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Generic drugs

Generic drugs

It is being stated by well meaning persons that doctors should write generic drugs to hold down the high cost of medicines and  to make them affordable. That sounds reasonable. ‘MCI regulation proposed is to be read as: “Every physician should prescribe drugs with generic names legibly and preferably in capital letters and he/she shall ensure that there is a rational prescription and use of drugs.” This regulation, as of now, urges doctors to prescribe generic drugs “as far as possible”.

What is a generic drug?

A generic drug is a pharmaceutical drug that is equivalent to a brand-name product in dosage, strength, route of administration, quality, performance, and intended use. The term may also refer to any drug marketed under its chemical name without advertising, or to the chemical makeup of a drug rather than the brand name under which the drug is sold.  The cost of a branded drug includes discovering, testing, and obtaining regulatory approval for a new drug, with a new chemical entity, is much higher. For as long as a drug patent lasts, company enjoys a period of market exclusivity, or monopoly, in which the company is able to set the price of the drug at a level that maximizes profit. This profit often greatly exceeds the development and production costs of the drug, allowing the company to offset the cost of research and development of other drugs that are not profitable. Generic drugs are usually sold for significantly lower prices than their branded equivalents and at lower profit margins. One reason for this is that competition increases among producers when a drug is no longer protected by patents.  Companies incur fewer costs in creating generic drugs—only the cost of manufacturing, without the costs of drug discovery and drug development—and are therefore able to maintain profitability at a lower price However, affordable healthcare is still a distant reality for thousands of Indians who aren’t even aware that a generic substitute is available for the expensive medicine they have been prescribed. Ignorance of the patient, coupled with greed of the corporate entities and their agents and unethical practices by some medical practitioners is making the medicines far more unaffordable. Leaving aside the branded medicines, even generics are labeled as 10-20 times of the actual cost and the patient is at the mercy of the chemist, how much to be charged? This loot must be eliminated.

Why should physicians prescribe more expensive brand-name drugs when equally effective, well-proven and less-expensive generic versions are available? Even the differences in the cost of medicines being sold by one good medicine house say Glaxo may differ as much as 5-10 times from another, say FDC. Why? The quality issue is not the reason here-since both are equally good. The American College of Physicians asserts that generic drugs are just as effective as their brand name equivalents. However several doctors don’t agree. They claim a loss of effect or adverse effects among patients who had switched from the brand-name to the generic version of this agent.  They add that generic versions of drugs were found not to be bioequivalent to the brand-name version. If that is correct there is a place for Branded medicines, at least for the rich. We are not sure that the pharmaceutical company producing that generic drug is applying equal measures of quality control that it applies with its branded drugs. It’s not only the amount of a particular compound in a tablet or capsule that matters but other chemicals which help the compound to reach to the tissues at a particular rate are also significantly important, said one senior doctor’ European Union suspended the sale of 700 generic drug formulations from India. The reason was that the company responsible for testing the generic drugs in subjects in India violated standard procedures. Equally disturbing is a Reuters report noting that the FDA has barred 44 manufacturing plants in India from exporting their medications to the U.S. since 2011. Some of the companies involved include Aurobindo, Polydrug, Ranbaxy, Sun Pharmaceutical and Wockhardt. Last summer the FDA required Dr. Reddy’s Laboratories to recall certain lots of the anti-seizure drug divalproex, the blood pressure pill amlodipine and the cholesterol-lowering medicine atorvastatin.  FDA  observed ‘Several violations are recurrent or represent long-standing failures to adequately resolve significant manufacturing quality problems. It is apparent that you have not implemented a robust quality system at Indian generic drugs units:

Will FDI help to improve quality and affordability?

There has been a lot of talk about FDI in generic drugs manufacturing in India. Will it expose the Indian patients to the vagaries of excessive profits of foreign agents? India needs a domestic pharmaceutical industry that is unfettered by foreign dominion and control, particularly by a rapacious multinational industry that so consistently prioritizes supra profits for its executives. With increased clout in the domestic pharmaceutical industry and in pursuit of its own self-interest in the Indian and export markets, foreign controlled pharmaceuticals can be expected to pursue policies undermining India’s commitment to the full use of public health safeguards in its patent law that encourage competition to lower medicine prices .

Generic drugs would account for 85 per cent share in the domestic pharma market by 2020, fuelled by cheap labor, patent cliff of blockbuster drugs and prevalence of lifestyle diseases, according to a study on ‘Generic Medicines in India – Promulgating Growth & Access.’ The domestic generic drug market is expected to cross $27.9 billion from the current level of $13.1 billion registering compound annual growth rate (CAGR) of about 16.3 per cent particularly due to approval accorded by USFDA makers and 21 drugs patent losing patent by 2019.

 

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