India’s top drug regulatory authority has flagged around 35 batches of medicines, including skin treatment cream brands Betnovate and Panderm, for failing quality tests last month. At the same time, the companies that market these products in India have said that the samples tested were counterfeited versions of their popular brands.
The Central Drugs Standard Control Organisation (CDSCO), earlier this month, labelled specific batches of Betnovate C and Betnovate-N cream as well as Panderm ++ to be “not of standard quality”. According to the regulator’s findings, samples of these products failed tests conducted in October to determine the identity of their ingredients.
It also found a batch of acidity drug brand Lupizole to have failed quality tests.
Weeding out knock-off drugs need of the hour
CDSCO’s latest list highlights the need for a more effective mechanism to weed out knock-offs of popular medicines before they hit the market, given that it is difficult for consumers to ascertain whether a medicine is genuine or fake. Counterfeited products run the risk of being ineffective, which means patients consuming them may not be receiving the therapeutic effects they need to get well.
CDSCO has red-flagged batch number NG980 of Betnovate-C cream for failing these identification tests as well as tests of ‘assay’ of clioquinol, which means there were less quantities of this ingredient than required in the approved combination. It has also found that batch number EZ277 of Betnovate-N failed identification tests. Samples of Panderm ++, belonging to batch number PCF901A, and samples of Lupizole from batch number T9004141 were declared substandard.
“The two batches of Betnovate-N and Betnovate-C that has been included in the quality alert issued by CDSCO are counterfeit batches which were seized by Delhi Drug Control,” said a spokesperson for GlaxoSmithKline Pharmaceuticals Ltd, which markets the products here.
“Both batches have been substantiated as counterfeit by the company and also by the drug control authorities by testing at the government laboratory as well as retesting at GSK sites. The regulatory authority is investigating this matter and will take action as appropriate,” the person said. GSK is engaging with regulators and providing “all requested support” on the matter, the spokesperson added.
Macleods, which markets Panderm ++, has already filed a complaint with the drug regulator and Delhi Police over counterfeits of its skin cream.
According to a spokesperson for the company, the batch number listed by CDSCO is not a Macleods batch number.
“Rather, the said batch number does not adhere to or matches with the batch coding practices of Macleods facility at Sikkim from where the product is impugned to be manufactured plus the details mentioned on the label are actually incorrect and hence the product is a counterfeit,” the spokesperson told The Indian Express.
“Moreover, we had filed a complaint with the FDA and the Delhi Police in the month of August and September, respectively, and an FIR is already registered for the impugned counterfeit Panderm ++,” the spokesperson added.
“The police had seized a huge cache of spurious Panderm ++ but the amount of spurious drug already supplied in the market is unknown and will be known when the investigation is completed. When the FDA, Delhi had approached us to check and confirm the validity of the seized samples, we had after a quick analysis, promptly notified them that the seized samples are counterfeit,” the spokesperson further said.
Emailed queries to Lupin Ltd, which markets Lupizole in India, remained unanswered by press time Saturday.
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.
According to data from pharmaceutical market research firm AIOCD PharmaTrac, Betnovate-C and Betnovate-C captured 100 per cent and 98.78 per cent of these markets, respectively.
Panderm ++ is also the top brand in its segment, capturing over 40 per cent of the Rs 122.70 crore clobetasol + neomycin + miconazole combination market in October, according to PharmaTrac.
Counterfeit medicines are fake imitations of a genuine product and fall under a category of substandard drugs labelled by the World Health Organisation as SSFFC (substandard/spurious/falsely-labelled/falsified/counterfeit).
Counterfeited products run the risk of being ineffective, which means the patients consuming them may not be receiving the therapeutic effects they need to get well. WHO, in 2017, estimated that one in 10 medical products in low and middle-income countries was either substandard or falsified.