The World Health Organization (WHO) has also sought clarification from the Central Drugs Standard Control Organisation
| Photo Credit:
Daniel Heighton
As the death toll from possibly consuming contaminated cough syrup inches up to 20 children in Madhya Pradesh, States are acting against two more cough syrups said to be involved in the incident.
Questions are being asked by the Centre about the regulatory process that did not catch the contaminated syrups from Tamil Nadu-based Sresan Pharma before it was supplied. The World Health Organization (WHO) has also sought clarification from the Central Drugs Standard Control Organisation (CDSCO) on whether the contaminated products were exported.
On Wednesday, Telangana’s Drug Control Administration directed people to stop consuming Relife and Respifresh TR, adulterated with the toxic substance Diethylene Glycol (DEG). Relife is manufactured by Shape Pharma and Respifresh is by Rednex Pharmaceuticals — both Gujarat-based manufacturers. This comes a day after Gujarat authorities banned the two syrups.
WHO inquiry
In a separate development, the WHO confirmed to businessline, it had contacted the CDSCO “for information on these events, including clarification regarding potential links to contaminated medicines and whether the products were exported to other countries.” The UN health agency said, it had received a response from the Indian authorities. Details of this response are awaited, while going to press. .
Expressing “deep concern”, the WHO reiterated the importance of screening all suspect samples for DEG and ethylene glycol (EG), besides expressing concern about the regulatory gap in DEG/EG screening for domestically marketed medicines in India. Cough syrups made in India were linked to potential deaths in Gambia and other countries just years ago.
Meanwhile, the CDSCO urged drug controllers in States and UT to ensure the testing of raw materials and finished formulations. Referring to the Madhya Pradesh child deaths, allegedly from contaminated cough syrups, the CDSCO said, “During the inspections carried out at the manufacturing facilities and in the investigations of the drugs declared as Not of Standard Quality, it was observed in the reports that the manufacturers are not carrying out testing of each batch of the excipients/inactive and active pharmaceutical ingredients for verification of compliance with the prescribed standards before using them in the manufacture of formulations and also in the finished products.”
Citing Drugs Rules rule 74 (c) and rule 78 (c) (ii), the CDSCO said, it mandated the licensee to “either in his own laboratory or in any laboratory approved by the licensing authority test each batch or lot of the raw material used by him for the manufacture of his product and also each batch of the final product,” besides maintaining records or registers showing details of these tests.
Reports said that the Sresan Pharma unit has been sealed and authorities were on the look out for its owner.
Doctors have been vocal on the incident as well, especially with the arrest of a paediatrician in Madhya Pradesh. In a letter to the Union Health Minister, JP Nadda, Dr Dilip Bhanushali, National President with the Indian Medical Association (IMA) called for “the immediate withdrawal of the case against the bona fide medical practitioner, and focus the investigative and enforcement resources on the manufacturer and the regulatory bodies whose institutional failure led to this tragic loss of life.”
Published on October 8, 2025