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Warning letters, 483s, Recalls, Import Alerts, Audit observations
Warning letters, 483s, Recalls, Import Alerts, Audit observations
Reports of child deaths linked to contaminated cough syrups are once again creating panic in India. As per news reports more than 14 deaths are reported in states of Madhya Pradesh, Rajasthan with investigations pointing to spurious formulations containing toxic ingredients.
The investigations has so far revealed at least one such product – Coldrif cough syrup, manufactured by Sresan Pharmaceuticals in Kanchipuram, Tamil Nadu—contain staggering 48.6% Diethylene Glycol (DEG), a toxic chemical. Tamil Nadu’s drug control authorities declared the syrup adulterated after testing Batch No. SR-13 (manufactured May 2025). Initial reports from CDSCO and Madhya Pradesh FDA had claimed the samples tested negative for DEG and EG (Ethylene glycol).
Cough syrups commonly use excipients like Glycerin and Propylene Glycol (PG), which can have contaminants DEG or EG. DEG is a highly toxic industrial chemical used in paints, lubricants, plastics, and antifreeze. Industrial grade DEG or excipients adulterated with DEG may get used as a cheap substituent for pharmaceutical grade excipients like Glycerin and Propylene Glycol in medicinal products posing grave risk to public health. As per WHO, DEG and EG are toxic to humans, and the toxic effects can include abdominal pain, vomiting, inability to pass urine, acute kidney injury leading to death.
Internationally, Pharmacopeia and guidelines have set stringent limits for DEG and EG in Pharmaceutical excipients. As per European pharmacopeia (Ph. Eur) the limit for Ethylene glycon is 620ppm and Diethyele glycol 0.10%. An USFDA guidance prescribes a limit of 0.10% each for residue content of DEG and EG and stipulate testing of samples from all containers of raw materials.
Expanding Scope: More Brands and Manufacturers Under Scrutiny
States including Madhya Pradesh, Maharashtra, Tamil Nadu, Kerala, Punjab, Himachal Pradesh, and Karnataka have issued alerts or bans on Coldrif cough syrup. Following the Coldrif ban, other brands of cough syrups have come under the scanner:
Yet, there is no national-level advisory clarifying which cough syrups are safe and which are not. India still lacks a centralized national drug database of approved medicines, leaving enforcement fragmented and reactive.
Regulatory Response: Too Little, Too Late?
The Union Health Ministry convened a high-level meeting involving the Department of Pharmaceuticals, ICMR, DGHS, DCGI, NCDC, and state drug controllers. On October 5, 2023 the DGHS issued advisories warning doctors and the public about risks from cough syrups, especially for children below 12 years. The Central Drugs Standard Control Organisation (CDSCO) is responsible for laying down the standards of drugs and coordinating state Drug Control Organisations for enforcement of the Drugs &Cosmetic Act in India. The CDSCO finally issued an advisory to State Drug controllers on 7 October 2025, alerting that:
The government action included arrest of a doctor in Madhya Pradesh (MP) for prescribing Coldrif. The Indian Medical Association (IMA) flayed the move and stated that the CDSCO and MP FDA failed to monitor DEG in cough syrups. An IMA note stated, approval of the cough syrup, monitoring quality and content of the approved drug falls within the ambit of drug regulatory system and it is concerned about the incompetence and of drug regulatory systems. The IMA cited the 2003 Mashelkar Committee Report, which had highlighted the concerns in the drug regulatory system – weak drug control infrastructure, lack of testing facilities, lack of specially trained cadres, non-availability of accurate information.
Violations of Basic GMP and Quality Standards at Sresan Pharma
Tamil Nadu FDA’s raid on Sresan Pharma revealed appalling violations:
Inspectors were shocked seeing the manufacturing practices and conditions at the facility and documented more than 39 critical and 325 major violations under the Drugs & Cosmetics Act. Ironically, the same agency was responsible for regulatory oversight and ensuring compliance at the facility. The critical GMP violations, pictures and photos of Sresan Pharma facility emerged in media paints a grim picture of the state of drug administration and control and leaves one wondering how such facilities are even allowed to operate.
Missing Warning Signs
The DEG issue in cough syrups is not new to India. WHO had issued several alerts in the past:
The DCGI (Drug Control General of India) had even issued an advisory to drug manufacturers in December, 2023 to ensure GMP and use only Pharma grade excipients in manufacture of drugs. But the recurring incidents suggest enforcement of the regulations has been weak and failure of the drug control authorities to learn from past mistakes.
Schedule M Revisions, Implementation, Enforcement
In December 2023, India revised Schedule M—the Good Manufacturing Practices (GMP) framework for pharmaceutical manufacturing:
But the case of gross contamination of Coldrif cough syrup and GMP violations at Sresan Pharma show lack of enforcement even the existing Schedule M standards. Instead of reactive measures, what is the needed is a proactive, accountable, and effective regulatory framework, implementation and enforcement of regulations and responsible manufacturing practices by the Pharma Firms.
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