India’s top drug regulatory authority has flagged 47 batches of medicines for failing quality tests in December, including Abbott India’s gallstones medication Udiliv 300, Mankind Pharma’s iron supplement Ferikind-M Suspension and Torrent Pharma’s high blood pressure tablets Lorvas SR.
At the same time, Abbott claims the failed sample was a counterfeit of its popular brand, while Torrent claims the regulator failed samples of tablets manufactured as per specifications of one of its export markets.
The Central Drugs Standard Control Organization (CDSCO) this month labelled specific batches of these medicines to be “not of standard quality”.
The regulator has flagged 44 other batches of drugs ranging from eye ointments, painkillers and heartburn medication to antibiotics and critical tablets used in the treatment of hypertension. Over 35 other companies are listed in this alert, including firms like Jackson Laboratories, Aristo Pharmaceuticals, Zim Laboratories, Covalent Laboratories, Zuventus Healthcare, Maxmed Lifesciences, Montek Biopharma, Rajasthan Antibiotics, Hindustan Laboratories and Zee Laboratories.
According to its findings, a batch (010924D7) of Abbott’s Udiliv 300 had failed “identification” tests, which are done to verify the identity of the product. Samples of Ferikind-M suspension failed tests related to “assay” of folic acid—which means there were less quantities of this ingredient than required in the approved dose of the product. The regulator has flagged one batch (A6APS006) of the brand, manufactured by Akums Drugs and Pharmaceuticals, for this reason.
A batch of Torrent’s Lorvas SR (CX23F011) was found substandard for failing “dissolution” tests, which are done to measure how soluble the drug is in the body.
However, the batch of Udiliv mentioned in the alert has been “confirmed” to be a counterfeit batch of medicine and the firm didn’t manufacture it, said an Abbott India spokesperson. A counterfeit is a fake imitation of a genuine product and runs the risk of being ineffective, which means the patients consuming them may not be receiving the therapeutic effects they need to get well. “We alerted authorities and they took necessary action. Abbott takes the quality of its medicines very seriously. Genuine and high-quality Udiliv 300 manufactured by Abbott continues to be available in pharmacies across India,” the spokesperson told The Indian Express. “For the safety and benefit of our patients, we will continue our efforts to alert authorities against counterfeiters,” the person added.
Udiliv 300 is the top grossing brand in the Rs 611.8 crore ursodeoxycholic acid market, accounting for nearly 34 per cent in the 12 months ended December 2019, according to pharmaceutical market research firm AIOCD Awacs Pharmatrac.
Torrent’s spokesperson said that the batch of Lorvas SR failed by the regulator had actually been manufactured for the Russian market, which has different product specifications for the blood pressure drug than the Indian market.
“CDSCO (Baddi Zonal office) had intimated to our manufacturing unit regarding the failure of Lorvas SR tablet on January 2, for which sample was collected by CDSCO DI during WHO-GMP audit in September 2019. Accordingly, we have initiated investigation and found that the said batch was manufactured for Russia market,” a Torrent Pharmaceuticals spokesperson told The Indian Express.
“The manufacturing process and Specification is different for Russia market than the India market and is complying to the Russia specification. Since the batch was manufactured and despatched for Russia market, there is no question of recall from India market,” the person said.
The company has already requested CDSCO to remove its product from the latest alert for this reason and has also suggested that the regulator test the product as per Russian specifications “if needed”.
Lorvas SR accounted for nearly 14 per cent of the Rs 19.7 crore indapamide market as on December, according to Pharmatrac.
Emailed queries to Mankind Pharmaceuticals and Akums Drugs and Pharma about Ferikind-M remained unanswered by press time.
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