New Delhi: The deaths of at least 20 children after consuming spurious cough syrup have once again exposed the extent to which India’s national drug regulator has hollowed out from within. The Central Drugs Standard Control Organisation (CDSCO), charged with ensuring the safety, quality and efficacy of medicines across the country, responded to the tragedy with the familiar theatre of raids, sample seizures and licence suspensions. But parliamentary replies, budget documents and a decade-long trail of corruption analysed by this newspaper make it clear that the institution is neither equipped nor willing to do what it was created to do: prevent such incidents before they happen.
The contaminated cough syrup in the present case, Coldrif, contained diethylene glycol nearly 500 times the permissible limit. It was manufactured in Tamil Nadu, distributed across state lines and consumed in Madhya Pradesh and Rajasthan without a single regulatory red flag being raised. This was not an isolated failure. Between October 2022 and March 2023, at least 90 children died in The Gambia, Uzbekistan and Cameroon after consuming Indian-manufactured syrups contaminated with diethylene glycol or ethylene glycol. In October 2022, WHO issued a global medical product alert after identifying four syrups made by Maiden Pharmaceuticals in Haryana as the likely cause of acute kidney injury that killed at least 66 children in The Gambia. The syrups—Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup—contained toxic levels of diethylene glycol and ethylene glycol.
Two months later, in December 2022, Uzbekistan’s health ministry reported the deaths of 18 children after ingesting Doc-1 Max cough syrup manufactured by Marion Biotech in Noida. Laboratory testing again found unacceptable levels of ethylene glycol. WHO issued another alert in January 2023. In March 2023, WHO issued a third alert after contaminated Naturcold syrup made by Fraken International of India was linked to at least six child deaths in Yaoundé, Cameroon. Each incident involved a different manufacturer. Each was detected only after foreign governments investigated fatalities, even as the Indian regulators failed to detect any of these violations beforehand.
The government’s own words, tabled in Parliament, confirm that CDSCO’s regulatory model is reactive by design. In a written reply to the Lok Sabha on 20 December 2024 (Unstarred Question No. 4285), the Minister of State for Chemicals and Fertilizers stated that drug alerts are issued when cases are reported and that action is taken by the concerned state licensing authorities under the Drugs and Cosmetics Act. The same reply revealed that risk-based inspections of manufacturing units began only in December 2022, decades after the law came into force. Just over 500 premises had been inspected nationwide by late 2024, and about 400 enforcement actions were taken, all by state authorities rather than the central regulator.
This is Parliament acknowledging, in black and white, that India relies on a patchwork of state enforcement triggered by post-facto alerts rather than a coherent national surveillance system. A separate Lok Sabha reply, dated 29 November 2024 (Unstarred Question No. 719), provided another glimpse of the problem’s scale. More than 50 drugs, including batches of widely used antacids and paracetamol, had been found substandard or fake by CDSCO laboratories. Once again, the government emphasised that action was taken as and when cases were reported by state authorities. The same reply listed a flurry of regulatory measures: risk-based inspections of over 400 firms, revised Good Manufacturing Practices rules notified in December 2023 with six-to-twelve-month implementation timelines depending on company size, mandatory QR codes for active pharmaceutical ingredients and top-selling brands, marketer liability rules since 2021, strengthened penalties and special courts for spurious drug offences, tighter licensing requirements including bioequivalence and stability data, mandatory joint inspections by state and CDSCO inspectors, and excipient safety submissions. It noted that over 22,000 personnel were trained in 2023-24 and over 13,000 so far in 2024-25.
The government also pointed to a Rs 1,750 crore regulatory strengthening plan, with Rs 900 crore for CDSCO and Rs 850 crore for states, under which 17 new laboratories had been constructed and 24 upgraded. These reforms are recent and fragmented, and as the recent incident proves, have not yet changed the fundamental structure of the system. The Union Budget for 2025-26 shows why. The National Pharmacovigilance Programme, the backbone of early detection, remains stuck at Rs 8.53 crore, unchanged for three years despite repeated drug safety crises. The budget head for Regulatory and Statutory Bodies, which lumps CDSCO together with other regulators, stands at Rs 584.65 crore, down from Rs 675.21 crore in the previous budget estimates. This figure covers multiple agencies, meaning CDSCO’s operational budget is a fraction of that sum. Transfers to states for regulatory strengthening remain flat at Rs 50 crore, even though the government touts a multi-year Rs 1,750 crore scheme.
CDSCO’s own 2023-24 budget reveals the scale of the problem more starkly. Its total budget was Rs 17.95 crore, comprising Rs 15.4 crore in revenue and Rs 2.54 crore in capital expenditure. Most of this went to salaries and office expenses. Training received barely Rs 17 lakh. Spending on digital equipment was cut from Rs 27 lakh in the original estimate to Rs 2.1 lakh in the revised estimate, with less than Rs 2 lakh actually spent. Advertising and public outreach, which includes adverse drug reaction bulletins, received Rs 50,000, of which Rs 15,000 was spent. The last publicly available ADR notification on the agency’s site was issued in February 2023. There has been silence since.
Zonal offices—the field units responsible for sampling, inspection and surveillance—run on allocations between Rs 27 lakh and Rs 1.48 crore, while the headquarters in Delhi absorbs nearly half the budget. An eight-crore pharmacovigilance programme and zonal offices running on shoestring allocations are expected to police a Rs 3.4 lakh crore domestic pharmaceutical industry with $27 billion in annual exports. This chronic underfunding is layered over endemic staffing shortages. As of December 2023, 303 of 504 sanctioned Drug Inspector posts—roughly 60%—were vacant. Recruitment drives for new inspectors have been slow, and field offices often function with skeletal teams even as their mandates have expanded.
Overlaying this fragility is a long and well-documented history of corruption inside the regulator. A 2012 Parliamentary Standing Committee found “sufficient evidence to conclude that there is collusive nexus between drug manufacturers, some CDSCO officials and medical experts,” after discovering that 33 of 42 drug approvals examined were granted without mandatory clinical trials, often based on evaluation reports drafted by the companies themselves. In 2019, the CBI arrested a CDSCO Drug Inspector in Baddi in a Rs 1 lakh bribery case and, days later, trapped Deputy Drug Controller Naresh Sharma at headquarters in a separate corruption case. In May 2021, two medical device officers in Ahmedabad were arrested for demanding Rs 3.5 lakh from a manufacturer. In June 2022, Joint Drugs Controller S. Eswara Reddy was arrested in Delhi while allegedly accepting Rs 4 lakh to waive Phase III clinical trials for an insulin product. These incidents, spread across more than a decade and multiple levels of the organisation, reveal a regulator structurally vulnerable to influence and capture.
The aftermath of the recent cough syrup deaths followed a familiar script. CDSCO and the Health Ministry announced inspections in six states and suspended suspect batches. On Thursday, CDSCO asked all state governments to submit a list of cough syrup manufacturers while initiating a joint audit of these companies. But these steps came only after the fatalities. The contaminated syrups moved through the system unchecked, exactly as Parliament’s replies and budget data would predict. This is a regulator designed to react, not prevent, operating with inadequate resources, limited reach, fragile surveillance, and a record of compromised oversight.
India presents itself as a global pharmaceutical leader, supplying affordable medicines to hundreds of countries. But the national drug regulator responsible for safeguarding the quality of those medicines remains underfunded, understaffed, fragmented across states, and riddled with vulnerabilities. CDSCO had assured this newspaper that it would reply to the questions raised by this report, but it did not until the time the newspaper went to print.
