Confusion prevails over banned FDC drugs

New Delhi: Serious confusion prevails in the absence of clarity on the High Court interpretation of implementation of ban on some ‘Fixed Dose Combination’ drugs. Senior government officials are reluctant to giving directives to district level authorities and pharmacists unsure of which combination to sell and which to keep off their shelves.

So grave is the confusion that senior officials of the Drug Control Authority are also not too clear on whether stay orders of the Delhi High Court are applicable to the States or not.

The ban is being interpreted by many in accordance with personal choice. It has been observed that some druggists are selling a combination of drugs, while others have totally stopped vending the same.

Consequently, one understands that Pharmacists are confused about which drug combinations to continue selling and which to impose refrain on.

Approximately 300 combination drugs were banned by the Ministry of Health and family Welfare in March this year. These fixed dose combination (FDC) medicines belong to a few pharmaceutical companies.

344 fixed drug combinations were banned by the Ministry through a gazette notification, these included several common cough syrup solutions, analgesics and antibiotic combinations, many of which are sold over the counter.

The lack of clarity in the minds of state officials has led to them not providing any directions at the district level about enforcement of ban or liberal play with regards to the sale of FDC drugs. The officials are now turning their eyes to the High Court in Delhi and waiting for a lucid decision to emerge.

“We have no clarity on the issue and have been following directions of the Delhi High Court, where a legal battle is going on between the union government and the association of manufacturers. We initially enforced ban in the city and now are waiting for a decision from the court,” said B Suresh Babu, Assistant Director, Drug Control Administration.

Metformin 500+Glimperide 2 mg combination drug has increased its price by 30 per cent lately. This has been done against the promise made by the union government to reduce prices of emergency drugs that are for lifelong consumption.

FDC drug prices are being raised by many drug companies. According to a sales boy employed at a medicine counter in Vedayapalem, limited stocks of banned combinations available on his shelf were being asked for by consumers, who were putting pressure on him, for their availability.