<Burgeoning menace of irrational medicines Dr Chandra M Gulhati Through several gazette notifications on March 10, the Ministry of Health and Family Welfare banned the manufacture and sale of 334* unscientific cocktails of medicines called fixed dose combinations (FDCs). The FDCs are medicines where two or more drugs are combined into one pill, suspension or injection. Since each FDC is sold by many manufacturers under different brand names, thousands of products have been axed. The grounds for the ban, which took immediate effect, includes risk to patients, lack of scientific justification to combine drugs and availability of safer alternatives. Since individual ingredients of banned FDCs are available in plenty, patients can consume them separately if necessary. Thus the interests of consumers are fully protected. It took India over 35 years to realise that irrational FDCs must be weeded out to protect public health. As early as 1981, the Drugs Consultative Committee, a statutory authority comprising the Drugs Controller General of India and state-level drug authorities, had put in place voluntary guidelines as to when medicines can be mixed and when they cannot be combined. In the absence of a law, producers paid no heed and went about launching more and more FDCs to make money. Unlike in western countries, Indian drug manufacturers do not have their own research molecules, they simply copy the western medicines. Over the years, the number of fiercely-competing drug producers has reached an astounding figure of a little over 10,500, the highest in the world! With just about 1,000 basic molecules, producers resorted to introducing more and more FDCs, claiming that each cocktail to be "novel and superior to others" and worthy of prescription. Generally, patients in India are pretty reluctant to undergo diagnostic procedures such as pathological tests, X-ray test, ultrasound etc., due to the cost and consequent delay in starting treatment. For instance, a simple case of diarrhoea can have different causes, like viral, bacterial, fungal or protozoal (such as giardia). The rational approach is to get a stool-test done and then prescribe appropriate medicine. A patient usually prefers a physician in private practice who prescribes drugs without time-consuming tests. Here, pharmaceutical manufacturers offer an instant solution: A cocktail of different drugs that can tackle all possible causes even though most of them are totally unnecessary. The end result is more expenses, more side effects and still worse potential for antibiotic resistance. No wonder "Ofloxacin", once an effective drug for typhoid, is virtually useless today. The regulatory system did not keep pace with the ever-evolving medical science. The lapse was cleverly used by drug manufacturers to make huge profits by bypassing scientific principles. Till 1988, drug combinations of already approved individual agents did not require permission from the Central Drugs Standard Control Organisation (CDSCO). Even when prior approval of CDSCO was made mandatory, state drug authorities continued to issue manufacturing licences for hundreds of irrational FDCs. The result is that even today, there is no authentic, consolidated list of FDCs being sold in the country! The best estimate is that there are additional 500 or more irrational FDCs with thousands of brands in the country that need to be prohibited. Compare this with developed countries, where just over 200 rational FDCs have been approved after intense scrutiny of efficacy and safety. All such rational FDCs are already being marketed in India. In certain disorders such as HIV, tuberculosis and malaria, rational FDCs are invaluable. Therefore, the debate is not on the need for good FDCs but back-door entry of bad and harmful FDCs. In the developed countries, only one out of eight medicines consumed is an FDC, while in India, one out of every two formulations sold is an FDC. This colossal wastage of money is borne by the poor patients without realising that they are being fed with both unnecessary and often harmful combination of drugs just for profits by the pharma industry. Take the example of a cocktail of anti-epileptic drugs phenytoin with phenobarbitone. As per scientific evidence, phenobarbitone decreases the efficacy of phenytoin in most cases thus making the FDC less effective. How can such a combination be marketed? Let us examine another FDC of anti-allergy chlorpheniramine (CPM) with codeine, a painkiller and cough sedative derivative of opium. The "half life" (indicative of duration of action) of CPM is between 12 to 43 hours, while that of codeine is 2.9 hours. Thus dosing schedule of two agents does not match. In addition, side effects of the two ingredients, drowsiness and sedation, get multiplied. Finally, codeine has a huge addiction potential. Cold and cough remedies are considered worthless, except for temporary relief from symptoms, but scientifically, steam inhalation is much better and there is zero expense. A ban from the blue? Industry lobbies are claiming that the decision to ban FDCs was "sudden" and that manufacturers were not "consulted". The claims are false. On scientific issues, manufacturers need not be consulted because all of them have conflict of interest. Producers are hardly expected to suggest prohibition of their own unnecessary or harmful formulations. Drug units need to be consulted only on regulatory issues. In this respect, the health ministry repeatedly advised producers of FDCs, licensed by state drug authorities, to submit evidence of efficacy and safety by giving them an unduly long notice of 18 months. But only 6,200 brands were submitted for scrutiny and the absentee brands which never sought regularisation of their licences need to be detected, reviewed and regulated. An earlier attempt in 2007 to ban just over 200 irrational FDCs was stayed by the Madras High Court. Once the stay is vacated most of these FDCs will need to be banned as well. Even the CDSCO is not above board. It has also cleared irrational FDCs that need to be weeded out. The Parliamentary Committee on Health in its May 2012 report castigated CDSCO for its pro-industry tilt and for having cleared many doubtful FDCs. Monetary loss to producers for existing stocks, who have already made billions in the past on the very irrational FDCs now banned, can be of no consideration because after all drugs are meant to help patients, not hurt them. The present exercise is just the tip of the iceberg. * Ban on some FDCs have been stayed by the Delhi High Court till March 28. However, similar petitions for interim stay on some other FDCs have been rejected by the Madras High Court. The writer is editor, Monthly Index of Medical Specialities (MIMS) div dir="ltr" style="text-align: left;" trbidi="on">
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