The tragic death of 23 children in Madhya Pradesh and Rajasthan recently after consuming contaminated cough syrup has exposed the chinks in India’s drug regulatory policy, surveillance and vigilance system, and the state of public health.
People dying due to drugs containing diethylene glycol (DEG)—an industrial solvent used in antifreeze, paints, brake fluids, and plastics—is rare but not unprecedented. Such tragedies have been reported in the past in India as well as abroad.
India’s first case of DEG deaths was recorded in 1972, when 15 children died in Madras (now Chennai). In 1986, 14 people died in Mumbai; in 1988, 11 died in Bihar; and in 1998, as many as 33 children lost their lives in Gurgaon, while 150 children were hospitalised with acute kidney failure in Delhi. Between December 2019 and January 2020, at least 12 children under five years of age died in Jammu—again due to contaminated cough syrup. India-made cough syrups came under global scanner after they were linked to deaths of 70 children in Gambia, 20 in Uzbekistan, and 12 in Cameron during 2022-23.
As India’s reputation as the ‘pharmacy of the world’ suffered a severe blow, the country made it mandatory for cough syrups intended for export to be tested at government-approved laboratories. However, after the initial noise and some regulatory changes, the issue subsided. The recent deaths in Madhya Pradesh and Rajasthan jolted the authorities again and raised concerns globally, with the World Health Organization seeking to know if these medicines were shipped from India to other countries.
While the UN body expressed concern over the regulatory gap in DEG screening for the domestic market, the Central Drugs Standard Control Organisation (CDSCO), the apex regulatory body, accepted that not one, but three medicines had the toxic DEG.
No lessons learned
Experts say the fact that India still reports cough syrup deaths shows that no lessons have been learnt from past mistakes, despite previous fact-finding teams giving clear directions as to what should be done to prevent deaths.
In the latest incident, the Coldrif cough syrup, manufactured by Sresan Pharmaceuticals based in Kancheepuram district in Tamil Nadu, was found to contain DEG beyond the permissible limits. The owner of the pharmaceutical company, G Ranganathan, 75, has since been arrested and faces serious charges including culpable homicide not amounting to murder, drug adulteration, and violations of the Drugs and Cosmetics Act. The Tamil Nadu government is likely to cancel the company’s licence.
Experts see a similar cycle of reaction whenever such tragedies strike. In the latest incident, first came denial (that DEG was not detected); then arrest (doctor who prescribed the drug arrested in Madhya Pradesh), followed by suspensions (of the MP Deputy Controller and two drug inspectors from the Food and Drugs Administration), transfers (of the MP Drug Controller); and blame game.
“It is pathetic that people have such a short memory. No one was bothered when so many children were dying over the past month in Madhya Pradesh. We are still grappling with the same situation. No lessons have been learned,” said Dr Ishwar Gilada, who was in 1986 attached to J J Hospital in Mumbai, where 14 people died due to glycerol.
“It is a shame that despite India being called the pharmacy of the world, we are seeing cough syrup-linked deaths,” said Ravi Udaya Bhaskar, honorary director-general, All India Drugs Control Officers' Confederation
Weak quality control
Prashant Reddy, co-author of The Truth Pill: The Myth of Drug Regulation in India, said that children are dying because manufacturers of these cough syrups are not conducting the required testing for DEG contamination. According to the Drugs Rules 1945, manufacturers are required to conduct testing on each batch of raw materials and finished pharmaceutical products before they are released into the market.
“Ideally, the government should be conducting inquiries to determine what is going wrong. That rarely happens,” Reddy said.
Dr Sangeeta Sharma, professor and head, Neuropsychopharmacology at the Institute of Human Behaviour and Allied Sciences, explained that contamination usually occurs when poor-quality or adulterated raw materials (such as glycerine) or industrial-grade raw materials are used instead of pharmaceutical-grade raw materials and then are not adequately tested.
In some cases, manufacturers skip or falsify mandatory batch testing or do not have adequate infrastructure for testing, she said. This was also noted in the aftermath of the MP and Rajasthan incidents.
Flagging this issue, the Drug Controller General of India, Dr Rajeev Raghuvanshi, issued an advisory on October 7. Without naming any company, the advisory said some pharma units have failed to follow the rule to test every batch of medicinal ingredients.
Experts also cite unsafe supply chains, which help contaminated raw materials enter production unchecked.
Who is to be blamed?
