Tuesday, 02 January 2024 12:17 GMT

Cough Syrup Deaths: Drug Controller Asks States, Uts To Ensure Strict Testing Of Medicine WHO Seeks Clarification


(MENAFN- Live Mint) Following the tragic deaths of several children linked to contaminated Coldrif cough syrup , the Drugs Controller General of India (DCGI) has issued a directive to all states and Union Territories, emphasising strict compliance with the Drugs Rules, 1945. The order specifically mandates rigorous testing of both raw materials and finished pharmaceutical formulations.

"All the State/ UT Drug Controllers are requested to take measures to ensure testing before the manufacture and release of the batch to the market by way of monitoring during inspections, sensitising the manufacturers through circulars, etc. Further, it shall also be ensured that the manufacturers have a robust vendor qualification system in place and use raw materials, including excipients, from reliable approved vendors only," the DCGI said.

Also Read | Punjab bans Coldrif cough syrup following deaths of children in MP

DCGI chief Rajeev Raghuvanshi previously highlighted serious regulatory failures uncovered during inspections of manufacturing facilities. These checks revealed that drug makers had neglected to test every batch of medicinal ingredients, a critical requirement.

WHO Seeks Clarification

The World Health Organization (WHO), meanwhile, has sought clarification from Indian authorities regarding whether a specific cough syrup , now linked to the deaths of 17 children under the age of five, has been exported to other countries, reported Reuters.

The WHO stated it would assess the need for a Global Medical Products Alert concerning Coldrif syrup once official confirmation is received from India. The UN health agency continues to advise against the use of cough and cold medicines for young children.

Also Read | Madhya Pradesh cough syrup deaths: PIL filed in Supreme Court, seeks CBI probe

According to a government document cited by Reuters, Coldrif, manufactured by Sresan Pharmaceutical Manufacturer, was reportedly sold only within India. Officials in Gujarat also indicated that two other implicated syrups were distributed in other Indian states but did not mention any exports.

The children's deaths, occurring over the past month in India, were attributed to consuming cough medicine found to contain diethylene glycol in concentrations nearly 500 times the permissible limit. All fatalities were linked to the Coldrif medicine, which was officially banned on October 2nd after tests confirmed the presence of the toxic chemical.

In a further development on Wednesday, government authorities issued a public health advisory, urging people to avoid two additional brands of cough syrup: Respifresh and RELIFE. Alerts issued by Gujarat and other states described diethylene glycol as "a toxic chemical that can cause serious poisoning, including kidney failure, neurological complications and even death, especially among children."

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