Premises of five pharma firms in Solan inspected

Five pharmaceutical companies manufacturing Coldrif and Nastro DS cough syrups in Solan district have come under the scrutiny of the drug authorities after seven children in Chhindwara district of Madhya Pradesh died after consuming Coldrif syrup containing toxic industrial chemical diethylene glycol (DEG).

Probe on, sales put on hold

The drug authorities of six states, including Uttar Pradesh where these cough syrups have been sold, have also been directed to put on hold their sale. The firms, too, have alerted their manufacturing chains to suspend the distribution of syrups till the investigation is completed.

Manish Kapoor, State Drugs Controller

This cough syrup was manufactured by Tamil Nadu-based Sresan Pharmaceuticals. Since five firms based in Solan and Baddi also supply these cough syrups to hospitals in Madhya Pradesh, the drug authorities today conducted a risk-based inspection of their manufacturing facilities.

DEG and ethylene glycol (EG) are found as adulterants in propylene glycol (PG) and sorbitol, which are used to manufacture cough syrups. PG and sorbitol are inactive ingredient, used to dissolve active ingredients to manufacture cough syrups and do not have any medicinal value.

State Drugs Controller Manish Kapoor said, “A three-member team comprising a drug inspector from the state drug authority and two from the Central Drugs Standard Control Organisation conducted a risk-based inspection of five firms in Baddi and Solan on Saturday. The team is assessing the status of compliance of their manufacturing facilities as per the revised Schedule M as well as the Good Laboratory Practices (GLP) norms.”

“The CDSCO officials have drawn the samples of two cough syrups, Nastro DS and Coldrif, which are under investigation, and sent them for a laboratory analysis,” Kapoor said.

To ensure public safety, these five firms have given a written undertaking of putting on hold the sale of six oral liquid products manufactured using PG and sorbitol till the lab tests confirm their purity.

“The drug authorities of six states, including Uttar Pradesh where these cough syrups have been sold, have also been directed to put on hold their sale. The firms, too, have alerted their manufacturing chains to suspend the distribution of syrups till the investigation is completed,” said Kapoor.

A probe by the Madhya Pradesh drug authorities revealed that propylene glycol used in the manufacture of the Coldrif cough syrup was of non-pharmaceutical grade and it was neither tested for the presence of DEG and EG and nor for its concentration in violation of the norms.

It was found grossly deficient in compliance with the norms, following which the Tamil Nadu drug authorities stopped the firm’s manufacturing, sale and distribution channels. The presence of DEG in cough syrups has been a contentious issue. In 2020, 12 infants had died and six were rendered disabled after they were given a contaminated cough syrup manufactured by Kala Amb-based Digital Vision. An investigation into the matter had revealed that cough syrups used industrial grade toxic DEG.