Generic drugs are an important piece of India’s healthcare puzzle but they are not the solution to all ills. The government’s decision to make compulsory prescription of generic drugs is a shortsighted one
Prime Minister Narendra Modi set the cat among the pigeons when he announced that his government is planning to bring a legal framework into place under which doctors will have to prescribe drugs by their generic names. In other words, instead of writing down a prescription for Crocin, a doctor would simply write down paracetamol 500 mg. While the union government is claiming that this is a brainwave that came straight from PM Modi, the truth is that this is not a new intervention. The Medical Council of India(MCI) had already notified an amendment in the Indian Medical Council Regulations, 2002. The amended clause now reads:” Every physician should prescribe drugs with generic names and he/she shall ensure that there are rational prescription and use of drugs”.
For the uninitiated, a generic drug is identical or bioequivalent to a brand name in dosage, strength, performance characteristics and intended use. Any generic drug modeled after a single, brand name drug must perform approximately the same in the body as the brand-name drug. There will always be a slight, but not medically important, level of natural variability – just as there is for one batch of brand name drug compared to the next batch of brand name product. Generic drugs don’t need the excruciatingly drawn-out safety and efficacy studies required for new brand-name medications, but they do need to pass a bioequivalence study proving that their drug is absorbed the same way as the original. Although generic drugs are chemically identical to their branded counterparts, they are typically sold at substantial discounts from the branded price.
This is also perhaps the reason why they have for long been loathed by Big Pharma. When a pharmaceutical company develops a new drug often after years of painstaking research and clinical trials, it applies for a patent that marks the new drug as the company's exclusive intellectual property for a fixed period of time. Patents, in effect, are temporary monopolies. Most pharma companies exploit this period of no-competition by hiking up the price of the drug manifold and making monopoly profits. During this time, they can and do price-gouge as much as they want. The most prominent and egregious case of this sort of price gouging was when Turing pharmaceuticals brought the right for Daraprim and hiked its price from 13 dollars to an outrageous 750 dollars. Daraprim is a medication used for AIDS and cancer patients to fight life-threatening parasitic infections like toxoplasmosis. Turing is a classic example of what happens when healthcare is left completely in the hands of predatory market forces.
This begs the question: why aren’t generic drugs more popular? Perhaps the biggest reason for this emanates from a conflict of interest. Most doctors in private hospitals recommend branded drugs because pharma representatives are eager to line the doctor’s pockets for recommending their particular brand. The reason this practice thrives is because a large number of patients in the country are illiterate and even many literate patients are not well-versed with medical terms and drug composition. Doctors normally prescribe higher-priced drugs in the belief, held genuinely or owing to persuasion from pharmaceutical companies, that costlier brands are better even if a cheaper brand is available from the same company.
At the end of the day second-guessing a doctor's motives is rarely in the best interest of a patient. On top of this generic drugs have a perception problem. Like the Tata Nano which was perceived as an inferior car simply because of its price tag, a generic drug suffers from a perception of being of inferior quality simply because it is cheap. The price difference between an Aceclofenac + Paracetamol (100 mg + 325mg) Tab dispensed at a Jan Aushadhi as opposed to a branded generic drug is substantial. Their effects on the patient though are entirely identical. Coupled with the fact that retail pharmacies are generally unenthusiastic about stocking drugs with low-profit margins makes the challenges faced by generic drugs even worse. Given the fact that there are only 10,000 odd Jan Aushadhis access to generic drugs remains a problem.
Then there is the problem of rational prescription. According to WHO, rational use of medicines requires that "patients receive medications appropriate to their clinical needs, in doses that meet their own individual requirements, for an adequate period of time, and at the lowest cost to them and their community.” Perhaps in an effort to mimic this stated tenet of healthcare, the MCI announced that it was the duty of doctors to prescribe a rational use of medicines. The move fell flat on its face because a significant part of drug sales are irrational fixed dose combinations(FDCs). Most doctors adopt a more the merrier drug approach, trying to cover all possibilities. Very brieﬂy, an FDC, which is a combination of two or more drugs, is acceptable when it has decided advantages such as ensuring better compliance of the patient, or there is an added clinical advantage, or synergy, with two or more drugs. FDCs have been found very useful in tuberculosis, malaria, HIV/AIDS. But in most other cases FDCs are harmful. These include FDCs of painkillers, antibiotics,antidiabetics that make routine treatment ineffective or complicated and/or more costly. Irrational FDCs of antibiotics are among the major causes of antibiotic resistance in India.
About 40 percent of the estimated 60,000 drug formulations sold in India are fixed dose combinations, of multiple pharmacological ingredients which are only sold through brand names. India’s 1,00,000 crore drug market is dominated by branded drugs. Nearly 90 percent of all drugs sold are branded ones. Then there is the cold, hard reality that there simply are not enough generic name equivalents of branded medicines sold. About half the market—₹50,000 crore and more—is for fixed-dose combinations (FDCs) of drugs. Many FDC drugs contain even eight or nine medicines. To write and remember the constituents of thousands of generic drugs is practically impossible. Even in such an impossible scenario, pharmacists would resort to stocking combinations that yield them better profits.
For this move to materialise into anything resembling reality , the generic medicine industry will also have to pull up its socks. Last year, 27 commonly-used medicines in the country failed quality tests. The drugs were found wanting on several counts, including false labeling and inadequate quantity of ingredients. Ensuring quality of drugs is a problem in the absence of adequate regulations and a shortage of drug inspectors and lab facilities to check drug quality. The number of drug inspectors — approximately 1,500 now — must be increased. The government must also look to enforce price control on an enlarged list of essential drugs. The current market-based approach for the Drug Price Control Order (DPCO) 2013 is a sham with margins reaching 10,000 percent sometimes. Despite the government's and pharmaceutical lobby's claims and counterclaims, the Drugs (Prices Control) Order, 2013, which covers only 18 percent of the total domestic market, has had very little positive effect as a price control policy. Drug price control is the real issue. Not compulsory prescribing of generic drugs.