Introduction
India, often celebrated as the "pharmacy of the world," is once again under global scrutiny following the deaths of at least 23 children across Madhya Pradesh and Rajasthan due to consumption of contaminated cough syrup. The tragedy centers around Coldrif, a pediatric cough syrup manufactured by Sresan Pharmaceuticals Limited[i] (“Sresan”), based in Tamil Nadu. Laboratory analysis of the cough syrup samples revealed the presence of 48.6% diethylene glycol (“DEG”) — an industrial solvent used in brake fluids, antifreeze, and paints, far exceeding the permissible limit of 0.1% in oral liquid formulations.
DEG is a toxic industrial solvent, if it is substituted—whether deliberately or negligently—for pharmaceutical-grade propylene glycol (a safer solvent commonly used to dissolve active ingredients in cough syrups), it can cause acute kidney failure, and in severe cases, lead to death. This risk is especially high in young children, whose renal systems are less able to process such toxins. Reports suggest that 50 kilograms of industrial grade propylene glycol was sourced by Sresan from local chemical traders and paint dealers rather than certified pharmaceutical suppliers, that too without any invoices.
The Central Drugs Standard Control Organization (“CDSCO”) confirmed that three cough syrups — Coldrif (Sresan), Respifresh-TR (Rednex Pharmaceuticals Private Limited), and ReLife (Shape Pharma Private Limited) contained DEG, intensifying the alarm.
Immediate Regulatory Action by CDSCO and State Drug Licensing Authority
Upon confirmation of DEG contamination in the Coldrif batch manufactured in May 2025, the Madhya Pradesh government swiftly banned the sale, distribution, and stock of all Coldrif syrups and extended the ban to all products manufactured by Sresan, instructing Madhya Pradesh Food and Drugs Administration drug inspectors to enforce the ban and collect additional samples for testing.
Govindhan Ranganathan, the owner of Sresan, was arrested by Tamil Nadu police on charges of culpable homicide not amounting to murder,[ii] drug adulteration,[iii] endangering personal safety[iv] under Bhartiya Nyaya Samhita, 2023 and violations of manufacturing adulterated drugs under the Drugs and Cosmetics Act, 1940[v] (“D&C Act”). Furthermore, Tamil Nadu’s Drug Control Department (“TN DCD”) has revoked the manufacturing license of Sresan.[vi]
An inspection report post incident by the TN DCD found that Sresan had violated 364 manufacturing rules, including 39 marked “very serious” and 325 “major.” The report highlighted the use of unqualified staff, contaminated water, lack of pest control, missing production monitoring, and absence of any quality assurance protocols. Products were reportedly stored in unhygienic conditions, with raw sewage discharge near production lines — a stark failure of statutory compliance. The unit also lacked key testing equipment such as gas chromatography, essential to detect impurities in raw materials.
A Pattern of Preventable Tragedies
India has witnessed multiple tragedies from DEG-contaminated cough syrups. Recent incidents include 12 deaths in Cameroon (Reimann Labs, 2023), 70 in Gambia (Maiden Pharmaceuticals, 2022), 18 in Uzbekistan (Marion Biotech, 2022), and 14 in Jammu & Kashmir (Digital Vision Pharma, 2020). Earlier outbreaks were reported in Chennai (1972), Mumbai (1986), Bihar (1988), and Delhi–Gurgaon (1998). Despite numerous expert panels, fact-finding committees, and international rebukes, systemic reform has remained slow and fragmented. Following the global outcry in 2022, India made DEG testing mandatory for exports,[vii] but for the domestic market there were glaring regulatory loopholes that persisted until this latest tragedy forced new action. Now the Indian Pharmacopoeia Commission has mandated the testing of all oral liquid formulations for DEG and Ethylene Glycol (“EG”) impurities.[viii]
Why Tragedies Keep Happening: Regulatory Gaps & Structural Weaknesses
Despite recurring incidents of cough syrup poisonings, systemic regulatory weaknesses in India continue to allow such tragedies to reoccur. Under the current framework, the CDSCO is responsible for central functions such as new drug approvals and policy formulation, while state drug controllers / state Food and Drugs Administration (“FDA”) are tasked with licensing, inspections, and enforcement at the ground level. This dual oversight model often leads to fragmentation, with inconsistent regulatory capacity across states, poor coordination, and significant gaps in communication and enforcement, creating a regulatory environment where dangerous lapses can go unnoticed until it’s too late.
For example, in the case of Sresan, reports indicate that the CDSCO was unaware of the company’s existence, as it was not listed in their database. This oversight occurred because the Tamil Nadu Food & Drugs Administration (“TN FDA”) had failed to report the company’s manufacturing license renewals since 2011. Furthermore, the company failed to comply with Rule 84AB of the Drugs & Cosmetics Rules, 1945 (“Drug Rules”), which requires licensed manufacturers to upload detailed information about their approved drugs and manufacturing facilities on the ‘Sugam’ portal- information that must be verified by the respective state FDA. Sresan is just one example, but it points to a larger systemic issue: there could be many such under-regulated manufacturing units operating across India, producing substandard, adulterated or spurious drugs with minimal oversight.
