Cough syrup deaths: TN govt revokes Sresan Pharma’s manufacturing license

The owner, G Ranganathan, of the Sresan Pharma based in Tamil Nadu’s Kancheepuram district was arrested from his Chennai residence last week

The Tamil Nadu government on Monday revoked the license issued to Sresan Pharmaceuticals for manufacturing the contaminated cough syrup, Coldrif, that’s linked to the deaths of 22 children in Madhya Pradesh.

The license to manufacture has been entirely cancelled and the firm has been closed down. (Reuters photo)

“The license to manufacture has been entirely cancelled and the firm has been closed down,” said a statement from the state’s health department.

The owner, G Ranganathan, of the Sresan Pharma based in Tamil Nadu’s Kancheepuram district was arrested from his Chennai residence by a SIT from Madhya Pradesh last week. Tamil Nadu suspended state drug inspectors in Kancheepuram for failing to not inspect the pharma unit after 2022.

After Madhya Pradesh’s drug authority wrote to its counterpart in Tamil Nadu on October 1, the southern state investigated and found contamination after testing samples from the same batch of the cough syrup. Tamil Nadu government then informed Madhya Pradesh, Union Ministry of Health and Family Welfare, and the states where the syrup had been distributed to - Odisha and Puducherry.

The sample tests “found that the alleged batch was manufactured using non-pharmacopoeial grade Propylene Glycol as an excipient, which might have been contaminated with Diethylene Glycol (DEG) and Ethylene Glycol, which are known nephrotoxic and poisonous substances. Tamil Nadu reported 48.6% DEG in samples on October 3 evening—486 times the permissible limit.

The government banned sales immediately after receiving an alert from Madhya Pradesh on October 1 so that private entities do not use the syrup. The Tamil Nadu government has not procured the Coldrif syrup since all government clinics and hospitals procure medicines from the Tamil Nadu Medical Services Corporation (TNMSC).

A “stop production” order was issued by the government to the pharmaceutical company on October 3. On October 5, the Tamil Nadu government issued a notice to the pharmaceutical company, asking why their drug license should not be completely cancelled and demanded a response within 10 days. A show cause notice was issued to Ranganathan and analytical chemist K. Maheswari on October 7.