DCGI Cracks Down On Manufacturers After Fatal Cough Syrup Incident; WHO Weighs Global Alert
The WHO continues to advise against the use of cough and cold medicines for children.
The Drug Controller General of India on Wednesday directed states and Union Territories to strictly comply with the Drugs Rules, 1945, for testing both raw materials and finished formulations.
In a detailed advisory, the DCGI urged all State and UT Drug Controllers to take measures ensuring testing before the manufacture and release of any batch to the market. This includes monitoring during inspections, sensitising manufacturers through circulars, and ensuring that manufacturers maintain a robust vendor qualification system, sourcing raw materials and excipients only from approved and reliable vendors.
Meanwhile, the World Health Organisation has sought clarification from India on whether a cough syrup linked to the deaths of 17 children under the age of five has been exported to other countries, Reuters reported. The UN health agency stated that it will assess the need for a Global Medical Products Alert on Coldrif syrup once it receives official confirmation from Indian authorities.
The WHO continues to advise against the use of cough and cold medicines for children.
Coldrif, manufactured by Sresan Pharmaceutical, was reportedly sold only within India, according to a government document cited by Reuters. Gujarat officials added that two other syrups implicated in the deaths were distributed to other Indian states but did not mention any exports.
The Federation of All India Medical Association had also written to the central government on Wednesday, seeking an immediate and impartial investigation on the matter.
FAIMA, in its letter, expressed "deep concern over the recent reports of unfortunate child deaths" and raised serious questions about the "safety, quality assurance, and monitoring mechanisms governing the manufacture and distribution of pharmaceutical products for children."
The association requested that the Ministry of Health, Medical Education & Family Welfare set up a Central Investigation Committee under the ministry to conduct a detailed and impartial inquiry into the incident, covering all stages of manufacturing, quality testing, and distribution. It said the committee should include qualified medical experts, pharmacologists, and representatives from different states to maintain transparency, neutrality, and multidisciplinary oversight.
