In its latest guidelines, the National Medical Commission (NMC), a regulatory body stated that as generic medicines are 30 to 80 per cent cheaper than branded drugs, prescribing generic medicines may overtly bring down healthcare costs and improve access to quality care.
The NMC defines generic drugs as “drug product that is comparable to brand/reference listed product in dosage form, strength, route of administration, quality and performance characteristics, and intended use.”
On August 2, the NMC imposed a directive mandating doctors to prescribe generic drugs instead of branded equivalents. This means that when a patient approaches a doctor for say fever, he/she can now simply write paracetamol instead of mentioning the brand name of the drug Dolo 650, which is generally consumed in India in cases of fever. Failing to do so could get the doctor penalised, as per the directive.
“Every RMP (registered medical practitioner) should prescribe drugs using generic names written legibly and prescribe drugs rationally, avoiding unnecessary medications and irrational fixed-dose combination tablets,” the regulation stated under ‘Regulations relating to Professional Conduct of Registered Medical Practitioners.’
But in the last fortnight, numerous doctors, especially those practicing as family physicians, have protested the directive and are trying to get the Union health minister to intervene and rescind the rule.
The Indian Medical Association (IMA) too, issued a statement strongly opposing the regulation. “The notification is an injustice to doctors who always hold the interest of their patients as non-negotiable. If the government and NMC want all the doctors in the country to prescribe only generic drugs, they should simply order all pharmaceutical companies to manufacture all the drugs without brand names. Then no one has to write the brand name. Let the NMC/GOI ensure quality generic drugs or accept responsibility if patients fail to respond to prescribed generics,” the association said in a statement.
The point of contention here is that by prescribing generic drugs and not naming the brands, the doctors help in letting the patient decide which brand to go with and the cost of the drug comes down considerably. Many drugs are priced high because of the brand name associated with them. For instance, paracetamol is developed by a number of different companies and Dolo is not the only brand out there. But because doctors prescribe Dolo and not Paracetamol, patients end up buying the Dolo brand and pay the price quoted by it, even when the same paracetamol, developed by other companies might be available at a cheaper price. So, essentially, generic medicine is the same drug minus the brand.
According to the United States Food and Drug Administration (USFDA), generic medicines work in the same way and provide the same clinical benefit and risks as their brand-name counterparts. Branded drugs are those which are launched by a pharmaceutical company with a specific name and patent protection often to treat challenging medical conditions. However, after a certain period of time when the patent expires, generic medicines can be launched for these branded drugs.
Then why are doctors protesting against prescribing generic drugs? Dr Ramesh Shah, a family physician practicing in Mumbai, said, "The decision to prescribe medicines of any brand is the right of the doctors. We know our patients best and understand their requirements. Branded drugs also come with credibility and a set of norms and practices all of which go a long way in establishing trust with the drugs they make. Hence, this universally binding rule that we must only prescribe generics is not fair at all."
Another practicing physician at Nulife hospital in Mumbai's Ghatkopar, Dr Deepak Baid questions the regulation saying that the rule "directly questions the ethics of a medical practitioner."
"The NMC is indirectly making an allegation that doctors are prescribing brands out of some motive which is not right. Every doctor has a right to prescribe whichever medicine they want. Also, it is practically difficult for a doctor to write the generics in all cases. So if there is a cough syrup or a vitamin supplement like B-complex to be prescribed, it becomes challenging to write down the generic compositions because there are so many. In fact, the best thing would be for the government to ban the brands altogether across the country so that doctors are forced to only prescribe generics," says Dr Baid, former president of AMC (association of medical consultants).
Pharmaceutical companies hold international patent rights which give them the exclusive right to produce a new drug for a specific period, which may run into decades after its development. It is only after the lapse of the patent that generic formulations are allowed into the market according to the current drug production laws.
Generic drugs have an important place in healthcare because they are less expensive and mimic the original drug in terms of the active ingredients, dose, dosage form, and bioequivalence. They are copies of the original drugs that have exactly the same intended use, effects and side effects, route of administration, risks, safety, and strength as the original drug.
Physicians often refer to original drugs by their brand names, resulting in these drugs being widely prescribed even when less expensive bioequivalent generic alternatives are available. According to the WHO, having Standard Treatment Guidelines and Essential drug lists (which includes generic drugs) could promote rational use of medicines and substantially lower health-care costs. The Indian market accounts for 22% of the world market of generic drugs. India is the fourth largest market in terms of production and ranks thirteenth in terms of consumption value of generic drugs.
Physicians always have a choice between original and generic drugs while prescribing them to patients and hence, it becomes crucial to know how health-care providers perceive the differences between the two classes of drugs.
Accordingly, back in 2016, researchers from Mumbai's BYL Nair Charitable hospital analysed the perceptions, and attitudes of health-care providers in a tertiary-care hospital toward generic and original drugs. They found that one of the reasons for elevated drug expenditures is the rising rate of physicians recommending the more costlier original drugs and fewer generic drugs.
“Physicians were doubtful about the efficacy of the generic drugs, which in turn shows the lack of confidence for the use of such drugs and lack of knowledge regarding generic drugs.”
In the study undertaken in 200 participants which included postgraduates and super specialty doctors, about 56% participants perceived that generic drugs are as effective as original drugs.
However, interestingly, when they were asked if they ever experienced difference in quality between the two, 56% participants believed that the generic drugs were not as efficacious. Only 49% of the participants agreed that generic drugs are as safe as original drugs. About 38% participants agreed that most of the generic drugs lack the quality of their branded counterparts. A majority of physicians (94%) considered socioeconomic status of the patient while prescribing medicines. If patient could afford, then majority of participants preferred to prescribe original brand drug against those who referred to prescribe generic drug. Medical representatives and drug company leaflets were the most common sources of drug information,' read the report, penned by Kanchan Singh, Abhishek Phatak and Mugdha Sathe, all researchers from BYL Nair hospital in Mumbai.