Furthermore, some states lack sufficiently equipped laboratories or qualified analysts to detect toxic contaminants like DEG and EG. Overworked drug inspectors, limited field resources, and budget constraints further erode active surveillance.
While Rule 78(c)(ii) of the Drugs Rules, clearly mandates that licensed drug manufacturers must test every batch of raw materials and final products—either in their own laboratories or those approved by the licensing authority and maintain detailed records of said tests, enforcement of these requirements remains inconsistent.
In the case of Sresan, for instance, the TN DCD confirmed that disciplinary action had been taken against the company in both 2021 and 2022 for compliance lapses. Yet, despite these prior violations, no inspection was conducted in the following years, allowing the company to continue operations unchecked. It was only after the recent tragedy that two drug inspectors were suspended for negligence, highlighting how manufacturers can persist with violations in the absence of sustained regulatory oversight.
This is not an isolated incident, according to the Comptroller and Auditor General Report, 2024 for Tamil Nadu, the state drug inspectors were supposed to carry out 1,00,800 inspections in 2020-2021, but only carried out 62,358 inspections, resulting in a 38% shortfall in inspections, in the same period, drug inspectors also fell short of targets for collecting drug samples for testing.
Why The Schedule M Amendment Alone is Not Enough
The Ministry of Health and Family Welfare (“MoHFW”) revised Schedule M of the Drugs Rules in December 2023 (“2023 Amendment”), updating India’s Good Manufacturing Practices (“GMP”) to align more closely with World Health Organization (“WHO”)-GMP and international standards. This amendment mandated stronger quality controls across manufacturing processes to enhance drug safety and prevent adulteration. However, this tragedy reveals that regulatory reforms alone are not enough, a key factor here is the delayed implementation of Schedule M requirements for Micro, Small and Medium Enterprises (“MSMEs”),[ix] allowing many smaller manufacturers to operate under older, less stringent standards for longer.
Why MSMEs Have Been Slow in Implementation—And Why Many may Not Comply
India has around 10,500 pharmaceutical manufacturing units, nearly 8,500 belong to the MSMEs sector of which less than a quarter currently hold WHO-GMP certification. Compliance with the 2023 Amendment had placed the MSME segment under significant strain as adherence is expensive, complex, and technically demanding. To support this transition, the government extended the deadline for MSMEs to comply with the revised Schedule M until 31st December 2025, this was based on the condition that the MSME must submit an application along with a detailed upgradation plan to CDSCO by 11th May 2025. However, recent data suggests that many MSMEs missed the deadline and therefore do not qualify for the compliance extension.
As of May 2025, only about 1,700 MSME drug manufacturers had submitted upgradation plans under the new norms, meaning that the majority remain non-compliant or are delaying necessary upgrades — a concerning trend given the looming regulatory deadline. Non-compliance with Schedule M[x] can lead to suspension or cancellation of manufacturing license.[xi] Financial barriers top the list of challenges; mandatory compliance, upgrading machinery, infrastructure and documentation systems requires significant investment. With thin profit margins and limited access to institutional finance, many MSMEs struggle to invest in capital-intensive projects without exposing themselves to significant financial risk.
Technical and skill gaps further compound the issue, the implementation of the revised Schedule M demands highly specialized personnels, however most MSMEs lack the trained staff and technical resources required. Operational disruption is another major deterrent: facility upgrades often require production halts or shift reconfigurations, for a small manufacturer, even short downtime can cause significant revenue losses, making them reluctant to begin upgrades that might push them further behind.
Jan Vishwas Amendment: Diluting Deterrence in Drug Regulation?
While MSMEs struggle to comply with tighter regulations, India’s legal framework simultaneously moved toward selectively decriminalizing certain drug-related offences. In 2023, Parliament passed the Jan Vishwas (Amendment of Provisions) Act, which made Section 27(d) of the D&C Act, pertaining to Not of Standard Quality[xii] (“NSQ”) drugs — a compoundable offence.[xiii] This means that manufacturers can now settle certain non‑severe violations by paying fines instead of facing criminal prosecution.
Under the Drugs & Cosmetics (Compounding of Offences) Rules, 2025,[xiv] only relatively minor offences (such as labelling errors, minor documentation lapses, or certain NSQ drug cases that do not cause harm) are eligible for compounding; serious safety violations involving toxic, adulterated, or spurious drugs; those causing bodily injury or death; or those involving manufacturing without license or in unsanitary conditions, remain subject to stringent criminal provisions. However, in practice, this selective decriminalization risks normalizing non-compliance, effectively turning penalties into a routine “cost of doing business”. This is particularly concerning in the context of MSMEs, whose quality control systems are often weaker and more vulnerable to lapses.
Where We Stand
The recent surge in regulatory vigilance and media attention is a welcome development, but it must not become another short-lived response. What is urgently needed are sustained, systemic reforms that address the root causes of regulatory failure.
