Prime Minister Narendra Modi has exhorted doctors to prescribe medicines using their generic names only and hinted that the government will enact a comprehensive legislation.
There is nothing new about this pronouncement even as the need for giving a push to use of generic medicines and drugs has been in the air for close to five decades ever since the Patent Act [1970] was passed by the parliament. Last year, the Medical Council of India [MCI] which is expected to keep a watch on doctors had amended the relevant rule ‘mandating doctors to prescribe using the generic name to ensure a rational prescription and use of drugs.’
Modi’s proclamation catapults the issue to the centre-stage. Already, the union ministry of health and family welfare is preparing a ‘regulatory framework’ to ensure that in labeling on packs and accompanying leaflets besides doctor’s prescriptions, generic names get greater prominence than the brand names of medicines. The intent is to ensure that labels carrying generic names of medicines are in a font size much larger than their brand-name.
The aggressive push for generics is prompted by government’s concern over high price charged by manufacturers of branded medicine which in turn, is due to collusion between them and the doctors. Under a quid pro quo arrangement between the two, the doctor prescribes medicine of particular brand/company who in return, gives all kinds of allurements [including monetary benefits] to the former.
Given that the hapless patient has no option but to follow doctor’s advise, this tacit collaboration continues unabated leading to unjust enrichment of the duo. Further, since prescriptions are invariably written in clumsy handwriting [which only chemist can understand] exacerbates this unethical practice. This has a hugely destabilizing impact on the budget of even a middle-class family not to talk of a poor household – as aptly described by the prime minister.
There can be no disagreement on the urgent need to counter this pernicious practice. But, the question we need to ask is whether a mere act of requiring doctor to prescribe medicine via generic name will solve the problem? The answer is an emphatic no.
Prescribing generic names would merely shift “decision making” from doctor to the chemist who may not understand scientific rationale or have the best interest of the patient in mind. In that scenario, manufacturers will start lobbying with chemists whom they will find more amenable than the doctor. The chemist will recommend to patients only those brands/companies who offer higher margin plus other benefits [albeit hidden].
Under the extant dispensation, while, prescribing a particular brand, the doctor authenticates the quality [implicit in writing the prescription] taking in to account credentials of manufacturer as also feedback received from patients. By asking him/her to write only generic name, the government would have ended up dismantling this important quality assurance mechanism.
Nearly 50% of medicine market in India is made up of combination drugs i.e. medicines with two ingredients or more. The doctor is best equipped to determine which brand offers an efficacious combination product. If, the doctor were to prescribe generics only and the chemist is expected to decide a product that has these ingredients in required proportion, this would be disastrous.
Putting the ball in chemist’s court will also exacerbate the menace of spurious medicines which is already a major headache for the authorities. This stuff gets space wherever patient makes purchases without doctor’s prescription. Now, with doctor mentioning only generic name in the prescription, the chemist would get extra room for maneuverability and even patients buying with doctor’s prescription are likely to be duped.
So, what needs to be done? What is the way forward? For a proper diagnosis of the malady and solutions thereof, at the outset, we need to have a clear understanding of the fundamental difference between a branded medicine and its generic counterpart.
Strictly speaking, the nomenclature ‘branded’ is associated with an innovator company which spends huge resources on discovery of a new molecule [ingredient in the medicine] and thereafter, on its development and commercialization. This company also has the responsibility of promoting rational and scientific use [‘stewardship’ in short] of the medicine. It has an unflinching commitment to maintaining quality in the entire supply chain – from manufacturing, stocking, marketing and distribution to actual use.
Invariably, this company also holds a patent on the new medicine in various jurisdictions. Considering huge expenses on R&D, securing product registration [money spent on ‘safety’ and ‘efficacy’ studies without which approval cannot be granted] and stewardship, it has to necessarily set price at a higher level so that these costs can be amortized.
By contrast, a generic drug is identical or bio-equivalent of original stuff. The manufacturers of generics do not need to spend on R&D and studies to demonstrate their safety and efficacy – as this is already done by the innovator [indeed, the regulator relies on his/her studies for granting market approval to generic companies]. So, they can afford to price it low and yet, make good profits from sale.
The new medicines can be promoted only on the strength of what they offer vis-à-vis medicines – with similar therapeutic effects – already available in the market. For these, there cannot be any quid pro quo between doctor and the company. Further, it makes no sense to insist on ‘generics’ prescription only as identical/bio-equivalents [read generics] cannot simply be allowed during initial phases of launch till its proper and scientific use is fully established.
Over 90% of medicines sold in India are out of patent. These are not new and since high R&D and registration cost have already been recuperated, the innovator cannot justify higher price. For these drugs, individual companies – even in generic space – have developed brands [an apt euphemism would be ‘branded generics’] based on their manufacturing, testing and quality assurance capabilities.
Herein, there could be scope for collusion between company/doctor duo with an intent to charge more from patients. But, issuing a gag order to prescribe generics will only boomerang. The only way to break their nexus is to promote competition among various brands to ensure that a plenty of these are available within a reasonable price range. At the same time, doctors should be goaded to be more sensitive to the price aspect while writing prescription.
Yet, some dubious characters will always exist. The best way to deal with them is to mount surveillance to nab them. The sector regulators viz. MCI, National Pharmaceutical Pricing Authority of India [NPPAI], Drug Controller General of India [DCGI] should effectively enforce rules to achieve this objective. The government must not tamper with a time tested system just because these agencies are not doing their job properly.