Torrent Pharmaceuticals has clarified that a batch of popular calcium and vitamin D supplement Shelcal 500 that recently failed a Central Drugs Standard Control Organisation (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.
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,” it said.
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.
“Our assessment of the authenticity of samples, including physical appearance, QR code, and labelling text comparison, establishes that the NSQ sample is non-genuine and counterfeit, whereas our controlled sample matches with pre-defined specifications,” Torrent added.
Torrent has submitted a formal response along with an assessment report, concluding that the seized sample is spurious, 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, and high blood pressure drug Telmisartan.
Comments
0 comment