The revised Schedule M is a critical step toward aligning India’s drug manufacturing standards with global norms. However, the government must recognize the genuine challenges faced by MSMEs in implementing these reforms. Without targeted financial and technical assistance, many small and medium-sized manufacturers will continue to struggle with compliance, leaving systemic vulnerabilities unaddressed.
At the same time, state drug regulators must move toward a stricter, deterrence-based model of enforcement. Random batch failures, particularly those involving NSQ (harmful), adulterated, or spurious drugs, must trigger serious consequences, especially for repeat violators. Regulatory tolerance of persistent non-compliance fosters the very conditions that lead to public health tragedies and erodes trust in the system.
Beyond stricter enforcement, there is a pressing need to build capacity in the regulatory infrastructure, thereby strengthening frontline vigilance. Many states face chronic shortages of qualified drug inspectors, and most State Drug Testing Laboratories operate with inadequate staffing, leading to testing delays and infrequent inspections. Tamil Nadu’s case highlights how such systemic weaknesses undermines regulatory oversight and compromises drug safety.
Finally, it is critical to bridge the longstanding communication gap between the CDSCO and state FDAs. Establishing a centralized regulatory database, enabling real-time data sharing, and coordinating joint inspections would help build a unified, transparent, and accountable oversight system—essential to preventing recurring quality lapses and regulatory blind spots.
Path to Victim-Centric Reform
This tragedy also exposes an uncomfortable truth: even in 2025, India still lacks a statutory mechanism to compensate victims of unsafe medicines, especially where regulatory failure is evident. While prosecutions and regulatory action are important, they do not meet the immediate needs of affected families.
The Central Government must urgently implement a robust, rights-based compensation framework. Although Section 27 of the D&C Act and draft Section 56(a) of the Draft New Drugs, Medical Devices and Cosmetics Bill, 2022 provide a legal basis, there is still no clear operational, dedicated statutory mechanism for compensating grievous harm or death caused by unsafe drugs.
To close this gap, the Central Government should establish a no-fault pharmaceutical injury compensation system that offers time-bound and equitable relief—without requiring proof of negligence. Key components should include:
- Mandatory product liability insurance for all pharmaceutical manufacturers, ensuring financial accountability for harm caused by their products.
- A dedicated No-Fault Pharmaceutical Injury Compensation Fund, administered independently under CDSCO and financed through a nominal cess on drug manufacturing licenses and sales.
Such a fund would guarantee direct support for victims and families, while avoiding lengthy litigation. By shifting the focus from fault-finding to victim assistance, the model ensures fairer outcomes and holds the system accountable, without crippling the pharmaceutical industry. Reforming India’s drug safety framework to ensure redress is not just sound policy; it is both a moral imperative and a constitutional duty.
[i] CIN: U24231TN1990PLC019816; Company Status as per MCA: Strike Off
[ii] Section 105- Punishment for culpable homicide not amounting to murder, Bhartiya Nyaya Samhita, 2023
[iii] Section 276- Adulteration of Drugs, Bhartiya Nyaya Samhita, 2023
[iv] Section 125- Act endangering life or personal safety of others, Bhartiya Nyaya Samhita, 2023
[v] Section 17A. Adulterated drugs, Drugs and Cosmetics Act, 1940
Section 18, Prohibition of manufacture and sale of certain drugs and cosmetics, Drugs and Cosmetics Act, 1940
Section 27- Penalty for manufacture, sale, etc., of drugs in contravention of this Chapter, Drugs and Cosmetics Act, 1940
[vi] Rule 85, Cancellation and suspension of licenses, Drugs and Cosmetics Rules, 1945.
[vii] Amendment in Export Policy of cough syrup (2023), https://content.dgft.gov.in/Website/dgftprod/ccc84ba9-65d3-475b-b636-16d449beb99f/Notification%20%20No%2006%20-%20English.pdf
[viii] F. No. T11015/01/2020-AR& D, Amendment List-09 to IP 2022- The said list was not uploaded on the website of the Indian pharmacopoeia at the time of publication of this article
[ix] Under the Drugs (Amendment) Rules, 2023
Small and medium manufacturers are defined as manufactures having turnover less than or equal to INR 250 crores
[x] Rule 71, Conditions for the grant of a licence in Form 25 or Form 25F, Drugs and Cosmetics Rules, 1945
[xi] Rule 85, Cancellation and suspension of licences, Drugs and Cosmetics Rules, 1945
[xii] Section 16, Standards of quality, Drugs and Cosmetics Act, 1940
[xiii] Second Schedule, Serial No. 6, Jan Vishwas (Amendment of Provisions) Act, 2023, https://egazette.gov.in/WriteReadData/2023/248047.pdf
[xiv] Section 7- Withdrawal of Immunity from Prosecution in certain conditions, Drugs and Cosmetics (Compounding of Offences) Rules, 2025
Authors:
Taskeen Pirani, Associate Partner
Sohail Vij, Associate
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