Drugs regulator plans stricter norms on DEG in cough syrups

The national drugs regulator is working on stricter rules related to the presence of Diethylene Glycol (DEG) in cough syrups that will be made public in a week or so for the reference of manufacturers across the country, according to people familiar with the matter, adding those found flouting the rules will face strict punishment including criminal proceedings.

- Rhythma Kaul

It will also embark, along with state drug regulators, on an audit of all cough syrup manufacturers across the country, many of which are small enterprises such as Tamil Nadu’s Sresan Pharmaceuticals, the maker of the cough syrup that killed 20 children in Madhya Pradesh. To be sure, current rules prescribe an upper limit of 0.1% for DEG as well as Ethylene Glycol (EG), two contaminants commonly found in cough syrups, and mandate testing of all raw materials or the presence of DEG/EG. But adherence and monitoring are both lax. Sresan’s Coldrif had 48.6% DEG.

“The Central Drugs Standard Control Organisation (CDSCO) is working with internal experts to come up with stricter norms for use of DEG and EG in cough syrups. These are going to be a comprehensive set of norms and any violation will have severe ramifications,” said a government official, requesting anonymity.