Ban on Fixed Dose Combination drugs in india is a right move by Modi Government of India
Dr.M.A.Aleem M.D.D.M (Neuro)
Emeritus Professor
The Tamilnadu Dr.M.G.R. Medical University
Past President
Tamilnadu Pondycherry Association of Neurologists
Former Vice-Principal
KAPV Govt. Medical College and MGM Govt. Hospital.
Fromer HOD and Professor of Neurology Senior Neurology civil surgeon KAPVGMC and
MGM Govt. Hospital
Trichy 620018
Tamilnadu
India
Phone 9443159940
Government of India has banned 328 fixed dose combinations ( FDC) as it was found that the available FDCs in India are without any therapeutic use. A lot of FDCs sold in India are unapproved, given the lack of coordination between state and central regulators. About 70% of non-steroidal anti-inflammatory drug (NSAID) combinations, which are used as painkillers, were being marketed in India without central government approval. There were also concerns about developing resistance against FDCs and decrease in physical immunity in the long run.These drugs have dangerous side-effects and that many of these combinations do not have any advantage over the individual drugs.
They pose a risk to humans and there are safer alternatives available in the market. The combination is not approved for sale in major pharmaceutical markets anywhere in the world
So ban of these FDC drugs in India Is a right move by the Government of India.
Myself and each and every doctor in India welcom this move .It will help to bring healthy future generations .
Sometimes, two or more drugs are combined in a fixed ratio into a single dosage form, which is termed as fixed dose combinations (FDCs). The FDCs are justified when they demonstrate clear benefits in terms of (a) potentiating the therapeutic efficacy, (b) reducing the incidence of adverse effect of drugs, (c) having pharmacokinetic advantage, (d) better compliance by reducing the pill burden, (e) reducing dose of individual drugs, (f) decreasing development of resistance, and (g) cheaper than individual drug because of reduced cost from packaging to distribution. It is important that the above claims are adequately supported by scientific evidence.
The FDCs formulated without due diligence can pose problems namely (a) pharmacodynamic mismatch between the two components, one drug having additive/antagonistic effect leading to reduced efficacy or enhanced toxicity, (b) pharmacokinetic mismatch and having peak efficacy at different time, (c) chemical noncompatibility leading to decreased self life, (d) drug interactions because of the common metabolizing pathways, and (e) limitations of finer dosing titration of individual ingredients.
Although FDCs are available in almost all therapeutic categories, many of them are bizarre combinations. The therapeutic categories having high number of FDCs are cough, cold, and fever preparations; analgesics and muscle relaxants; antimicrobials; drugs for hypertension, dyslipidemia, diabetes, and psychiatric disorders; and vitamins and minerals. The FDC formulation may have up to 5 or even more ingredients with or without rationality of their presence and in the quantity.
On the basis of the rationality of available FDCs in India, we are tempted to classify them as follows: The Good FDCs – having strong justification, for example, carbidopa + levodopa, sulfonamides + trimethoprim, antitubercular drugs, antiretroviral drugs, some antihypertensives, and some antidiabetic medications; the Bad FDCs – are formulated primarily with marketing interests and do not add any value to the therapeutic usefulness and whose justification is debatable. Majority of the available FDCs fall in this category. Some examples are combinations of dual nonsteroidal anti-inflammatory drugs (NSAIDs), NSAIDs with muscle relaxant, and NSAIDs with H2 blockers; and the Ugly FDCs – those that have neither evidence nor theoretical justifications. There could be a possibility of adverse event because of wrongful administration of an unnecessary component, or where the dose titration is required. Some examples of such bizarre combinations are formulations having cough syrups with two or more antihistamines + decongestant + bronchodilator + cough suppressant + expectorant and antifungal + antibiotic + steroid + topical local anesthetic.
In india due to the difficulties in developing new chemical entities, the pharmaceutical industry finds it easier to develop FDCs. India is primarily the market of generic drugs. As the patent expires, the intense competition among multiple manufacturers tempts them to give the product a new look claiming multiple advantages without scientific validation.
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