Nimesulide

New Delhi: Makers of anti-inflammatory drug nimesulide will be required to display cautionary warning labels that the drug be used only as a second-line treatment for patients 12 years and above after all the first-line options are exhausted. The market for nimesulide formulations in India is about ₹500 crore, expanding at 11% over the past 12 months, as per data from market research firm PharmaTrac. The apex Indian drug regulator-Central Drugs Standard Control Organization-has conveyed the decision to the state level agencies. According to the September 15 circular the box warning should also mention that the drug must not be used in pregnant, lactating and women planning for pregnancy. Also, the label must add that it should not be used in patients with renal and hepatic impairment and should not be co-administered with other hepatotoxic and renal toxic drugs. The government decision comes on the back of a report by the Indian Council of Medical Research, which was tasked by the health ministry to study the impact of nimesulide on adults amid concerns that the drug could cause liver damage in some patients. By Teena Thacker ,

New Delhi: In its routine quality review, India’s drug regulator has flagged 143 batches of Not of Standard Quality (NSQ) drugs along with eight spurious samples. Of the 143 NSQ samples, 46 were identified by the central drug testing laboratories, while the remaining 97 were flagged by state drug laboratories, according to an alert issued by the CDSCO . The eight spurious samples include Venclyxto Tablets , Deca-Durabolin , Thrombophob, Augmentin , PAN 40, Clavam 625, and two Telma H samples. According to a note from the Union Health Ministry, all eight samples identified in July were manufactured by “unauthorized manufacturers using brand names owned by other companies.” The matter is under investigation, and action will be taken as per the Act and Rules. The CDSCO alert further stated, “The actual manufacturer (as per label claim) has confirmed that the impugned batch of the product was not manufactured by them, and that it is a spurious drug.” Notably, some of the flagged spurious samples belong to therapies featuring among the top 30 brands in the country and include products marketed by both multinational and Indian pharmaceutical companies. Meanwhile, the NSQ list includes several widely used medicines such as paracetamol, nimesulide, metformin hydrochloride, calcium supplements, vitamin supplements, and other common drugs. While the Health Ministry issued a note on the monthly alert, the detailed list of drugs, along with responses from their registered manufacturers, was released by the CDSCO a week later. The delay is possibly linked to the launch of a new dedicated portal by the CDSCO, which provides searchable access to all NSQ alerts issued since 2019. However, spurious sample data from the same timeline is yet to be uploaded on the portal. Under Section 17-B of the Drugs and Cosmetics Act, 1940, a drug is deemed spurious if it meets certain conditions specified therein. Identification of NSQ drugs is based on failures in one or more of the specified quality parameters, as defined under Section 16(1)(a) of the same Act. By Online Bureau ,