Pharma distributors stuck with banned FDC drugs

The Centre banned 344 FDC drugs based on the findings of an expert panel

April 25, 2016 12:00 am | Updated September 09, 2016 12:07 am IST

The Centre’s recent ban on Fixed-Dose Combination (FDC) drugs has put pharmaceutical distributors and some medical shops here in a quandary. Drug manufacturers, who were supposed to take back the FDC stock, are not doing so citing stay orders which they have got from courts in other States, and the medicines which cannot be sold are lying in storage.

And even though some of the manufacturers have gotten stay orders, the State government also issued a circular on its own banning the sale of the FDC drugs in Telangana, said officials from the Drug Control Administration (DCA). “The ban is intact in the State, as no one has challenged that itself here. Also, we have not received any notice as of now from courts staying the ban,” said Akun Sabharwal, director, DCA.

And this peculiar situation has put medical shops and pharmaceutical distributors at unease in Hyderabad. Some of them said that they are stuck, as they cannot sell the FDC medicines, and nor can they return it. “The manufacturing companies are not taking back the stock, and we have no other option but to wait. Earlier we thought that everything will be taken back. There are over 2000 types of FDC drugs,” said a medical shop owner in the city, unwilling to be identified.

DCA officials said that while some States are allowing the sale of FDC drugs after court stay order, the sale of the FDC drugs is not justified. “The ban is in place for public safety, as no one has come forward to prove that these drugs are safer to use. Most of the objections from companies are on other counts. Till someone challenges the State government’s notification the ban will be in effect in Telangana,” said a senior official.

The Centre had banned 344 FDC drugs on March 10 based on the findings of an expert panel that these medicines lacked therapeutic benefit and posed health risk to patients. Post that, the DCA here had given medical stores a window of 30 days to return their FDC stock, and stop sale immediately.

‘Till someone challenges the State notification, the ban will be in effect’

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