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Times Of India
04 July 2013
Mumbai, India.
Asks Pharma Cos To Prove Safety & Efficacy Of Fixed Dose Combinations By August 30

The government has finally got cracking on regulating harmful and irrational combination medicines in the market, directing pharma manufacturers to prove their safety and efficacy claims. This comes close on the heels of a recent move banning three widely used medicines, including diabetes drug pioglitazone.

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Such combination medicines, also called fixed dose combinations (FDCs), are popular across several therapeutic areas like painkillers, antibiotics, cough remedies and anti–depressants. It is believed that a sizeable number of these combination drugs are of doubtful rationality and may not be of any use to patients, while certain FDCs have not been clinically tested for safety and efficacy, and hence may be harmful.

The government has asked companies which have manufacturing licences for these combination medicines from state regulatory authorities to prove their safety and efficacy claims by submitting documents by August 30, according to a notification issued by the directorate general of health services. These drugs were licensed by state regulatory authorities before October 2012, and subsequently given 18 months to prove their safety and efficacy before the drugs controller general of India (DCGI). But till now, hardly any company has done so, it adds.

An FDC is a drug created by combining two or more existing drugs, and has to be approved by the drugs controller after the procedure of clinical trials and documentation has been completed. In this case, though the manufacturer has got approval from state regulatory authorities, the drug has not gone through clinical testing and needs to go through trials before obtaining approval of the drugs controller.

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Recently a parliamentary committee on health had rapped the government on drugs approved without clinical trials and harmful fixed dose combinations, questioning why even after several months these drugs continue to be marketed with impunity.

In an earlier crackdown against irrational combination medicines in 2007 when the states were asked to withdraw 294 FDCs which were licensed without DCGI approval, the industry got a stay order from the Madras high court. The matter is still sub judice, and a decision on these 294 FDCs will be taken after the outcome of the case, the notification says.

It is estimated that of the 1,700 top selling brands in the market, about 44% are fixeddose combinations.

"When you combine two drugs for the first time, then under Indian law it becomes a new product. Because drug A is separate and drug B is separate, A+B is not AB, it makes C. Which means C is totally different from A+B and they have nothing in common," says Dr CM Gulhati, editor of medical journal, MIMS. Also, there is a long–held belief that certain combinations are irrational — meaning one of the drugs used to make the new product may not necessarily cure the ailment it is meant for but may actually harm the patient.

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