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Two more drug companies, Abbott and Macleods, have got an interim stay from the Delhi High Court against the ban on their respective combination products.
The development comes on the heels of a similar stay that Pfizer got from the same court on Monday, after the Union Health Ministry banned over 340 fixed doze combination drugs (FDC), including Pfizer cough syrup Corex and Abbott’s Phensedyl.
Confirming the development, Abbott said it received an interim injunction for five products, which include codeine-based formulations and a formulation indicated for management of epilepsy. These formulations have been in use in India and globally over decades and are the treatment of choice in specific medical conditions, the company said.
On Phensedyl, it added, the product had received approval from the Drug Controller General of India in 1995 and had been on the market in India since the 1980s, where it has been used safely and effectively by physicians and patients. “Some of the other formulations in our petition are in use globally, including the US, the UK and Australia and are approved by regulatory bodies such as the US FDA (Food and Drug Administration) and have been the treatment of choice in specific medical conditions,” it added.
Pratibha Singh, the counsel for Macleods told BusinessLine that the company’s product, an antifungal ointment, had been in the market for several years.
On its part, the Government counsel said that the action had been taken after consultation, and review by an expert committee and because they believed the combination products did not have any therapeutic value.
The next hearing of these cases comes up next week. Meanwhile, a bunch of other companies, including Glenmark, for instance, are also taking legal recourse, a company official confirmed.
According to AIOCD-AWACS, the market research company of All India Chemists and Druggists Association (AIOCD), the FDC ban’s impact on the ₹98,042-crore Indian pharmaceutical market was pegged at ₹3,049 crore, or 3.1 percent of the market.
The available unsold stocks with the manufacturers and distributors in the market is valued at approximately ₹7,000 crore, the AIOCD said, adding that it would be a logistic nightmare to take back banned stocks and send to the companies with immediate effect.
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