Prescribed drugs to treat type-2 diabetes and a gastro-resistant tablet manufactured by Maiden Pharmaceuticals Ltd, a Delhi-based company with its manufacturing unit in Haryana’s Sonepat district, were among drugs found to be of poor quality during laboratory tests in Kerala on at least five occasions in the past nine months.
According to Xtended Licensing and Laboratory Node (XLN), a web portal of the central government, a sample of Metomin tablets containing Metformin (for treating diabetes) from a primary health centre in Kerala’s Ernakulam district was found to be of substandard quality by a food and drugs laboratory (FDL) on September 28.
“The sample does not conform to Indian Pharmacopoeia (IP) 2018. This particular batch of sample fails the dissolution test. Hence declared not of standard quality,” the laboratory’s remarks on the XLN website said. Calls made to Maiden Pharmaceutical’s Delhi offices did not elicit a response.
Indian Pharmacopoeia is published on behalf of the Union health ministry and is recognised as an official book prescribing standards for drug manufacturing or marketing in the country. It contains details of authoritative procedures of analysis and specifications of drugs for their purity, strength and identity. The IP standards are legally acceptable during quality assurance and recognised at the time of legal disputes.
Similarly, a sample of Easiprin tablets, a gastro-resistant Aspirin drawn from Taluk headquarter hospital in Karimbam, in Kerala’s Kannur, were tested on June 30 and was not found in compliance with IP standards. The tablets manufactured at the Sonepat facility were marketed by Kerala Medical Services Corporation.
{{/usCountry}}Similarly, a sample of Easiprin tablets, a gastro-resistant Aspirin drawn from Taluk headquarter hospital in Karimbam, in Kerala’s Kannur, were tested on June 30 and was not found in compliance with IP standards. The tablets manufactured at the Sonepat facility were marketed by Kerala Medical Services Corporation.
{{/usCountry}}A sample of Maical-D tablets drawn from taluk hospital in Thiruvananthapuram’s Attingal municipality and tested at the FDL on March 24, 2022, was also found to be “not of standard quality”.
The company, meanwhile, along with its director Naresh Goel and technical director MK Sharma, is facing trial in a Sonepat court. A case pertaining to prohibition of manufacture and sale of certain drugs and cosmetics will be heard on October 28. The firm was also blacklisted by the Bihar health department for five years in 2011 after six batches of two drugs were found “substandard”.