“Responsibility is shared,” said Dr Sharma, adding that manufacturers skip and sometimes falsify quality checks, suppliers trade in impure ingredients, and regulators have weak oversight. That means thousands of small manufacturers are operating with minimal supervision, patchy inspection, and inadequate testing infrastructure.
Chinu Srinivasaan, a managing trustee of Low Cost Standard Therapeutics, a Vadodara-based charitable trust, said authorities should have conducted the tests in the best labs. “Investigations should be done to determine whether the manufacturer conducted all the required tests. The supplier and the entire supply chain should be investigated, too.”
Bhaskar, former director-general of Pharmexcil, an authorised export promotion agency under the Ministry of Commerce and Industry, said the blame falls on the CDSCO and the MP government, as it raises questions about the testing procedure. “It was the Tamil Nadu Food and Drug Administration that detected DEG above the permissible limit in the cough syrup. Before this, both the state and the CDSCO had said that no DEG was found.”
Dr Gilada said the best way would've been to test samples from every suspected cough syrup batch across multiple labs – including the CDSCO lab, state forensics lab, Indian Pharmacopoeia lab, and one independent lab. The obvious symptoms should have alerted authorities: the children, who died since the end of August, were the same as seen in Jammu in 2019-2020 and in Mumbai in 1986.
Two laws
In India, there are two laws governing pharma manufacturing units: large-scale manufacturers and micro, small, and medium enterprises (MSMEs), which have a turnover of less than Rs 250 crore. The Centre in December 2023 notified the implementation of the revised Schedule M standards, which are in line with the WHO’s Good Manufacturing Practices. However, it gave more time to MSMEs to comply with standards – initially six months but then extended the timeline till December 2025.
“This is a policy of bankruptcy,” said Bhaskar, adding that applying two different laws for two categories of manufacturers is not seen anywhere in the world. He said if MSMEs are unable to upgrade their manufacturing standards, then the government should have stepped in to help them.
In the revised Schedule M, labelled as 'Good Manufacturing Practices and Requirements of Premises, Plant and Equipment for Pharmaceutical Products,' the government added more features. They included standards for Pharmaceutical Quality System, Quality Risk Management, Product Quality Review, qualification and validation, establishment of a system for recalling defective products, a self-inspection team, quality audits, supplier audits and approvals, and stability studies.
The aftermath
After the recent deaths, the Union health ministry held an emergency meeting and asked all states/UTs to review compliance with drug quality norms. Parallelly, the CDSCO announced that it has begun risk-based inspections of 19 manufacturing facilities in six states, including Madhya Pradesh and Tamil Nadu, to identify systemic gaps and strengthen quality assurance mechanisms.
In its October 8 response to the WHO, CDSCO said it detected DEG in at least three oral syrup medicines. “These medicines were among those consumed by children in the reported cluster of cases.”
One of the contaminated products was a Coldrif batch that had 48.6% of DEG. The second was Respifresh TR, manufactured by Rednex Pharmaceuticals, Gujarat, which had 1.342% of DEG. Similarly, ReLife, manufactured by Shape Pharma, Gujarat, had 0.616% of DEG.
The CDSCO informed the WHO that all the contaminated products have been recalled and that the identified manufacturers have been ordered to stop production of all medical products.
The way forward
In a letter to Union health minister JP Nadda, Indian Medical Association president Dr Dilip Bhanushali said India should introduce a statutory requirement for manufacturers to provide mandatory toxicological clearance and test every batch of excipients (specifically Propylene Glycol, Glycerin, and Sorbitol) for DEG and EG contamination from an NABL-accredited laboratory before batch release, and this must be verified by the state drug regulator.
He also suggested increasing investment in the Pharmacovigilance Programme of India. "The system needs to be made comprehensive, digitally integrated, and accessible to capture adverse drug reactions rapidly across all parts of the country, enabling regulators to detect quality signals before they escalate into fatalities,” Nadda said.
The best way forward is well-equipped testing labs; more drug enforcement officers; and to fix accountability and prosecute violators.
“We need to conduct mandatory batch testing of all paediatric syrups and key ingredients; strict enforcement of GMP with unannounced inspections; supply-chain traceability for every raw material and batch,” Dr Sharma said.
Reddy, a lawyer specialising in intellectual property law and drug regulation, said the country needs sweeping reform of India's drug regulatory law. “The government can start by making the entire regulatory framework more transparent.”
Also, there is a need to separate food administration from drug administration to ensure the Drugs and Cosmetics Act is stringently implemented.
