The Haryana Food and Drugs Administration (FDA) has busted a counterfeit pharmaceutical-grade chemical racket in Faridabad.
Additional chief secretary (health) Sumita Misra said that the seized consignment could have posed a life-threatening risk to consumers of cough syrups and other pharmaceutical formulations. Propylene glycol is widely used as an excipient in the manufacture of cough syrups and several other pharmaceutical formulations, making its quality and purity critical for patient safety.
Misra said the crackdown comes under the department’s zero tolerance policy against the manufacture, distribution and sale of spurious and counterfeit medicines.
She said that to the best of the department’s knowledge, this is the first case in India involving alleged counterfeiting and repackaging of pharmaceutical-grade propylene glycol under the brand identity of an established manufacturer. The ACS said that contamination of propylene glycol with diethylene glycol (DEG) or ethylene glycol (EG) has been linked to deaths reported in Madhya Pradesh and Rajasthan in recent months.
FDA officials said that on July 28, teams from Faridabad raided the premises of M/s Kokana Asia Ingredients Private Limited in IMT, Faridabad, following a specific complaint about counterfeit propylene glycol.
Officials said the inspection exposed an alleged repackaging operation in which industrial-grade propylene glycol was being decanted into drums bearing the labels and markings of M/s Manali Petrochemicals Limited, passing off the product as genuine output of the established manufacturer. The raiding team seized 42 drums of propylene glycol, empty Chinese-origin industrial-grade propylene glycol drums, a transfer pump, sealing covers carrying the Manali Petrochemicals name, and sealing wire under Form-16, while one sample was drawn under Form-17 for laboratory analysis. The total seizure amounted to about ₹24.83 lakh.
{{/usCountry}}Officials said the inspection exposed an alleged repackaging operation in which industrial-grade propylene glycol was being decanted into drums bearing the labels and markings of M/s Manali Petrochemicals Limited, passing off the product as genuine output of the established manufacturer. The raiding team seized 42 drums of propylene glycol, empty Chinese-origin industrial-grade propylene glycol drums, a transfer pump, sealing covers carrying the Manali Petrochemicals name, and sealing wire under Form-16, while one sample was drawn under Form-17 for laboratory analysis. The total seizure amounted to about ₹24.83 lakh.
{{/usCountry}}The ACS said that the samples have been sent for testing to determine whether it contains diethylene glycol or ethylene glycol impurities beyond permissible limits. Contamination of this kind, Misra said, can trigger severe toxicity, including acute kidney injury and neurological complications, and can prove fatal particularly among children and other vulnerable patients.
Citing prima facie evidence of the manufacture and sale of spurious and counterfeit drugs, officials confirmed that the firm’s manager was arrested under the applicable provisions of the Drugs and Cosmetics Act, 1940, and produced before the competent court for further legal proceedings.