Centre launches pan-India crackdown on cough syrups; pharma owner arrested in TN

New Delhi: In the wake of the deaths of more than 20 children in Madhya Pradesh allegedly linked to contaminated cough syrups, Indian authorities have launched a sweeping national investigation targeting pharmaceutical companies involved in the manufacture of these medicines. The central drug regulator, the Central Drugs Standard Control Organisation (CDSCO), has initiated a pan-India drive to test, inspect, and audit cough syrup manufacturers, while also recalling multiple brands and instructing states to provide detailed lists of companies for monitoring. Meanwhile, the police have arrested G Ranganathan, owner of Tamil Nadu-based Sresan Pharma, which manufactured the contaminated cough syrup Coldrif.

The CDSCO has informed the World Health Organisation (WHO) that three cough syrup brands—Coldrif (manufactured by Sresan Pharma, Tamil Nadu), Respifresh TR (Shape Pharma, Gujarat), and ReLife (Rednex Pharmaceuticals, Gujarat)—have been recalled and that manufacturers have been ordered to halt their production immediately. Official sources confirmed that none of these products were exported from India. The WHO, which had requested information regarding potential international distribution, has been closely monitoring reports of paediatric illnesses and deaths in Madhya Pradesh and Rajasthan.

The children affected displayed symptoms consistent with acute renal failure and acute encephalitis syndrome, raising concerns that the illnesses were linked to consumption of the adulterated oral syrup medicines. WHO sources noted that the agency has yet to receive definitive information on the source of diethylene glycol (DEG) contamination, the toxic chemical suspected to have caused the deaths. The global health agency expressed concern over the potential risk of contaminated products being exported via unregulated channels and highlighted the existing regulatory gaps in DEG and ethylene glycol screening for medicines marketed domestically.

In Madhya Pradesh, the toll has risen to 22 children. Two more children, five-year-old Vishal and four-year-old Mayank Suryavanshi, succumbed while undergoing treatment in Nagpur, Maharashtra, according to Additional Collector Dhirendra Singh Netri. Several other children from the state are currently hospitalised in Nagpur. A Special Investigation Team (SIT) has been constituted by the Madhya Pradesh Police to probe the incident, with the state government emphasising accountability. Chief Minister Mohan Yadav accused the Tamil Nadu government of non-cooperation, stating, “We will not spare anyone playing with the lives of children,” and demanded concrete action.

The owner of Tamil Nadu-based Sresan Pharma, which manufactured Coldrif, G Ranganathan, was arrested on Thursday. The arrest came after a coordinated operation between Madhya Pradesh and Chennai police. Authorities also seized documents from the company’s Kancheepuram factory. Ranganathan was produced in a Chennai court for transit remand before being taken to Chhindwara. On October 7, the Sriperumbudur Drug Control Inspector issued a show-cause notice to the company over discrepancies in quality and labelling. Officials from the Tamil Nadu Directorate of Drugs Control reported that medicines were stored in “unhygienic conditions” in corridors, presenting a risk of contamination.

Tamil Nadu Health Minister Ma Subramanian stated that two senior drug inspectors were served notices and later suspended for failing to inspect the Sresan Pharma facility over the past two years. “Tamil Nadu was the first to confirm the adulteration in the cough syrup (Coldrif) and we immediately informed the Union Health Ministry, Madhya Pradesh, Odisha, and Puducherry about the health hazard of consuming the syrup,” he said. He further added that the state had halted procurement and banned the sale of Coldrif, averting a larger catastrophe. Subramanian confirmed that the state is considering permanent closure of the pharmaceutical company, with a decision expected within three days.

The CDSCO’s nationwide audit and inspection drive comes amid growing concern that many manufacturers are not adhering to safety and quality standards. According to an advisory issued by the Drugs Controller General of India (DCGI) on October 7, recent inspections revealed that several manufacturers are not testing each batch of excipients and active ingredients before production. The advisory stressed that all batches of raw materials and finished products must undergo rigorous testing to ensure compliance with prescribed standards. It also called on state and Union Territory drug controllers to implement corrective and preventive measures, including monitoring during inspections, sensitising manufacturers through circulars, and ensuring that only raw materials from approved vendors are used.

So far, only 18 state drug control authorities have onboarded the Online National Drugs Licensing System (ONDLS), a single-window digital platform developed by the Centre for Development of Advanced Computing (C-DAC) in collaboration with the CDSCO. ONDLS is intended to streamline drug licensing and regulatory compliance in India, but full adoption across all states and Union territories has yet to be achieved. Officials noted that no state has fully complied with the Corrective and Preventive Action (CAPA) guidelines, which were introduced to uphold safety and maintain pharmaceutical standards.

In addition to Coldrif, the Madhya Pradesh government issued alerts against Respifresh TR and ReLife, syrups manufactured by Gujarat-based Shape Pharma and Rednex Pharmaceuticals, after laboratory tests confirmed that these products contained diethylene glycol. The alert targeted batches expiring in December 2026. TN’s deputy director of drugs control, S Gurubharathi, directed a complete halt to the sale, purchase, and consumption of these syrups, citing severe health risks. Retailers, distributors, hospitals, and pharmacies were instructed to remove affected batches from their stocks immediately and report any instances of sale or supply.

Healthcare providers were advised to monitor patients for signs of DEG poisoning and to facilitate the proper disposal of contaminated products. Authorities are also actively working to seize approximately 100 bottles of Coldrif syrup from shops in Thanjavur, Tiruvannamalai, and Chengalpet. Gurubharathi confirmed that criminal proceedings have been initiated against Sresan Pharmaceuticals, noting that if convicted, the company owner could face a minimum of 10 years to life imprisonment and a fine of at least Rs 10 lakh.

The Union government, responding to the ongoing crisis, has reiterated safety measures for pharmaceutical manufacturers. A December 18, 2023, order mandates that fixed-dose combinations of chlorpheniramine maleate IP 2mg and phenylephrine HCl IP 5mg per ml carry explicit warnings against use in children below four years of age. The DCGI has urged all states and Union territories to ensure that testing of raw materials and finished formulations occurs before any product reaches the market, a directive intensified in the wake of the recent fatalities. The Supreme Court is set to hear a Public Interest Litigation (PIL) on Friday seeking a court-monitored investigation into the incidents and broader systemic reform in drug safety mechanisms. The plea calls for the constitution of a National Judicial Commission or Expert Committee, headed by a retired Supreme Court judge, to oversee drug quality and regulatory compliance nationwide.

India, often referred to as the “pharmacy of the world,” ranks as the third-largest producer of drugs by volume, after the United States and China.