CDSCO launches inspections of drug manufacturing units in six states after cough syrup deaths

NEW DELHI: The Central Drugs Standard Control Organisation (CDSCO) has initiated risk-based inspections of drug manufacturing units in six states following the collection of 19 samples, including cough syrups, antipyretics, and antibiotics, in the wake of child deaths in Madhya Pradesh and Rajasthan allegedly linked to contaminated cough syrups. The inspections cover manufacturing units in Himachal Pradesh, Uttarakhand, Gujarat, Tamil Nadu, Madhya Pradesh, and Maharashtra, where the 19 drug samples were produced, sources in the health ministry said. The aim of the inspections, which began on Friday, is to identify gaps that may have led to drug quality failures and to suggest process improvements to prevent such incidents in the future, the ministry added. A multidisciplinary team comprising experts from the National Institute of Virology, Indian Council of Medical Research, National Environmental Engineering Research Institute, CDSCO, and AIIMS-Nagpur continues to analyse the samples to assess the causes of deaths in and around Chhindwara, Madhya Pradesh. So far, six samples tested by CDSCO and three by the Madhya Pradesh Food and Drugs Administration (MPFDA) were found free of Diethylene Glycol (DEG) and Ethylene Glycol (EG), chemicals known to cause severe kidney injury. However, these tested samples were not from the two suspected cough syrups, including Coldrif, which remain under investigation. At the request of the Madhya Pradesh government, the Tamil Nadu Food Safety and Drug Administration tested Coldrif syrup samples from the Sresan Pharma facility in Kanchipuram, Tamil Nadu. The results showed DEG levels beyond permissible limits, leading the Tamil Nadu government to ban the sale and order removal of the syrup from the market. Inspections were also conducted at Sresan Pharmas manufacturing facility in Sunguvarchathram, Kanchipuram district, with samples collected for analysis. The Madhya Pradesh government has also requested Himachal Pradesh authorities to test the other suspected cough syrup. On Saturday, the Madhya Pradesh government banned Coldrif syrup, following reports of nine child deaths due to suspected renal failure since September 7. Currently, 13 children, including eight from Chhindwara and Nagpur, are undergoing treatment. Chief Minister Mohan Yadav stated that the sale of Coldrif and other products from the manufacturer has been banned, a state-level investigation team has been formed, and strict action will be taken against the guilty. Kerala has also suspended the sale of Coldrif syrup following concerns raised by other states, though preliminary inquiry revealed the flagged batch was not sold in the state, Kerala Health Minister Veena George clarified. Separately, tests on cough syrups from a Chennai-based company found adulteration, prompting authorities to halt production and demand explanations. In Rajasthan, the state has suspended the drug controller and halted distribution of all 19 medicines from Jaipur-based Kaysons Pharma, following the deaths of 11 children (nine in Madhya Pradesh and two in Rajasthan) allegedly linked to contaminated syrups. Distribution of all other cough syrups containing Dextromethorphan has also been suspended. An expert committee is being constituted to investigate the issue. The Drug Controller General of India advised that cough syrups should only be given to children above five years, and never to those under two years. Drugs potentially harmful to children and pregnant women will now carry clear warning labels. In Uttarakhand, joint teams from the health department and Food Safety and Drug Administration are conducting raids at medical stores, wholesale drug vendors, and hospital pharmacies across all districts. According to the Rajasthan Medical Services Corporation Ltd (RMSCL), over 10,000 Kaysons Pharma drug samples have been tested since 2012, with 42 failing quality standards. As a precaution, the supply of all 19 medicines from the company has been suspended. The Union Health Ministrys DGHS issued an advisory stating that cough and cold medications should not be prescribed for children below two years. For children above five, usage should follow careful clinical evaluation, strict dosing, minimal duration, and avoidance of multi-drug combinations.