Author: Shreya Rajeev Warrier, G.J. Advani Law College, Mumbai
To the Point
Between 2005 and 2011, more than 2,000 unsuspecting patients including children and mentally ill individuals were enrolled in off-label and experimental drug trials at MGM Medical College and MY Hospital in Indore, Madhya Pradesh. These trials lacked informed consent, ethical oversight, and medical justification. Despite media exposure and state enquiries, criminal prosecutions were negligible; accountability was sidelined. Public outcry and judicial intervention eventually ushered in comprehensive clinical trial reforms, enforcing protections and regulatory clarity in India’s drug testing system.
Use of Legal Jargon
The Indore Drug Trial Scam triggered the application and evolution of several critical legal concepts within the biomedical and regulatory framework in India. At the centre was the unlawful use of off-label and experimental drugs, pharmaceutical compounds tested on vulnerable patients for purposes beyond their approved therapeutic indications, in direct violation of regulatory approvals and international good clinical practices (GCP). A foundational legal breach involved the absence of informed consent, which is a legally mandated and ethically grounded requirement under Indian common law and Schedule Y of the Drugs and Cosmetics Rules. Consent must be voluntary, fully informed, and duly documented, particularly where vulnerable populations are concerned.
Moreover, these trials lacked proper Ethics Committee (EC) approval, a statutory prerequisite under the ICMR Guidelines and Drugs and Clinical Trials Rules (2019). Each clinical trial must be vetted by an Institutional Ethics Committee to safeguard participant welfare, an obligation egregiously bypassed in this case. The failure to report Adverse Events (AEs), including trial-related deaths and injuries, constituted another statutory violation under Schedule Y and DCGI guidelines, making it a case of criminal suppression and negligence.
In the aftermath, the Government of India enacted the Clinical Trials Rules, 2019, a legislative overhaul aimed at tightening compliance, ensuring compensation, and mandating audio-visual consent protocols. These reforms codified essential safeguards in response to the bioethical, constitutional, and criminal law breaches exposed by the Indore incident.
Facts of the Case
The trials were conducted primarily at Mahatma Gandhi Memorial (MGM) Medical College, MY Hospital, and the Mental Hospital in Indore, Madhya Pradesh. The period of unethical activity stretched from 2005 to 2011, with the scam coming to light in 2011. Patients subjected to the trials included the mentally ill, tribal populations, and economically backward individuals, many of whom lacked the capacity to give informed consent. The drugs used were often experimental, antibiotics and antipsychotics that were not approved in India.
It was later revealed that in over 81 clinical trials, either no consent was obtained or the forms were forged. Ethics committee approvals were either missing or falsified. There was no follow-up care, nor was compensation provided in the event of adverse effects or death. Activist Ajay Dubey exposed these violations through RTI applications, leading to media coverage and national outrage.
The Proof
Failure of Consent and Oversight
RTI reveals 1,833 patients were recruited from 2006–10 with no genuine consent; forms were fake or simplified, concealing risks and omission of hospital-level approval.
Ethics approvals were granted by distant or unverified committees, not by on-site ECs.
Deaths and Adverse Events Suppressed
Economic Offences Wing (EOW) reported 32 deaths and 49 serious events linked to 76 trials between 2006–10 .
No immediate AE reporting; patients were not compensated. As of 2011, 81 adverse events were recorded without further action
Personal Profit, Institutional Failure
Individual doctors pocketed ₹40–56 lakh each through patient recruitment
Patients were used as “guinea pigs”; their hospital admission served recruitment ends, not treatment
Weak Government Response
Temporarily banned new trials in October 2010
However, penalties were token ₹5,000 fines under MP Clinical Establishment Act (2003) and temporary MCI suspensions
No deaths referred to courts or criminally investigated.
Abstract
This article explores the Indore Drug Trial Scam as a paradigmatic exploitation of vulnerable populations in India’s unregulated clinical trial ecosystem. It unpacks how the lack of binding oversight, informed consent violations, and political inertia enabled mass trials on un-consenting subjects. Although institutional reforms followed including strengthened laws and judicial review via Suo moto hearings, justice for victims remained incomplete.
Case Laws & Judicial Developments
The judiciary, especially in suo motu interventions, played a vital role in directing executive and legislative attention to the human cost of unregulated trials.
The Supreme Court, in Swasthya Adhikar Manch v. Union of India (2013), emphasized the right to health and dignity as central to any medical research. It directed the Health Ministry to regulate trial sponsors, ensure participant safety, and create a robust compensation mechanism.
