The government's decision to ban more than 300 irrational fixed dose combinations (FDC) triggered a storm in the Indian pharmaceutical market where such FDCs enjoy a sizable market share. Several firms approached the Delhi High Court seeking to cancel the order that would adversely impact their bottom line. The latest order comes nine years after a similar government attempt, which could not be executed as the order was challenged in the Madras High Court. The jury is still out. Dr Gopal Dabade Modern allopathic medicines are powerful but only when used rationally and judiciously. Pharmacology, the medical science subject that deals with the proper and scientific use of medicines, has evolved over decades and outlines how these powerful remedies should be used. If used injudiciously or irrationally, the same medicine can prove harmful. In fact, medicine is a powerful double-edged sword. It is precisely this disregard for modern medical science that has opened the Pandora's box leading to the flooding of irrational drugs into the Indian market. The news banning 344 irrational drug combinations on March 14 hit the headlines of most Indian newspapers and channels. This ban affects 1,600 brands worth Rs 3,700 crore. The media's favourite question is how were these drugs allowed and how is it that we have been using them for several years now. Before we answer these questions, we first need to know what are FDCs (fixed dose combinations), as all the drugs banned by the Drug Controller General of India (DCGI) are FDCs. When two or more drugs are combined they are then referred to as FDCs. Medical science has more to add to this. When such combinations are made the drug that has emerged as a combination is totally a "new" drug by itself. It is this simple and profound law of modern medical science that has been totally dishonoured both by drug companies and regulatory authorities, and this has led to the huge number of irrational drugs in the market. It is most obvious that both the regulatory authorities and drug companies have joined hands for these dubious activities. Now, how did these drugs get such a huge market? As the drug companies got the clearance (of course by using nefarious methods), the next step was to promote and advertise the drug using all modern marketing techniques and push the drug into the market. The "drug marketing wing" of the drug companies uses the old-age technique, "keep telling the same lie over and over again in a loud and clear fashion till the lie appears to be the truth". And the drug companies have proved often that they are very good at this. Take an example, modern medicine acknowledges that there is no cure for common cold. "Common cold lasts for just seven days if treatment is taken, otherwise it lasts for one week", goes a popular medical proverb. But drug companies sell medicines worth crores of rupees to treat it and claim that it can even be cured! The common cough-cold remedies that flood the Indian market are a combination of expectorant and suppressant, which in simple terms means that the phlegm in the respiratory tract either has to be removed by using an expectorant, and that if there is not much phlegm (only an irritating cough), the same needs to be suppressed. But our Indian drug industry makes a combination of both of them! This must be unique to India. Such a combination only confuses the body further and may even worsen the condition of patient. It is interesting to note that Codeine is a drug that is recommended for use as cough suppressant, as per medical science. This drug was used extensively to treat the irritating cough of tuberculosis when antibiotics were not available. With the advent of powerful antibiotics, the use of Codeine to treat the cough associated with tuberculosis declined but the same continued to be used for irritating cough of common cold. But Codeine is a drug of addiction and this action is potentiated when combined with other anti-allergy medicines. The so-called cough syrups have also been abused by drug-addicts, especially among college-going youths, to get a "kick". The drug companies even smuggled truck loads of these cough syrups across the border into Bangladesh, where alcohol is not permitted. So literally, drug companies became "drug peddlers". The huge promotion and sales of these irrational FDCs have even edged out Essential Medicines out of the market! For example, there are hardly any rational medicines to treat anaemia-an extremely common condition, more so in pregnant women-in the dominant private healthcare industry, while irrational FDCs to treat anaemia flood the market. There are many such instances. An expert committee headed by Dr Chandrakant Kokate, vice-chancellor of KLE University, Belagavi, has examined in detail the issue and used references from modern medical literature to check if there can be some justification in these FDCs. The panel's report can be accessed on Central Drugs Standard Control Organisation website. It is needless to mention that these FDCs do not find mention in any standard textbooks of medicines or even journals. The World Health Organisation (WHO) recognises that irrational