Insights into Editorial: Cheap generic vs costly branded: Issues in picking right drug in India
The central government is planning to bring a legal framework under which doctors will have to prescribe generic medicines which are cheaper than equivalent branded drugs, to patients. If a doctor writes a prescription, he has to write in it that it will be enough for patients to buy a generic medicine, and he need not buy any other medicine.
Interestingly, this is not a new intervention. MCI has already notified an amendment in Clause 1.5 of the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002. This clause now reads: “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”. The words “legibly and preferably in capital letters” were not there originally.
What are generic drugs?
A generic drug is identical — or bioequivalent — to a brand name drug in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use. Although generic drugs are chemically identical to their branded counterparts, they are typically sold at substantial discounts from the branded price.
What exactly is the difference between a generic drug and brand- name drug?
When a company develops a new drug — often after years of research — it applies for a patent, which prohibits anyone else from making the drug for a fixed period. To recover the cost of research and development, companies usually price their brand- name drugs on the higher side. Once the patent expires, other manufacturers duplicate and market their own versions of the drug. Since the manufacture of these generic drugs do not involve a repeat of the extensive clinical trials to prove their safety and efficacy, it costs less to develop them. Generic drugs are, therefore, cheaper.
However, because the compounds in the generic versions have the same molecular structure as the brand-name version, their quality is essentially the same. The generic drug has the same “active ingredient” as the brand-name drug. This ingredient is the one that cures the patient; and other, “inert ingredients”, which give the drug its colour, shape or taste, vary from the brand-name drug to the generics. In the United States, the Food and Drug Administration notes that the cost of a generic drug is 80% to 85% lower than the brand-name product on average.
Why aren’t generic drugs more popular?
There are various reasons for their unpopularity. There is a distinct lack of awareness about them. Also, since they are cheap, people who can afford branded drugs don’t buy them believing them to be of inferior quality. Chemists have to hand out exactly what’s written on the prescription and most doctors except in government hospitals don’t hand out generic drugs.
- Also, private doctors never hand out generic drugs because there are no kickbacks or incentives involved from pharma companies.
- The government or specifically the government’s Department of Pharmaceuticals is also to blame for the lack of awareness.
Experts say it will be misleading to presume that prescriptions with generic names will automatically translate into lower medicine bills for patients. There are many challenges:
- This is a well-intentioned but impractical proposal. But, the existing drug market in the country makes it hard to implement. Almost all medicines sold in India have brand names, including generic medicines with brands.
- Some doctors who have tracked the pricing of drugs have cautioned that the trade margins for branded generic medicines are at times even higher than the margins for branded medicines from the same companies.
- About 40% of the estimated 60,000 drug formulations sold in India are fixed dose combinations, or FDCs, of multiple pharmacological ingredients which are only sold through brand names.
- A study has found “significant variations in drug concentrations and physical properties” of generic formulations of latanoprost, a medicine used to treat glaucoma, an eye disorder.
- Also, prescriptions with generic names only had the potential to compromise patient safety because the choice of the medicine to be handed over to patients would shift from the doctor to the retail chemist.
How can the government ensure that generics, apart from being cheap, are also safe for the patient?
Experts say the priority of the government should be to bring a legal framework to ensure “quality” in generic drug testing. No more than 1% of generic drugs sold in India undergo quality tests. Generic drugs should work “therapeutically” and the government should ensure “uniform quality”, experts say — only then can doctors prescribe them with confidence.
- Also, the government has to clarify how it will ensure that once a doctor prescribes the generic drug, detailing its medical composition, the pharmacist or chemist will give the most appropriate drug to the patient. Even on the question of price, studies have shown that it is the retailer’s margin that often plays the key role in deciding how much the patient pays for a drug.
- Making it incumbent on the doctor to prescribe a generic drug would mean that the prescription will detail the medicine’s composition — the salts — leaving the choice of the brand on the patient. However, for such a choice to be effective, the proposed law needs to go beyond the doctor-patient binary and target each link in the pharma industry’s chain of corruption.
- 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. A patient armed with a prescription detailing the composition of the medicine could still be dependent on a pharmacist to make the most suitable drug choice for her. And by all accounts, a pharmacist is likely to be even less sensitive to a patient’s medical — and financial — condition than the doctor. The efficacy of the proposed law will hinge on the ways in which it brings pharmacists — and not just doctors — under its ambit.
- 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 labelling and inadequate quantity of ingredients. Ensuring quality of drugs is a problem in the absence of adequate regulations and shortage of drug inspectors and lab facilities to check drug quality. The number of drug inspectors — approximately 1,500 now — must be increased.
Though the Medical Council of India had by way of an amendment to the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations 2002, issued directives to the doctors to preferably prescribe generic drugs, nothing changed. Implementational problems, non-commitment and non-effective strategies to materialise its order, has douched the medical body into controversies. It’s functioning too has been far from effective. It is, therefore, not surprising that no headway has been made on this matter. Now that the Government has taken up this issue, it should swing into action and ensure that promises are kept and provisions implemented.