Centre's decision last week to ask state drug control authorities to withdraw manufacturing licenses of over 1000 fixed dose combinations is yet an another attempt to fix this serious issue facing drug regulatory system for several years. The decision to withdraw licenses issued to irrational combination drugs was taken at a recent meeting of state drug controllers held in Delhi by the DCGI. Now, if DCGI is serious enough to pursue the matter, thousands of irrational and harmful combination drugs sanctioned by state drug controllers should disappear from the market in a few months from now. Efforts to weed out irrational combinations from the pharmaceutical market were on for a long time. In November 2001, DCGI first issued a directive to state drug controllers prohibiting them not to issue any more licenses for combination drugs. Nothing happened after this and the state drug control departments just ignored this order. Thereafter, DCGI had asked the state drug controllers in July 2004 to withdraw all manufacturing licenses issued by them for drug combinations after May 2002. There has been no follow up action even after this directive.
Medical experts world over have been expressing serious concern over the marketing of increasing number of drug combinations by pharmaceutical companies particularly in the developing countries. The basis for this concern is the fact that a drug combination is technically a new drug entity and its marketing can be allowed only after its safety and efficacy are adequately established. This has to be decided by the DCGI. While combining two drugs, the efficacy and bioavailability of the two drugs undergo a change on account of the reactions between these chemicals. For ailments like TB, patients' intake of more than one drug at a time for longer treatment period is a critical factor and drug combinations are justified for the sake of compliance. But, most of the fixed dose combinations currently marketed in India are not at all rational as their clinical benefits are in doubt. Some of the widely used irrational combinations in the country are ciprofloxacin with tinidazole, amlodipine with lozarten and nifedipine with atenolol. And there are hundreds of combinations nimesulide with a number of other drugs. Many more such drug combinations are getting approved in various parts of the country and are entering into the market on daily basis. Manufacturing licenses of these combinations can be obtained anywhere in India. Most of the state drug controllers do not look into safety aspect of these combinations before they issue licenses. Formation of the proposed Central Drug Authority should put and end to the current system of multiple licensing of drugs and thereby solve the issue of irrational combinations too. But establishment of CDA may take some more time. The fresh initiative by DCGI, in the meanwhile, may set the ball rolling and should be welcomed by all and particularly the industry.