New Delhi: Following the tragic deaths of 20 children in Madhya Pradesh, allegedly due to consumption of contaminated Coldrif cough syrup, the Drugs Controller General of India (DCGI) has issued a nationwide directive to ensure strict compliance with drug testing regulations.

In a letter dated October 7, Dr Rajeev Singh Raghuvanshi, the DCGI, instructed all State and Union Territory Drug Controllers to rigorously enforce provisions under the Drugs Rules, 1945, specifically relating to the testing of raw materials and finished pharmaceutical formulations.

Directive following child deaths in Madhya Pradesh

The order comes in the wake of disturbing reports from Chhindwara district, where multiple child deaths have been allegedly linked to the consumption of Coldrif cough syrup, manufactured by a Tamil Nadu-based pharmaceutical company.

“There have been recent reports of child deaths in Chhindwara, Madhya Pradesh, allegedly linked to contaminated cough syrups and concerns related to the quality of these cough syrups,” the DCGI stated in his letter.

According to officials, 20 children have lost their lives so far — 17 in Chhindwara, two in Betul, and one in Pandhurna — while five others remain under treatment. The incident has sparked widespread concern about the quality control measures in India’s pharmaceutical manufacturing sector.

Inspections reveal major lapses in drug testing

The DCGI’s letter highlights serious deficiencies in compliance among certain manufacturers. Inspections conducted at multiple pharmaceutical plants revealed that some companies were failing to carry out proper testing of raw materials and inactive ingredients, known as excipients, before production.

“During the inspections and investigations of drugs declared as Not of Standard Quality, it was observed that manufacturers are not testing each batch of excipients and active pharmaceutical ingredients for compliance with prescribed standards before using them in formulations,” the letter said.

Such failures, the DCGI warned, pose a direct risk to public health, particularly in the case of paediatric medicines, where safety and purity are paramount.

Mandatory testing before production

To prevent such incidents from recurring, the DCGI has mandated that all licensed pharmaceutical manufacturers test raw materials and excipients either in their own laboratories or in approved testing facilities before use in production.

Every manufacturer must also maintain detailed records of test results as outlined under Schedule U of the Drugs Rules, ensuring complete traceability of all batches produced.

The directive further instructs state and UT regulators to monitor compliance through regular inspections and sensitise manufacturers via circulars and advisories.

“It shall be ensured that manufacturers have a robust vendor qualification system in place and use raw materials, including excipients, only from reliable, approved vendors,” the DCGI added.

World Bank’s technical assistance to drug regulators under discussion

While the DCGI’s immediate focus remains on enforcing domestic drug safety standards, sources within the Central Drugs Standard Control Organisation (CDSCO) have indicated that talks are underway for technical cooperation with international agencies, including the World Bank, to modernise drug testing infrastructure and surveillance systems.

This development follows several global alerts over the past two years concerning substandard cough syrups exported from India, which were linked to child fatalities in countries such as Gambia and Uzbekistan. The latest incident in Madhya Pradesh has renewed pressure on regulators to tighten quality control at every stage of production.

Arrest of manufacturer’s owner

Meanwhile, police have arrested S. Ranganathan, the owner of the Tamil Nadu-based company that produced Coldrif cough syrup. According to Chhindwara Superintendent of Police, Ranganathan was taken into custody on Thursday and will be presented before a Chennai court for transit remand before being brought to Chhindwara for further investigation.

Authorities are examining whether the cough syrup contained toxic levels of diethylene glycol (DEG) or ethylene glycol (EG) — contaminants that have previously caused mass poisonings in similar cases worldwide.

Government response and public health concerns

Madhya Pradesh Deputy Chief Minister and Health Minister Rajendra Shukla confirmed the deaths on Wednesday, stating that all possible measures are being taken to ensure accountability. “Twenty children have died, and five are under treatment. The government has ordered a thorough inquiry and all samples are being tested at accredited laboratories,” he said.

Public health experts have called for stricter enforcement of Good Manufacturing Practices (GMP), routine audits, and enhanced transparency in pharmaceutical supply chains to prevent such tragedies.

“The issue is systemic,” said a senior pharmacologist based in Delhi. “Testing cannot be an afterthought. Every input that goes into a medicine must be verified and validated. This is a wake-up call for the industry.”

Conclusion

The DCGI’s directive underscores a renewed national focus on drug safety and regulatory accountability following the Madhya Pradesh tragedy. As the investigation continues, it highlights the urgent need for India’s pharmaceutical sector to prioritise quality assurance and ethical manufacturing practices.

With stronger testing protocols, improved oversight, and greater vigilance from both regulators and manufacturers, authorities hope to prevent another disaster of this scale and restore public trust in India’s medicines.