Pantoprazole Sodium Hydrate

Mumbai: Haffkine Bio-Pharmaceuticals procurement cell will be seeking explanations from two pharmaceutical firms after it came to light that medicines ordered for govt hospitals across the state in Feb had been declared "not of standard quality" and blacklisted by Employees' State Insurance Corporation (ESIC) just two months earlier. In Dec, ESIC issued a circular blacklisting specific drugs from seven pharmaceutical companies, citing test results that found these medicines to be of substandard quality and directing that no further orders be placed with them. However, Haffkine Bio-Pharmaceuticals placed large supply orders with two of the listed firms. This resulted in the procurement of nearly 21.9 lakh vials of Pantoprazole 40mg/10ml injection worth Rs 2.5 crore from Galpha Laboratories Ltd, and 88,650 tablets of Vildagliptin 50mg, along with Metformin Hydrochloride 1000mg worth nearly Rs 12.6 lakh, from Bajaj Healthcare Ltd. Pantoprazole is used to treat acid-related stomach issues such as ulcers and acid reflux, while Vildagliptin with Metformin is prescribed to manage type 2 diabetes by controlling blood sugar levels. Although Haffkine is no longer the primary authority for medicine procurement, it was granted permission to utilise the remaining Rs 131.6 crore to restock medicines at state-run hospitals through a Govt Resolution (GR). "The procurement process must be based on ESIC rate contracts as received on the e-Aushadhi platform," the GR stated. A senior official at the procurement cell confirmed that they are looking into the matter. "We have been orally informed by ESIC that the issue pertained to specific batches. Nevertheless, we have sought written responses from the companies as well as from ESIC. These will be submitted to higher authorities, and payments to the companies will be withheld until a reasonable explanation is provided," the official said, but did not provide the amount of payments to be withheld. Abhay Pandey, of the All Food and Drug Licence Holders Foundation, who flagged the issue with medical education department officials, alleged that the existing rate contract was arbitrarily selected by Haffkine without verifying the blacklisting status of the companies or conducting additional tests on the medicines. Haffkine officials did not respond when asked whether random sampling of the procured products was conducted in accordance with the GR. Dr Shashi Kolnoorkar, state ESIC director (Medical), said the blacklisting order came from the Delhi headquarters and that appropriate action had been taken at the time. When asked whether the blacklisting applied to specific batches or constituted a complete ban on the medicines in question, he referred the query to the ESIC head office. Attempts were made to reach Dr Neeta Garbiyal, deputy medical commissioner at the ESIC head office, who had signed the blacklist circular, but she was unavailable for comment. By Eshan Kalyanikar ,

New Delhi: During the routine quality review check in March, a total of 131 drug samples failed to meet the quality standards, while one sample of the popular hypertension brand Telma 40 has been flagged as spurious. The monthly drug quality review alert issued by the Central Drugs Standard Control Organization (CDSCO) flagged 131 drug samples as “ Not of Standard Quality ” (NSQ) and one sample as “spurious.” Making the announcement, the Union Health Ministry informed that of the total 131 NSQ samples, 70 were identified by the Central Drugs Laboratories and the remaining 61 samples were identified by the State Drugs Testing Laboratories. In addition to this, one drug sample flagged as spurious is of popular hypertension brand “Telma 40 (Telmisartan Tab I.P. 40mg),” manufactured in February 2024 and was plucked by the regulators from West Bengal. As per the Union Health Ministry, “the spurious sample was manufactured by an unauthorized manufacturer using a brand name owned by another company, and currently the matter is under investigation.” In its remark, the apex drug regulator CDSCO has said, “the product is purported to be spurious, however, the same is subject to the outcome of investigation.” Notably, last month a separate batch of the same brand picked from West Bengal was flagged as spurious. The sample was manufactured in 2022, and the reason for the drug test failure was notified as the sample “does not conform to I.P.” Telma (Telmisartan) is an angiotensin II receptor blocker that decreases high blood pressure and has been commercially marketed in India for the past two decades. The branded generic drug is marketed by Glenmark and, as per an analysis from market research firm Pharmarack, it features among the top 20 brands in the country, with a moving annual total (MAT) value of around ₹483 crore. The NSQ drug samples flagged by the central drug laboratories in March include Pantoprazole manufactured by Kolkata-based Shangrila Industries; Albendazole tablets by Mumbai-based Digital Vision; Telmisartan tablets manufactured by Guwahati-based Swiss Garnier Life Sciences; among 67 others. While the NSQ samples identified by state drug testing laboratories include Norfloxacin tablets manufactured by Revat Laboratories; Glimepiride tablets by Kerala State Drugs and Pharmaceuticals; Sucralfate by Legend Industries; among 58 others. Under Section 17-B of the Drugs and Cosmetics Act, 1940, a drug shall be deemed spurious if it is manufactured under a name belonging to another drug; an imitation of, or a substitute for, another drug; resembles another drug in a manner likely to deceive; or if it bears upon its label or container the name of another drug, among several other provisions. For NSQ samples, the drugs that fail to meet quality standards or specifications are notified as NSQ, a term defined under Section 16(1)(a) of the Drugs and Cosmetics Act, 1940. By Online Bureau ,