation and Prosecution; f) Witness Protection and Confidentiality; g) National Digital Monitoring System; and h) Accountability for Non-Compliance.

"Existing sentencing framework does not distinguish between ordinary offenders and organized syndicates, financiers, repeat offenders and those operating pan India. Absence of a comprehensive sentencing policy proportionate to the gravity, continuity, organized nature of such offences diminishes the deterrent object. This Court has consistently recognized that fake medicine is a crime against society requiring a strict approach", the Plea averred.

The plea said that the absence of a statutory or administrative timeline governing the forensic examination of seized medicines has resulted in prolonged delays in obtaining Forensic Science Laboratory (FSL) reports, thereby delaying investigation, filing of charge-sheets, commencement of trial and final adjudication. Such delays not only prejudice the prosecution by weakening scientific evidence but also infringe the constitutional right to speedy investigation and speedy trial guaranteed under Article 21 of the Constitution.

Accordingly, the plea was disposed of.

Cause Title: Ashwani Kumar Upadhyay v. Union of India & Ors. [W.P.(Crl.) No. 373/2026]