Government has passed an order banning nearly 350 fixed dose combination (FDC) drugs on safety considerations, but several pharmaceutical companies have got a court stay on the order.

FDC drugs are medications which combine two or more medicines in fixed proportion.

The drugs which came under the Government’s proscribed FDC list included the high-selling Phensydl cough syrup from Abbott India, Corex cough syrup from Pfizer and Vicks Action 500 Extra from Proctor and Gamble (P&G). They had all been previously approved for use.

Other drugs commonly sold over the counter which are on the banned list, include Sinarest, Tripride, Zimnic AZ, Crocin Cold and Flu, D-Cold Total, Nasivion tablets, Kofnil and Dolo Cold.

The interim injunction suspends the operation of the government notification till the next date of hearing.
Abbott India is the Indian arm of the US-based Abbott Healthcare. A company spokesman said it had approached the Delhi High Court for relief as “we were not informed, consulted or allowed a representation by the authority for some important products.” “Some of the other formulations in our petition are in use globally, including the US, UK and Australia, and are approved by regulatory bodies such as the US FDA (Food and Drug Administration),” a company statement said.

On its part, the government said the decision to ban these medicines was taken because they were found to be “irrational” without any therapeutic efficacy and use. Also, in some cases, they were found to be unsafe for mass consumption and as such, there were concerns about their misuse. “We have deliberated on the issue for around four years and these cases were examined and evaluated at different levels by the drug regulator as well as by an expert committee. We also issued show cause notices to companies manufacturing and selling these drugs ,” an official explained.

Health experts say many unapproved formulations and FDCs are sold in India, mostly in the analgesics, anti-depressant and psychotic condition segment.
Meanwhile, the manufacture and sale of Phensydl, Corex and Vicks Action 500 Extra had been suspended by the respective companies.


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