KOHIMA, OCTOBER 9 (MExN): The Directorate of Health & Family Welfare, Drugs Control Administration, Nagaland, has issued a public alert following an official communication from the Food and Drug Administration (FDA), Madhya Pradesh, regarding two cough syrup formulations found to contain Diethylene Glycol (DEG) impurity above permissible limits.
According to the notification, the affected drugs are declared adulterated and “Not of Standard Quality.” The identified formulations are:
1. Respifresh TR (Bromhexine Hydrochloride, Terbutaline Sulphate, Guaiphenesin & Menthol Syrup) — Batch No. RO1GL2523, Expiry Date: December 2026, manufactured by M/s. Rednex Pharmaceuticals Pvt. Ltd., Survey No. 586 & 231, near SKF Bearing, Bavla, Bagodara, N.H. 8A, Taluka Bavla, District Ahmedabad, Gujarat-383220.
2. Relife (Ambroxol Hydrochloride, Guaiphenesin, Terbutaline Sulphate & Menthol Syrup) — Batch No. LSL25160, Expiry Date: December 2026, manufactured by M/s. Shape Pharma Pvt. Ltd., Plot No. 4, Sundernagar, Rajkot Highway Road, Shekhpur, Gujarat-363510.
The alert warned that Diethylene Glycol (DEG) is a toxic chemical that can cause severe poisoning, including kidney failure, neurological complications, and even death, particularly among children.
“The sale or distribution of these batches is strictly prohibited with immediate effect,” stated the notice issued by the Assistant Drugs Controller.
Retailers, wholesalers, distributors, hospitals, and medical practitioners across the state have been instructed not to sell, distribute, prescribe, or use the affected batches. All concerned licensees in Nagaland are directed to report any stock or supply details to the respective Drugs Control Officers of their jurisdiction immediately.
