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Gujarat FDCA seizes 1 tonne of Pregabalin API ‘being traded without licence’

Pregabalin is used in production of medicines used for treatment of various neurological disorders

Investigation into the dealing of this company then took the FDCA investigators to those allegedly manufacturing these APIs. (Facebook/FoodAndDrugsControlAdministrationGujarat)

The Gujarat Food and Drugs Control Administration (FDCA) on Thursday said they have seized 1,000 kg of Active Pharmaceutical Ingredient (API) Pregabalin, used in the production of medicines used for treatment of various neurological disorders, that was being traded in bulk across several firms without any valid licence. The seized API is worth Rs 21.50 lakh, they added.

Gujarat FDCA Commissioner Dr HG Koshia said that M/s Esteem Enterprises, Ahmedabad, which is trading in API, was raided and evidence of sale of 4,300 kg of Pregabalin worth approximately Rs 85 lakh, was found. Investigation into the dealing of this company then took the FDCA investigators to those allegedly manufacturing these APIs.

Pravin Patel, the owner of Axis Pharmachem, and Bhavesh, a partner in Iconic Pharmachem, and others,were found to be manufacturing Pregabalin in their chemical factory in Panoli village of Ankleshwar taluka in Bharuch district, despite not having any kind of licence to manufacture drugs, according to a press note by FDCA.

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Further, the FDCA statement said that testing of this product was conducted by Biochrome Analytical Lab, Ankleshwar, Bharuch, despite not having any kind of licence, and that it was sending test reports to them through WhatsApp without keeping any legal documents.

Upon further investigation in this case, the authorities came to know that M/s Esteem Enterprise, Ahmedabad, had opened a branch in Bharuch and was selling API Pregabalin and other API chemicals without any kind of licence, and was selling API in large quantities, the statement read. Several samples of the API have been sent to the drug-testing lab in Vadodara. Further investigation is underway.

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