Cough syrup deaths in MP: Kerala bans all drugs of Coldrif manufacturer, Respifresh of Rednex

Thiruvananthapuram: After the ban on cough syrup Coldrif, linked to the deaths of 16 children in Madhya Pradesh, the Kerala government on Thursday banned the sale of all drugs manufactured by Sresan Pharmaceuticals, the Tamil Nadu-based company responsible for Coldrif. In addition, Kerala has also banned Respifresh TR, another cough syrup, manufactured by Gujarat-based Rednex Pharmaceuticals Limited. 

"After the Gujarat Drugs Controller intimated that Respifresh TR, 60 ml syrup, was not of standard quality, the state Drug Control Department has ordered the immediate ban on the distribution and sale of the syrup," health minister Veena George said. 

Like in Coldrif, the presence of the hazardous chemical, diethylene glycol (DEG), was detected in Respifresh TR. DEG is a toxic industrial solvent used in antifreeze, paints, brake fluids, and plastics, and can cause severe kidney injury and death. It is not meant to be used in medicines.

Respifresh is a combination of bromhexine hydrochloride, terbutaline sulphate, guaiphenesin and menthol syrup. It had a DEG concentration 11 times the acceptable value.

The minister said that the medicine had five distributors in Kerala. "All of them have been instructed to stop the sale. Violation would invite stringent action," the minister said. Directions have also been issued to initiate strict action against pharmacies selling medicine to children below 12 years without a doctor's prescription.

It was the Food and Drugs Administration (FDA) of Madhya Pradesh that detected the toxic chemical in Respifresh. The FDA had found DEG in yet another syrup called Relife, manufactured by Gujarat-based Shape Pharma Private Limited. The Kerala government has not taken a decision on Relife. Sources said Relife is not distributed in Kerala.

Manorama News reported that the department has collected 44 samples of Coldrif syrup for detailed examination.

The state has also established a three-member expert panel to examine the use of cough medicines in children and has requested that it submit an urgent report. The panel includes the state drugs controller, the child health nodal officer and the state president of the Indian Academy of Paediatrics. Its findings will help formulate new guidelines on the use of cough syrup in children, the minister stated in a press release.

PIL in SC seeks CBI probe
Meanwhile, a PIL has been filed in the Supreme Court seeking an inquiry and systemic reform in drug safety mechanisms in the wake of deaths of children in Madhya Pradesh and Rajasthan, allegedly due to the consumption of toxic cough syrups.

The PIL, filed by advocate Vishal Tiwari, seeks a court-monitored probe into the incidents and urges the constitution of a National Judicial Commission or Expert Committee headed by a retired Supreme Court judge.

The PIL requests that all pending FIRs and investigations concerning the deaths of children caused by toxic cough syrups across states be transferred to the CBI. 

On Tuesday, Madhya Pradesh government confirmed that the death toll in cough syrup related deaths touched 16. The Madhya Pradesh Police has formed a Special Investigation Team (SIT) to investigate the deaths and filed a case against the Tamil Nadu-based manufacturer of Coldrif.