Pantoprazole Sodium Hydrate

New Delhi: India’s drug regulator, the Central Drugs Standard Control Organization (CDSCO), identified 185 drug samples as ‘ Not of Standard Quality ’ (NSQ) and flagged four others as ‘spurious’ during its monthly quality review for June. Of the total NSQ samples, 55 were flagged by Central Drugs Laboratories , while the remaining 130 were reported by State Drugs Testing Laboratories. In addition, the CDSCO drug alert identified four spurious drug samples, including a Cefixime Tablet from Bihar, an ointment of Heparin Sodium and Benzyl Nicotinate from Delhi, and two samples of Rosuvastatin and Fenofibrate Tablets — Rosuvas F 10 and Rosuvas F 20—collected from Telangana. A drug is deemed spurious if it qualifies certain conditions detailed under Section 17-B of the Drugs and Cosmetics Act, 1940. Of the 55 samples flagged as NSQ by central testing laboratories includes Dextrose Injection manufactured by Tam-Bran Pharmaceuticals; Azithromycin Tablet by Apple Formulations; Paracetamol Intravenous Infusion by D.J. Laboratories Telmisartan Tablets by Healers Lab and 51 other samples. The 130 samples flagged by state laboratories includes several common medicines and supplements such as Paracetamol, Pantoprazole, Calcium , Vitamin D3 tablets and several other common drugs. The identification of drug samples as NSQ is done based on failure of the drug sample in one or the other specified quality parameters and the term NSQ has been defined under Section 16(1)(a) of the Drugs and Cosmetics Act, 1940. However, according to the Health Ministry, “identification of drug samples as 'NSQ' does not warrant any concerns on the other drug products available in the market. The CDSCO routinely notifies ‘'NSQ ' and spurious medicines based on a monthly review undertaken by the central and state drug regulatory bodies to ensure that these drugs are removed from the market and enforce quality norms. By Abhijeet Singh ,

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 ,