JOIN USThe government has done well to ban the manufacture, sale and distribution of 328 fixed dose combination (FDC) drugs which have for long been considered a health hazard. The ban has come into immediate effect and covers drug cocktails for treating cold and cough, antibiotics, painkillers, anti-depressants, diabetic drugs, etc., sold under some 6,000 different names. An FDC has two or more active pharmaceutical ingredients combined in a fixed dosage form. FDCs may improve compliance by patients as they need to take only one medicine instead of many, but the drugs have many disadvantages like unnecessary or imbalanced medication and uncertain reactions. Increasing use of antibiotic combinations has also been a matter of concern because it causes antibiotic resistance, which is emerging as a serious threat to heath. The government had banned 349 such drugs in 2016 but the manufacturers challenged the decision in the Supreme Court. The court set up a technical advisory board to examine the claims and counter-claims, and the government’s decision now is based on the board’s recommendations.
The board reported that “there is no therapeutic justification for the ingredients contained in 328 FDCs and these FDCs may involve risk to human beings’’. It also found that many of the FDCs are formulated without due diligence, with the result that dosages in some cases could be toxic. FDCs are cheaper and a single drug can be used to treat multiple illnesses. They are also prescribed when there is confusion about the illness and doctors, especially quacks, are unable to prescribe the right medicine. Pharma companies like FDCs for many reasons. It costs less to manufacture them; the process is also simpler because it is easier to combine two known ingredients than to invent a new drug; they do not come under the price control regime, unlike single ingredient drugs. Together, these factors mean that FDCs yield better profits.
Health activists have been highlighting all the negatives for a long time and warning that the situation was getting very serious. It is estimated that there are about 2,000 FDCs in India while the US has only 500 of them. The drugs which have been banned now account for about Rs 1,000 crore in sales, but the overall market for FDCs is much bigger. The Supreme Court has stayed the ban on three banned FDCs – Saridon, Piriton and Dart, giving conditional permission for their sale. But the court has told the government that it can initiate another investigation into the safety of these drugs. Such investigations should continue, and action should be taken whenever necessary, because the right quality of drugs is very important in the country’s healthcare system.