Torrent Pharmaceuticals has clarified that a batch of Shelcal 500 drug that recently failed a Central Drugs Standard Control Organization (CDSCO) test has not been manufactured by the company, and is 'spurious.'
In a recent test, CDSCO had reported that more than 50 drugs were 'not of standard quality', raising concerns over safety. Read More
In August, the CDSCO had prohibited more than 156 fixed-dose combination drugs from the Indian market.
To verify the genuineness of the sample collected by CDSCO, an evaluation was conducted, said Torrent. "The outcome of the analysis concluded that the sample seized by CDSCO is not manufactured by Torrent and is in fact non-genuine and spurious."
Torrent said it has implemented QR codes displaying the batch manufacturing details to verify authenticity, which was found lacking in the seized samples of Shelcal. Torrent has already submitted the response and assessment report to CDSCO.
The list of "not of standard quality" (NSQ) drugs includes popular medicines like antacid Pan D, calcium supplement Shelcal, anti-diabetic drug Glimepiride, high blood pressure drug Telmisartan, among others.
Torrent Pharma has annual revenue of over Rs 10,700 crore, and is India's fifth largest pharma company, with eight manufacturing facilities, of which five are USFDA approved.
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