State issues alert to seize stocks of toxic concoctions

Haryana has ordered the seizure of M/s Sresan Pharma’s Coldrif syrups, allegedly responsible for the death of 14 kids in Madhya Pradesh, and M/s Kaysons Pharma’s Dextromethorphan Hydrobromide syrup, suspected to be behind the death of two children in Rajasthan.

Tamil Nadu has found a batch of Coldrif adulterated with diethylene glycol at a concentration of 48.6 per cent. Kaysons Pharma is under the scanner, though the dextromethorphan-based formulation is not prescribed for pediatric use.

In a communication to all Senior Drugs Control Officers (SDCOs) and Drug Control Officers (DCOs), dated October 5, the State Drug Controller, Haryana, Lalit Goel, has instructed to keep a “strict vigil on the movement” of both the syrups, besides drawing samples as well as seizing “remaining stocks, if found in possession.”

Besides, the State Drug Controller has instructed SDCOs to “inspect manufacturing premises where Propylene Glycol (PG), Sorbitol, etc. are being utilised as ingredients, and to ensure that drug samples containing PG are tested for possible contaminants, so as to verify the presence of DEG/EG impurities, if any.”

He added, “All Assistant State Drugs Controllers must also supervise surprise inspections and raids at both manufacturing and sale premises within their respective areas, with special focus on those units utilising PG, Sorbitol, or similar excipients as solvents.”

M/s Sresan Pharma is based in Kancheepuram, Tamil Nadu, while M/s Kaysons Pharma is based in Jaipur. The batch numbers of both syrups have also been identified and intimated to SDCOs and DCOs.

The SDCOs have been instructed to ensure “strict compliance” with the mandatory guidelines for firms using PG in liquid oral products.

The firms need to purchase pharmaceutical-grade PG from licensed manufacturers or traders in sealed packaging. No loose purchases are allowed. They have been instructed to test PG as per Indian Pharmacopoeia/United States Pharmacopeia (IP/USP) standards before use, specifically for the absence of Diethylene Glycol/Ethylene Glycol (DEG/EG).

Gas Chromatography (GC) test is recommended for checking impurities; firms that frequently use PG are advised to acquire their own GC facility.

“If testing is conducted at an external laboratory, the firm has to ensure the lab provides a test report along with the chromatograph,” said an official of the Food and Drug Administration, Haryana.

The firms have been instructed not to purchase PG from unlicensed dealers. Also, finished products must be tested for the absence of EG/DEG using GC, too.

“Control samples retained by the firm must be regularly checked for EG/DEG. If detected, the product must be immediately recalled from the market,” said an official.

Deadly formulations

*Propylene Glycol is widely used in the preparation of pediatric liquid oral formulations, particularly cough syrups and analgesic syrups

*Both the Indian Pharmacopoeia and the United States Pharmacopeia provide tests for the absence of impurities in Propylene Glycol. The two critical impurities, Diethylene Glycol (DEG) and Ethylene Glycol (EG), are toxic and potentially fatal

Earlier incidents in Haryana

*Maiden Pharmaceuticals, Sonepat, had supplied four cough syrups to the Gambia, which, according to the WHO, had led to the death of 70 children in 2022

*M/s Digital Vision had supplied Cold Best-PC Syrup, which was alleged to be adulterated and caused the death of 12 children in Udhampur in 2020. The firm had provided the stock to an Ambala Cantt-based dealer who further supplied it to Jammu