CDSCO Flags 53 Medications for Quality Issues: Torrent Pharma Responds to Shelcal 500 Concerns

Date: 2024-09-27
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The Central Drugs Standard Control Organization (CDSCO) has flagged 53 commonly prescribed medications as failing to meet quality standards, including notable products like Shelcal 500, a calcium supplement marketed by Torrent Pharmaceuticals. In its latest monthly report, CDSCO identified these medications, which include Glimepiride for diabetes, Telmisartan for hypertension, and the antacid Pan D, as being of substandard quality. This list is particularly concerning as it includes essential medications from prominent pharmaceutical companies such as Hetero Drugs, Torrent Pharma, Alkem Laboratories, Hindustan Antibiotics Limited (HAL), and Karnataka Antibiotics & Pharmaceuticals Ltd.

Specifically regarding Shelcal 500, produced by Pure & Cure Healthcare in Uttarakhand and marketed by Torrent Pharma, the company asserts that the sample seized by CDSCO was not manufactured by them and is counterfeit. Recent media reports from CDSCO East Zone in Kolkata have highlighted a batch (GDXD0581) of Shelcal 500 that has been labeled as Not of Standard Quality (NSQ), alongside other pharmaceuticals.

To verify the authenticity of the confiscated sample against their controlled batch sample from the same production run, Torrent conducted a comparative analysis. The results indicated that the seized sample was indeed counterfeit and not produced by Torrent. To combat counterfeiting issues more effectively, Torrent has implemented QR codes on their Shelcal products to provide batch manufacturing details—information that was absent in the confiscated sample.

The company emphasized that their examination process included assessing physical characteristics alongside QR code validation and label text comparison to confirm that their controlled samples met all established standards while categorizing the NSQ samples as fraudulent. Furthermore, Torrent stated they had previously communicated with CDSCO regarding this matter with an official response and assessment report labeling the seized product as fake. They reiterated their commitment to rigorous quality control processes for each production batch.

Torrent Pharma operates within various therapeutic areas such as Cardiovascular (CV), Gastrointestinal (GI), Central Nervous System (CNS), Vitamins Minerals Nutritionals (VMN), and Cosmo-Dermatology. It ranks fifth in India's pharmaceutical market and derives approximately 75% of its revenue from chronic and sub-chronic treatment segments within India. The company assures adherence to Good Manufacturing Practices (GMP) across all products produced and distributed under its name according to established regulatory guidelines.

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