Over 2,000 fixed dose combinations (FDCs) drugs including some top brands that have not been tested for efficacy and safety standards and have the potential to put patients at health risk are being sold in the market across the country.
This alarming fact has come to the light recently after the Drug Controller General of India (DCGI) cracked the whip nearly two years back on the State drug authorities and drug firms, directing them to give details of the FDCs which were not approved as per its rules.
In the last 18 months till now, it has got as many as 6,000 applications across the country from small and big drug manufacturers and State authorities in this regard, said a senior official from the top drug controller.
Now, in a bid to weed out potentially unsafe combinations, the DCGI has kicked off a drive to evaluate the safety and efficacy of these 2,000 FDCs and plans to weed out those found sub-standard or irrational.
“Assessment of the FDCs is a cumbersome process. But we are going to complete the review soon. We will see that irrational and unsafe drugs are weeded out from the market. Some of these are of no use to the patients but those which are science based and are useful to the consumers will be allowed to be sold,” the official said.
It was in October 2012, the DCGI had ordered State Governments to instruct their drug licensing authorities to not approve manufacturing licenses for companies that have yet to be evaluated by the DCGI. It had also sought report of unapproved FDCs being sold in the market.
The orders followed a report from a Parliamentary panel which found that the high number of unapproved FDCs on the market could be putting patients at risk. The report also blamed the drug controller for being hand in gloves with the pharma companies and giving approval to some drugs without local clinical trials.
Among the list of those unapproved FDCs include antidepressants, muscle relaxant, anti-spasmodics and painkillers which have found their way in the market under licences issued by state drug regulators.
Under the drugs & Cosmetics Act, only the central drug regulator has the remit to grant license to new drugs and combination drugs, for most of which clinical trials have not been conducted fall under the new drugs category.
As per rules, even if the two individual drugs have been approved, their combination will have to undergo clinical trials to get the license to be sold in the market. However, it was found that in many cases, the same drug firm sells the same formulation under different brand names, at different prices, across different parts of the country. It was also found that several of them have no therapeutic justification or rationale to be present in the market place.
Some drug companies are also taking to FDCs to circumvent regulation or bypass drug control, said the official.