FDCs are a great public health problem, because scant resources on health end up being used on useless and irrational medicines and this is sheer economic waste. The World Bank notes that 85% of the out-of-pocket expenditure is on private healthcare. Way back in 1975, the Hathi Committee, headed by MP Jaisukhlal Hathi, had advocated a simple but revolutionary way. It had suggested that all drugs should be manufactured by generic name only and that brand names should be weeded out in a phased manner. Unfortunately, the recommendations met the dust bin, but Bangladesh studied this report and issued the Bangladesh Drug Ordinance 1982, which saw several thousands of irrational medicines out of the market. But this gain was stifled by the powerful drug lobby. The way forward The drug companies have approached the court seeking a stay on the ban issued by the DCGI. The drug companies seem to have professionalised the art of legitimising FDCs. The drug controller may try to urge the courts that a stay should not be granted. But the drug companies have mastered the art of overcoming the ban. How do the companies do it? Very simple! Let us say when the government issues a ban for a combination of Vitamin B1+B6+B12, the drug companies just add another Vitamin B2 (Riboflavin) to this and overcome the ban. So instead of banning each and every single FDC (which in any case is impossible) the government should come out with a list of FDCs that are scientific. It should be noted that, all FDCs are not bad. WHO has a list of essential drugs (19th WHO Essential Model List of Essential Medicines, April 2015). This list which is revised every three years has totally 425 drugs of which 27 are scientifically approved FDCs. Few examples are the popular ORS (Oral Rehydration Solution) or Iron + Folic acid (for anaemia). The drug regulatory authorities should insist that only these FDCs are to be manufactured and nothing else. If not even this big exercise of banning of 344 irrational FDCs, and in spite of the huge media attention, will just be another mockery. The writer is the Karnataka convenor of All India Drug Action Network (AIDAN) What is fixed dose combination? n DCs are combination of two or more active molecules in a fixed ratio of doses. n They are important in public health and are particularly useful in the management of HIV/AIDS, malaria and TB n The WHO essential list of medicine (the 19th edition published in April 2015) has 27 FDCs, whereas the National List of Essential Medicine of India (2011) contain 14 FDCs. n But hundreds of irrational FDCs are being marketed in India under thousands of brand names. n The FDC market is estimated to be around Rs 40,000-50,000 crore, including rational and irrational FDCs Demerits of FDCs n Dosage alteration of one drug is not possible without alteration of other drug n Differing pharmacokinetics of constituent drugs n Increased chances of adverse drug effects n One of the drugs in combination may be superfluous or wasteful, ex: vitamins+iron n Higher prices by adding unnecessary drugs When are they useful n Medical rationale for the combination n Identifiable patient group that benefits n Combination has greater efficacy n The incidence of adverse reactions with the combination is lower n For antimicrobials, the combination results in reduced incidence of resistance n One drug acts as a booster n Therapy is simplified n An ingredient is intended to minimise abuse of other component n Better patient adherence n Lower cost Country FDC Single drugs India 49.6% 50.3% Brazil 33.1% 66.9% Russia 23.4% 76.6% German 16.7% 83.3% France 14.7% 85.3% China 14.4% 85.6% USA 13.9% 86.1% UK 13.9% 86.1% Japan 10.5% 89.5% (Source: IMS Health MIDAS; Total may not add up to 100% due to rounding off) Rules for manufacture and sale n After amendment of the Drugs Act in 1982, the government acquired the power to prohibit manufacture and sale of certain drugs and irrational FDCs. n A gazette notification was issued in July 1983 banning several drugs and their FDCs. Since then, the Drugs Controller General of India (DCGI) was notifying the list of banned drugs on a regular basis. n Ideally, before marketing FDCs, the cumulative toxicities and risks-benefits need to be clinically and pharmacologically evaluated. But this exercise is rarely done. n The first genuine attempt to weed out irrational and harmful combinations of drugs marketed in India was initiated by DCGI in 2007 when it directed the state drug controllers to withdraw 294 FDCs from the market. n The order could not be enforced. Associations challenged it in Madras HC resulting in interim stay. The case is still not settled. n The Parliamentary Standing Committee on Health red-flagged the menace in its 59th report tabled in 2012 n In January 2013, DCGI issued a fresh directive to manufacturers asking them to prove the safety and efficacy of FDC approved before October 2012, and all those FDCs approved by the states without the DCGI approval. n If not compliant, these FDCs were to be considered for ban. However, licences for new FDCs continued to be issued by the state
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