Now, Gujarat-made syrups under scanner

After issuing instructions for the seizure of stocks of two cough syrups, which caused the death of kids in Madhya Pradesh and Rajasthan, State Drug Controller Lalit Goel issued fresh orders for the seizure of two more cough syrups, manufactured in Gujarat.

As per the instructions issued today, Bromhexine Hydrochloride, Terbutaline Sulphate, Guaiphenesin & Menthol Syrup (Respifresh TR), manufactured by M/s Rednex Pharmaceuticals in Ahmedabad; and Ambroxol HCL, Guaiphenesin, Terbutaline Sulphate & Menthol Syrup (Relife), manufactured by M/s Shape Pharma, are under the scanner.

These drug formulations have been found to contain Diethylene Glycol (DEG) impurity above permissible limits and are declared adulterated. It is a toxic chemical that can cause serious poisoning.

The Senior Drug Control Officers (SDCOs) and Drug Control Officers (DCOs) have been directed to “maintain strict vigil on the movement” of these drugs and “to draw samples as well as seize remaining stock if found in possession.” Madhya Pradesh and Gujarat have shared information with Haryana.

In Bromhexine Hydrochloride, Terbutaline Sulphate, Guaiphenesin & Menthol Syrup (Respifresh TR), the Diethylene Glycol was found at 1.342 percent, which was more than the permissible value (0.1%) while Ethylene Glycol was absent. Four samples were taken.

In Ambroxol HCL, Guaiphenesin, Terbutaline Sulphate & Menthol Syrup (Relife), the Diethylene Glycol was found at 0.616 percent, which was more than the permissible value (0.1%). However, Ethylene Glycol was absent. Here too, four samples were taken.

Propylene Glycol is widely used in the preparation of pediatric liquid oral formulations, particularly cough syrups and analgesic syrups. Both the Indian Pharmacopoeia and the United States Pharmacopeia provide tests for the absence of impurities in Propylene Glycol. The two critical impurities, DEG and Ethylene Glycol (EG), are potentially fatal.

Earlier, on October 5, the State Drug Controller had issued orders for the seizure of M/s Sresan Pharma’s Coldrif syrups, allegedly responsible for the death of 19 kids in Madhya Pradesh, and M/s Kaysons Pharma’s Dextromethorphan Hydrobromide syrup, suspected to be behind the death of two kids in Rajasthan. Nine more kids are on a life support system in Chhindwara, Madhya Pradesh.

Meanwhile, the Ministry of Health and Family Welfare has advised that cough and cold medications should not be prescribed or dispensed to children under two years of age.