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Indian govt set to ban 1,200 fixed-dose combination drugs, reports

pharmafile | March 18, 2016 | News story | Business Services, Medical Communications, Sales and Marketing Abbott Laboratories, Pfizer, cough drug, pharma 

Indian regulators are set to ban an additional 1,200 fixed-dose combinations, sent for probe by Drug Controller General of India (DGCI), according to media reports.

The Indian Health Ministry, earlier this week, announced a ban on more than 350 fixed-dose combinations (FDCs) in the country for safety reasons. The ban included cough syrups produced by the local arms of pharma giant Pfizer (NYSE: PFE) and Abbott Laboratories (NYSE: ABT), sending the shares in the companies lower on the Bombay Stock Exchange.

Fixed dose combination or FDC drugs contain two or more active pharmaceutical ingredients in fixed proportions in a single pill and also contain codeine which causes lethal damage to brain and psyche.

According to reports, so far about 6,600 FDCs have been reviewed​ by a committee and have been classified under four categories of irrational, require further deliberations, rational and require additional data generation.

The DCGI will come up with the new list of banned drugs in six months after the panel reviews the drugs classified in the “require further deliberations” category.

The health ministry said the FDCs that have been banned were found to cause anti-microbial resistance (AMR), and increase the toxicity level in the body of patients, which could lead to organ failure.

Anjali Shukla

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