Central Drugs Standard Control Organization (CDSCO) has flagged 53 commonly used medicines for failing quality tests in the latest monthly drug alert. Some of the top-selling commonly used medicines like Antacid Pan D, calcium supplement Shelcal, anti-diabetic drug Glimepiride, high blood pressure drug Telmisartan and many more have failed the quality test.
According to the alert, more than 50 drugs have been declared Not of Standard Quality (NSQ) or substandard. The list holds importance due to the failure of critical, essential medicines manufactured by several top pharma firms, including Torrent Pharma, Hetero Drugs, Alkem Laboratories, Hindustan Antibiotics Limited (HAL), Karnataka Antibiotics & Pharmaceuticals Ltd. etc.
Shelcal, sold by Torrent Pharmaceuticals and manufactured by Uttarakhand-based Pure & Cure Healthcare, has also failed the test. Meanwhile, Torrent claimed that the sample seized by CDSCO is “not manufactured by Torrent and is in fact non-genuine and spurious.”
“Recent articles have been issued in media with reference to the Central Drugs Standard Control Organization (CDSCO) East Zone, Kolkata report referring to one batch (GDXD0581) sample of Product Shelcal 500, amongst other drugs marketed by various pharmaceutical companies, allegedly being non-standard quality (NSQ).To verify the genuineness of the sample collected by CDSCO, a comparative evaluation was carried out with our controlled sample of the same batch. 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,” the company said in a statement shared over e-mail.
As anti-counterfeit measures, Torrent has implemented QR codes on Shelcal, displaying batch manufacturing details to verify its authenticity, which was found to be lacking in the sample seized by CDSCO, the company highlighted.
“Our assessment of establishing 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 has already submitted a formal response along with assessment report, concluding the seized sample as spurious to CDSCO,” the pharmaceutical firm maintained.
According to the company, each and every batch manufactured is also subjected to strict quality testing. “We assure that all products manufactured and marketed by Torrent follow Good Manufacturing Practices (GMP) and are controlled through pre-established specifications and/or regulatory norms,” it added.
This month, CDSCO has posted two different lists — one with products of big pharma companies and their replies and the other a regular list.
Torrent Pharma is ranked 5th in the Indian Pharmaceuticals Market and is amongst the Top 5 in the therapeutics segments of Cardiovascular (CV), Gastro Intestinal (GI), Central Nervous System (CNS), and Vitamins Minerals Nutritionals (VMN) and Cosmo-Dermatology. It is a specialty-focused company with ~75% of its revenues in India from chronic & sub- chronic therapies.