How tainted cough syrups slip through India’s broken drug oversight

Cough syrup

Makeshift tin sheds, flaking walls, scattered blue poly-drums where excipients, APIs are kept, unhygienic surroundings, poor waste disposable - these were the visible outside images of Sresan Pharma’s manufacturing unit in Kanchipuram, Tamil Nadu linked to producing the tainted cough syrup that led to the death of children in Madhya Pradesh.

When Tamil Nadu’s drug inspectors arrived to inspect the facility, to their horror, they found 39 critical and 325 major violations of the Drugs and Cosmetics Act. Some of these include use of contaminated or poor-quality ingredients, lack of testing, unsanitary conditions, absence of quality control or documentation, and untrained staff.

No parent would risk their children's lives with medicines made in such a facility, but the irony is that Sresan Pharma has been selling medicines - including cough syrups - across India, and may even be exporting to other countries without accountability or oversight for years. What is equally alarming is that the central drug regulators were not aware that the company even existed, as the state drug authority had failed to report its license renewals since 2011.

It's not Sresan Pharma alone, there could be many such units operating across India, making substandard, spurious and counterfeit drugs.

Read More: India declares three cough syrups toxic after child deaths

Pharma Dichotomy

India’s pharmaceutical industry prides itself as "the Pharmacy of the World", supplying much of the world's demand for generic medicines, adhering quality expectations of some of the most stringent regulators such as USFDA, EMA, UK MHRA, Anvisa, among others. In fact, India has around 600 USFDA-compliant drug manufacturing sites, highest outside of USA. According to the Ministry of Health and Family Welfare, there are around 10,500 pharmaceutical manufacturing units with around 8,500 classified as Micro, Small, and Medium Enterprises (MSMEs).

This has also opened the debate over whether India would need those many manufacturing units, who struggle to invest on facility and quality upgradation and may not stand the scrutiny of current good manufacturing practices (cGMP). The laws governing drug manufacturing - Drugs and Cosmetics Act of 1940 – while amended over the years, may still be outdated to handle the complexities of the modern pharmaceutical industry. However, some experts say the laws are enough, what is needed is compliance and enforcement.

Cutting Corners Without Consequences

Investigations into tainted cough syrups have revealed that some manufacturers used cheaper, industrial-grade solvents like diethylene glycol instead of pharmaceutical-grade ingredients. They also skipped mandatory batch testing of raw materials and excipients, likely to save costs. While regulators often respond by suspending or cancelling manufacturing licenses and issuing show-cause notices, these actions rarely lead to criminal charges or heavy financial penalties. In some cases, companies have continued producing and exporting other drugs even after their licenses for specific products were suspended.

Fragmented and Ambiguous Oversight

India’s drug regulation is split between the central and state governments, which often leads to weak enforcement. The Central Drugs Standard Control Organisation (CDSCO) sets national standards and approves new drugs, but it’s the state drug controllers who issue manufacturing licenses and carry out inspections. This divide causes poor coordination, inconsistent enforcement, and sometimes even jurisdictional disputes.

Experts have said that there’s little communication between the central and state regulators - or even among different states. “A manufacturer whose license is cancelled in one state can potentially move to another and continue operations,” said one regulatory consultant on request for anonymity.

The quality of inspections and the willingness to take action vary widely across states. This fragmented system often leads to blame-shifting, like the current standoff between Tamil Nadu’s drug controller and the CDSCO over tainted cough syrups.

Read More: Several states ban or suspend coldrif cough syrup after child deaths in Madhya Pradesh

Vested Interests

Rajeev Raghuvanshi, who took charged as Drug Controller General in February, 20, when industry was rocked by similar scandal related to tainted cough syrup that allegedly caused child deaths in Uzbekistan and Gambia, had taken several measures earlier this year.

Raghuvanshi rejigged the team at CDSCO, shut down dozens of pharmaceutical units that were not compliant to standards and brought a digital interface to cut physical interaction between pharma companies and CDSCO. He was also instrumental in bringing revised Schedule M for Good Manufacturing Practices (GMP) to improve the quality and safety of manufacturing. The revised Schedule M was implemented on January 1, 2025. Some of these measures brought heartburn to sections within pharmaceutical industry. Finally, pharma units below Rs 250 crore annual turnover got an extension till December 31, 2025 to comply with the revised Schedule M guidelines.

Resource Crunch

Both the CDSCO and the state regulatory bodies are chronically under-staffed, and the number of drug inspectors is woefully inadequate to conduct regular and thorough inspections of all pharma manufacturing units in India. The inadequate manpower also affects the ability to conduct post-market surveillance and to draw and test a sufficient number of drug samples from the market.

While CDSCO, under Raghuvanshi did recruit more personnel, as of September 2025, even after adding 49 new recruits, the body had 181 vacant posts for drug inspectors out of 419 sanctioned positions.

Industry’s news platform Pharmabiz has reported that the Food and Drug Administration (FDA) Maharashtra - with a large manufacturing base and huge population - has 77 percent of the total sanctioned posts of drug inspectors (200) lying vacant, and the state is left to operate with a mere 46 inspectors.

It's not just manpower, but infrastructure too, as many state-run drug testing labs are poorly equipped and lack modern technology required to detect sophisticated adulterants. This can lead to delays in testing and inaccurate results, further hindering the prosecution of offenders.