Drugs control administration, directorate of health & family welfare (H&FW), has alerted the public about two more cough syrups—Respifresh TR manufactured by Gujarat-based Rednex Pharmaceuticals and Relife, a product of Shape Pharma, also from Gujarat.
In a press release, assistant drugs controller Imlilila stated that as per official communication from FDA, Madhya Pradesh, the drug formulations of Respifresh TR and Relife have been found containing Diethylene Glycol (DEG) impurity above permissible limits and were declared adulterated and Not of Standard Duality.
The drugs control administration state that two mentioned cough syrup formulations contained Diethylene Glycol (DEG)—a toxic chemical that can cause serious poisoning, including kidney failure, neurological complications, and even death, especially among children.
Therefore, the drugs control administration has strictly prohibited the sale or distribution of Respifresh TR (Batch No RO1GL2523) and Relife (Batch No LSL25160) with immediate effect.
It has also directed retailers, wholesalers, distributors, hospitals, and medical practitioners across Nagaland not to sell, distribute, prescribe, or use the above mentioned batches. Concerned licensees of Nagaland have been directed to report any stock or supply details to the respective drugs control officers of their jurisdiction immediately.
WHO seeks clarification on cough syrup
NEW DELHI, OCT 9 (PTI): The World Health Organisation has sought to know from Indian authorities whether the cough syrup linked to child deaths in the country was exported to other nations, sources said on Thursday.
They said the global health agency will take a call on issuing a ‘Global Medical Products Alert’ on the cough syrup, Coldrif, after receiving an official confirmation from authorities here. The agency issues such alerts for substandard and contaminated medicines.
Five children from Madhya Pradesh are in a critical condition, while 20 have died due to kidney infections caused by the consumption of the “contaminated” cough syrup, containing Diethylene Glycol (DEG) and Ethylene Glycol (EG).
Besides, at least three children have allegedly died in Rajasthan after consuming cough syrup in different districts of the state. “The World Health Organisation (WHO) on Wednesday has asked for a clarification on whether the cough syrup linked to children deaths in the country was exported to other countries as part of the routine process”, the sources said.
WHO stated that it is closely monitoring recent media reports from India regarding clusters of pediatric illnesses and deaths in Madhya Pradesh and Rajasthan.
The WHO has not received any official information as to the source of the DEG contamination or if contaminated pharmaceutical material has been identified, sources said.
The global health agency has expressed deep concern over the developments and emphasized the potential risk of contaminated products being exported to other countries, particularly via unregulated channels and the regulatory gap in DEG/EG screening for domestically marketed medicines in India. It has also stressed on identifying the source of the contamination and identifying and removing any contaminated pharmaceutical material which may be in circulation, the sources said.
3 cough syrups recalled, says CDSCO: Central drug regulator CDSCO has informed the World Health Organisation (WHO) that three cough syrups — Coldrif, RespifreshTR and ReLife — have been recalled and manufacturers have been ordered to stop their production.
CDSCO on Wednesday informed the global health agency that none of the products were exported from India, official sources said. CDSCO launches pan India drive to test cough syrup manufacturers: Central drug regulator CDSCO has started a pan India drive to test, inspect and audit cough syrup manufacturers, official sources said on Thursday.
It has also asked all states and Union territories to provide a list of cough syrup manufacturing companies for auditing.