New Delhi: The central government has undertaken a comprehensive and stringent audit of more than 700 cough syrup manufacturers across India in response to the recent spate of child deaths allegedly linked to contaminated cough syrups. The matter was raised in the Rajya Sabha on Tuesday, where Minister of State for Health Anupriya Patel provided detailed information about the actions taken by central and state drug regulatory authorities to safeguard public health and prevent further tragedies.

The intensified scrutiny comes in the wake of reports from Chhindwara, Madhya Pradesh, where clusters of child fatalities were suspected to be connected to the consumption of contaminated cough syrup formulations. Upon receiving these reports, a central team of experts immediately visited Chhindwara and Nagpur to conduct a thorough investigation in coordination with the Madhya Pradesh state authorities. The multi-disciplinary central team included an epidemiologist, a microbiologist, an entomologist, and several drug inspectors from the National Centre for Disease Control (NCDC), National Institute of Virology (NIV), and the Central Drugs Standard Control Organisation (CDSCO).

During the investigation, the team collected a total of 19 drug samples, reportedly consumed by the affected children, from both private healthcare practitioners and nearby retail stores for detailed chemical analysis. The results of the tests indicated that 15 samples were of standard quality, while four samples were found not to meet the standard quality requirements, raising serious safety concerns.

A key finding from the investigation revealed that one of the deceased children had consumed Syrup Coldrif, manufactured by Sresan Pharmaceutical in Kancheepuram, Tamil Nadu, which contained Diethylene Glycol (DEG) at a concentration of 46.28 per cent w/v, a highly toxic chemical not meant for human consumption. DEG is a known industrial solvent, and even small amounts can cause acute kidney failure, liver damage, and death, particularly in children.

Following the alarming results, CDSCO, in coordination with the Tamil Nadu state authorities, conducted a detailed inspection of the Sresan Pharmaceuticals facility. Investigators observed several critical and major violations of Good Manufacturing Practices (GMP), including unhygienic storage conditions and inadequate safety measures. These lapses underscored the urgent need for stricter regulatory oversight in the pharmaceutical manufacturing sector. In response to these findings, the Tamil Nadu State Drugs Controller immediately cancelled the manufacturing license of the company.

The contaminated batches were distributed across several states, including Madhya Pradesh, Tamil Nadu, Odisha, and Puducherry, prompting the respective state authorities to issue immediate bans and recalls of the affected products. The government also confirmed that a criminal case has been registered in Madhya Pradesh, and arrests have been made in connection with the deaths. Investigations are ongoing, and authorities are coordinating to ensure that all individuals responsible for negligence and violations face legal consequences.

In addition to enforcement action against manufacturers, the Ministry of Health has issued several advisories and directives to prevent such incidents in the future. On October 3, 2025, an advisory was circulated to the health departments and healthcare facilities of all states and Union territories, urging rational use of paediatric cough syrupsand caution against indiscriminate prescription. Following this, on October 7, 2025, the CDSCO directed all state and Union Territory drug controllers to ensure strict compliance with testing requirements under the Drugs Rules, 1945. Further, on October 21, 2025, the authorities instructed enhanced vigilance against spurious and substandard drugs, emphasizing prompt enforcement action under the Drugs and Cosmetics Act, 1940.

Patel informed Rajya Sabha that over 700 cough syrup manufacturers have been subjected to intense auditscoordinated with state authorities. These audits include detailed inspection of manufacturing practices, storage conditions, quality control processes, and record-keeping. Additionally, central and state regulators have increased market surveillance sampling of syrup formulations to ensure the safety of products available to the public. This multi-pronged approach is aimed at preventing the sale and distribution of substandard or contaminated cough syrups, particularly those intended for paediatric use.

Beyond regulatory oversight, the government has also introduced revisions in pharmacopoeial standards to strengthen safety protocols. The Indian Pharmacopoeia Commission, Ghaziabad, issued an amendment to the Indian Pharmacopoeia 2022, mandating testing for Diethylene Glycol (DEG) and Ethylene Glycol in oral liquids at the finished product stage before they are released into the market. This step represents a proactive approach to ensure that all syrup formulations undergo rigorous quality checks, minimizing the risk of contamination and ensuring compliance with national safety standards.

The incident has highlighted vulnerabilities in the pharmaceutical supply chain, particularly concerning small and medium-sized manufacturers of paediatric syrups. Regulatory authorities emphasize that adherence to Good Manufacturing Practices, regular internal audits, and systematic testing of raw materials and finished products are essential to prevent similar tragedies in the future. The use of toxic industrial chemicals such as DEG in consumable medicines represents a grave violation of both ethical and legal standards and demands stringent punitive measures to deter malpractice in the sector.

Health experts and government officials have stressed that public awareness and reporting mechanisms are equally crucial in safeguarding child health. Parents and healthcare providers are urged to verify product authenticity, check for approved manufacturers, and report any adverse events promptly. Coordinated action between central regulators, state authorities, and healthcare professionals is critical for early detection of contaminated batches and timely intervention to prevent fatalities.

The Ministry of Health also highlighted the importance of capacity building and training for state drug inspectors and local enforcement authorities. Ensuring that inspectors are equipped with modern testing tools, technical expertise, and robust monitoring frameworks will strengthen regulatory oversight and enable rapid response to potential violations. The CDSCO has committed to enhancing coordination with state authorities, increasing unannounced inspections, and adopting technology-driven tracking systems for medicines to ensure end-to-end accountability.

In conclusion, the government’s response to the cough syrup-related child deaths underscores the seriousness with which public health violations are being addressed. The combination of targeted audits, criminal investigations, recalls, pharmacopoeial amendments, and market surveillance represents a comprehensive approach to protecting children and restoring public confidence in paediatric medicines. While the immediate focus remains on identifying and penalizing negligent manufacturers, the long-term strategy emphasizes systemic reforms to ensure safe, high-quality, and reliable medicines are available across India.

As investigations continue, the government has pledged to maintain heightened vigilance over all pharmaceutical products, particularly those intended for vulnerable populations. The multi-agency approach, involving epidemiologists, microbiologists, drug inspectors, and state authorities, is designed to prevent recurrence of such incidents and reinforce the culture of safety and compliance within the pharmaceutical sector. With over 700 manufacturers already audited and regulatory measures being strengthened, authorities aim to safeguard children’s health and prevent future tragedies related to contaminated cough syrups.