India's drug regulatory authority has launched comprehensive inspections of pharmaceutical manufacturing facilities across six states following a series of child deaths allegedly linked to contaminated cough syrups. The Central Drugs Standard Control Organisation (CDSCO) initiated risk-based inspections on October 3, targeting 19 drug manufacturing units producing cough syrups, antipyretics, and antibiotics.
The inspections cover manufacturing facilities in Himachal Pradesh, Uttarakhand, Gujarat, Tamil Nadu, Madhya Pradesh, and Maharashtra, where the 19 drug samples under investigation were produced. The regulatory action follows reports of child fatalities in Madhya Pradesh and Rajasthan, with at least 11 children confirmed dead and 13 currently receiving treatment for suspected renal failure.
Toxic Contamination Confirmed in Coldrif Syrup
Testing conducted by the Tamil Nadu Food Safety and Drug Administration at the request of Madhya Pradesh authorities revealed alarming contamination levels in Coldrif Cough Syrup manufactured by Sresan Pharma in Kanchipuram, Tamil Nadu. Laboratory results showed Diethylene Glycol (DEG) levels beyond permissible limits in samples collected from the manufacturing facility.
DEG and Ethylene Glycol (EG) are industrial chemicals known to cause severe kidney injury when ingested. The contamination discovery prompted immediate action from Tamil Nadu authorities, who banned the sale of Coldrif syrup statewide and ordered its removal from the market effective October 1.
Inspections were subsequently conducted at Sresan Pharma's manufacturing facility in Sunguvarchathram, Kancheepuram district, with additional samples collected for analysis. The Madhya Pradesh government has requested similar testing of another suspected cough syrup from Himachal Pradesh authorities.
Multi-State Response and Investigation
A multidisciplinary investigation team comprising experts from the National Institute of Virology, Indian Council of Medical Research, National Environmental Engineering Research Institute, CDSCO, and AIIMS-Nagpur continues analyzing samples to determine the exact causes of deaths in and around Chhindwara, Madhya Pradesh.
Initial testing results showed mixed findings. Six samples tested by CDSCO and three by the Madhya Pradesh Food and Drugs Administration were found free of DEG and EG contamination. However, these tested samples were not from the two suspected cough syrups, including Coldrif, which remain under investigation.
Rajasthan authorities have taken decisive action by suspending the state drug controller and halting distribution of all 19 medicines from Jaipur-based Kaysons Pharma. The state has also suspended distribution of all cough syrups containing Dextromethorphan as a precautionary measure. According to the Rajasthan Medical Services Corporation Ltd, over 10,000 Kaysons Pharma drug samples have been tested since 2012, with 42 failing quality standards.
Regulatory Reforms and Safety Measures
The Drug Controller General of India has issued new safety guidelines restricting cough syrup administration to children. The advisory states that cough syrups should only be given to children above five years of age and never to those under two years. The Union Health Ministry's DGHS reinforced these guidelines, emphasizing that cough and cold medications should not be prescribed for children below two years.
For children above five years, healthcare providers must follow careful clinical evaluation, strict dosing protocols, minimal treatment duration, and avoid multi-drug combinations. Drugs potentially harmful to children and pregnant women will now carry clear warning labels as an additional safety measure.
Chief Minister Mohan Yadav of Madhya Pradesh announced the formation of a state-level investigation team and promised strict action against those found guilty. Kerala has also suspended Coldrif syrup sales, though preliminary inquiry revealed the flagged batch was not sold in the state.
Broader Quality Control Concerns
The crisis has exposed systemic issues in pharmaceutical quality control. Separate testing of cough syrups from a Chennai-based company revealed additional adulteration, prompting authorities to halt production and demand explanations from the manufacturer.
In Uttarakhand, joint teams from the health department and Food Safety and Drug Administration are conducting comprehensive raids at medical stores, wholesale drug vendors, and hospital pharmacies across all districts to ensure contaminated products are removed from circulation.
The CDSCO inspections aim to identify gaps that may have led to drug quality failures and suggest process improvements to prevent similar incidents in the future. This regulatory response represents one of the most comprehensive pharmaceutical safety investigations in recent years, highlighting the critical importance of stringent quality control in pediatric medications.
