Even as the Health Ministry’s ban on 340-odd combination drugs kicked in on Monday, two drug majors Pfizer and Abbott approached the Delhi High Court. The day ended with Pfizer getting an interim stay on the ban of its cough syrup Corex.
A similar petition by Abbott against the ban on its Phensedyl is scheduled to come up tomorrow, an industry source familiar with the development confirmed. Pfizer’s next hearing will come up a week later.
“We have received an interim injunction suspending the operation of the said notification, banning the manufacture for sale and distribution of fixed dose combination of Chlopheniramine Maleate plus Codeine Syrup till the next date of hearing,” Pfizer confirmed.
Corex has a well-established efficacy and safety profile in India for more than 30 years and has both Central and State licences and approvals, it added. Pfizer had said earlier on Monday that it discontinued making and selling Corex, a codeine-based cough syrup, that had clocked ₹176 crore in revenue for the nine-month period ended December 2015.
FDC ban Domestic and foreign drug companies were in a tizzy over the weekend, as the Health Ministry banned 343 fixed doze combination (FDC) drugs on grounds that it posed a risk to humans and alternative drugs were available.
FDC involves combining two or more drugs into one pill or product and it has been under the government’s scanner for a while now. The concern was that companies were taking State level approvals when, in fact, Central approvals were required. And this practice was leading to irrational and unsafe drugs getting into the market.
What upset the industry is that though some 6,200 drugs were being reassessed over a year now, the government’s notification after the expert committee gave its recommendations did not involve follow-up discussions with individual companies, said an industry representative. In fact, the cough syrups had not been discussed, he alleged. Health Ministry officials involved with the notification were not available for comment.
Daara Patel of the Indian Drug Manufacturers’ Association said companies with combination products approved before the government’s 1988 safety cut-off and with the Central authority’s approvals have been banned. This will be challenged by individual drug companies, he said.
The Indian Pharmaceutical Association’s DG Shah said they were not against weeding out irrational combinations, but the process of law needed to be followed. The regulatory regime should be transparent and stable, the IPA said, and not reactionary and knee-jerk.