These actions led to a de facto moratorium on new clinical trial approvals until structural reforms were put in place.
Media Quoting of Court: Court asserted that treating humans as test subjects without safeguards was “unfortunate” and lacked responsibility .
MCI Suspensions (2017): MCI suspended eight doctors for three months for violations of ethical norms; doctors appealed, leading to procedural scrutiny before courts.
Regulatory Outcomes & Judicial Improvement
2010–11: State-level moratorium; ethics process reforms.
2013: Rule 122DAB introduced compensation for trial injuries or death.
2014: Mandatory audio-visual consent for all participants initiated.
2019: Drugs and Clinical Trials Rules consolidated legal requirements (EC registration, transparency, audit rights).
Judicial oversight: Courts now play proactive roles in shaping health rights jurisprudence, moving from silence to activism.
Legal Issues and Jurisdiction
The legal framework applicable at the time included the Drugs and Cosmetics Act, 1940, particularly Schedule Y of the Rules as amended in 2005; the Indian Council of Medical Research (ICMR) Guidelines for Biomedical Research on Human Participants, 2006; and most importantly, Article 21 of the Indian Constitution, which guarantees the right to life and dignity. The trials violated all these frameworks, especially the requirements for informed consent, protection of vulnerable populations, and ethical clearance.
Jurisdictionally, the High Court of Madhya Pradesh (Indore Bench) took up the matter suo motu based on media reports. At the national level, the matter was scanned by multiple regulatory and human rights bodies. Oversight and inquiries were taken up by the Drug Controller General of India (DCGI), Medical Council of India (MCI), and the Ministry of Health and Family Welfare. The National Human Rights Commission (NHRC) also intervened, and the Parliamentary Standing Committee on Health conducted a detailed review of the violations.
Legislative Reforms
The Indore scam led to significant regulatory reform in India’s clinical trial regime. In 2013, the government introduced Rule 122 DAB under the Drugs and Cosmetics Rules, making it mandatory to provide compensation for injury or death during trials. In 2014, audio-visual recording of informed consent was made compulsory to ensure transparency.
Ethics committees, which were previously unregulated, were required to register with the Central Licensing Authority. These changes culminated in the Drugs and Clinical Trials Rules, 2019, a comprehensive legislative framework that laid down timelines for reporting adverse events, ensured pre-approval requirements, and emphasized participant protection. These reforms marked a shift from investigator-driven ethics to legally enforceable patient rights.
Conclusion
The Indore Drug Trial Scam was a grave human rights abuse masquerading as medical advancement. While it spurred meaningful legal reform, it ironically failed to deliver individual justice. India’s legislative and judicial architecture improved in response, but the absence of criminal convictions and reparations remains a moral and legal deficit. For effective bioethical protection, further measures are needed: judicial interventions, whistleblower safeguards, and legal avenues for victims’ remedies. The case underscores the urgent need for a justice framework centered not only on compliance but on compassion, reparation, and ethical accountability.
FAQS
Q1. Was this case prosecuted in court?
Yes, FIRs were filed and the Madhya Pradesh High Court took suo motu cognizance. However, criminal penalties were minimal.
Q2. Were any doctors criminally prosecuted?
A: No. The doctors faced administrative penalties ₹5,000 fines and three-month MCI suspensions but no criminal charges or convictions for death or harm caused.
Q3. Were the patients compensated?
Out of over 2,000 participants, only three families received verified compensation, despite several recorded deaths and injuries.
Q4. What legal reforms followed this scam?
Major reforms that followed included the introduction of Rule 122 DAB in 2013 (for mandatory compensation), compulsory registration of Ethics Committees, the rollout of AV consent protocols in 2014, and the enactment of the comprehensive Drugs and Clinical Trials Rules in 2019.
Q5. What lessons does the scam teach future legal and medical professionals?
Accountability, ethical training, and patient-centered justice must form the foundation of clinical research law and practice.
REFERENCES
India News TOI – https://timesofindia.indiatimes.com/india/indore-docs-flout-clinical-trial-norms-earn-lakhs/articleshow/8704712.cms
Section 122 DAB in The Drugs and Cosmetics Rules, 1945 –
https://indiankanoon.org/doc/184928141/
LiveMint & Wall Street Journal – Alliance for Human Research Protection –
https://ahrp.org/indias-dark-underbelly-clinical-trial-business/
