Lately, India’s leading drug authority flagged almost 35 batches of medicines, including popular skin medication cream brands Betnovate and Panderm as they failed quality tests conducted last month. At the same time, companies that market these products in India said that the samples tested by the regulator were fake versions of their famous brands
Earlier this month, the Central Drugs Standard Organisation had marked specific batches of Betnovate C, Betnovate N & Panderm ++ failing in quality standards. According to the authority, the samples failed in tests conducted to determine their ingredients. The regulator also found that a batch of acidity drug Lupizole also failed in the tests.
While conducting the tests, CDSCO had identified batch number NG980 of Betnovate C cream for failing in identification tests along with tests of ‘assay’ of clioquinol- which means that the cream had fewer quantities of this ingredient. The batch number of EZ277 of Betnovate-N also failed in the identification test, whereas samples of Panderm ++ batch number PCF901A and Lupizole batch number T9004141 were declared substandard by the authority.
While commenting on the issue a spokesperson from GlaxoSmithKline which markets the product in India said that the two batches of Betnovate-N and Betnovate-C seized by Delhi Drug Control are counterfeits. He further added that the two batches were marked counterfeit by the company and the authority, after testing them at government labs and retesting at GSK sites. Meanwhile, GSK is coordinating with the regulator and providing its full support in the matter.
Macleods, which markets Panderm ++, has already filed a complaint with the drug regulator and Delhi Police over counterfeits of its skin treatment cream. A representative from the company said that the batch number listed by CDSCO is not correct and does not abide by the coding practices of Macleods Sikkim facility. Moreover, the details mentioned on the label are inaccurate which identifies the product as a counterfeit. Macleods had filed a complaint with the FDA and the Delhi Police in the month of August and September while an FIR has already been registered for the impugned counterfeit Panderm ++. Emailed queries to Lupin Ltd, which markets Lupizole in India, remained unanswered by press time Saturday.
Some quick facts:
- In October 2019, Betnovate-C was the largest brand in the over Rs 210 crore betamethasone + clioquinol combination market, while Betnovate-N was the largest in the nearly Rs 195 crore betamethasone + neomycin combination market.
- In October 2019, Betnovate-C was the largest brand in the over Rs 210 crore betamethasone + clioquinol combination market.
- In October 2019, Betnovate-N was the largest in the nearly Rs 195 crore betamethasone + neomycin combination market.
- According to AIOCD and PharmaTrac, Betnovate-C and Betnovate-C captured 100 percent and 98.78 percent of these markets.
- Panderm ++ is also the top brand in its segment, capturing over 40 percent of the Rs 122.70 crore clobetasol + neomycin + miconazole combination market in October.