Quite expectedly, pressure lobbies of medical practitioners in India have started protesting against a recent guideline issued by the National Medical Commission that stipulates prescribing medicines by their generic names instead of one of the brand names. Government instructions to this effect have existed since 2010. The guideline reads: “Every RMP should prescribe drugs using generic names written legibly.” I used the word pressure lobby because so far no scientific evidence has been produced against generic drugs with peer-reviewed research papers to support their claim.
The issue in simple words
All drugs are made of complex chemical compounds. Their proper nomenclature is very difficult. A common drug for reducing fever is, for example, 4’-hydroxyacetanilide or, in the older system, para-acetyl-amino-phenol. In colloquial language, they are called salts (chemically they are not—a salt is the product of an acid and a base) or active ingredients. Most people would not be able to pronounce it, much less remember it. Hence, the simpler name paracetamol was devised by taking ‘para’, ‘acet’ (from acetyl), ‘a’ (from amino) and ‘ol’ (from phenol) and combining them. This is called its generic name.
Most laymen find even that to be difficult. Going by the standard principles of marketing, pharmaceutical companies give brand names to their products. According to medindia.net, paracetamol is sold under as many as 651 brand names. Generic drugs are those that are sold by their generic names and without any brand name. They are generally far cheaper (30% to 80%) than branded drugs. The Pradhan Mantri Jan Aushadhi Yojana, for example, provides generic drugs only. According to Dr Eric G. Campbell, professor of medicine at Harvard Medical School and Massachusetts General Hospital, prescribing a brand-name drug when a generic is available is a huge source of wasteful spending worth billions of dollars that can be prevented.
Brand names must not be confused with drugs with an active patent. To stimulate research and offset the cost of developing new medicines, the Food and Drug Administration, USA allows a company that develops a new drug and holds its patent to be the only one to sell it for a specified period. When that is over, other companies can sell a drug made with the same chemical and have their own brand names.
The protesters say that the quality of generic drugs is doubtful or questionable and they would prefer to prescribe by brand names because they are supposedly more beneficial to the patients and they do not want their reputation to be spoiled.
Where do they falter and how?
The simple scientific question is how anyone of them determined that Brand X is better than Brand Y and that both of them are better than Generic Drug G? They have no answer to this.
Who are mere medical practitioners to claim that the product of Company X is great or that Generic Drug G is bad? Have they conducted a study and published a paper? Obviously not! Why don’t they do it? Nothing prevents them from conducting some systematic, comparative research and publishing papers in peer-reviewed professional journals condemning certain generic or branded products as of poor quality endangering the lives of patients, and extolling some others. They cannot hide behind a vague and unscientific plea that they have found so in their clinical practice. Who cares about their clinical experience? We are talking science here and science does not run on anecdotal evidence even if it comes from a Nobel Laureate, not to talk of a mere medical practitioner.
Legal implications of unsubstantiated allegations
The matter is very serious and has legal implications too. If a medical practitioner condemns a drug that is manufactured legitimately and for which the quality control regime in force has not found any fault, he is under a legal obligation to justify his claim. That is why all such claims and allegations are made vaguely in talks, without mentioning any single product by name, and never on paper. If they have the intellectual courage, let them make such claims or allegations on paper and then they will see how the companies maul them in court.
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There is a moral dimension too. Should the generic drugs really be found to be of dubious quality, it would also mean a very serious corruption or systemic faults in the quality control regime that is endangering the lives of millions of people. Why are they failing in this duty towards society?
The rationale behind prescribing Generic drugs
First, it ensures that medical practitioners do not derive their knowledge from medical representatives selling certain brands. Second, it ensures that they still remember the principles of medicine. Third, given the sheer number of branded drugs (nearly 48,000 brands in India) and confusing/similar names for vastly different drugs, prescription by generic name reduces the chances of errors in prescribing and selling by those drug stores that usually do not have qualified staff at the counters. Fourth, it is the standard practice in many countries of the world. Australia, for example, has legislation called National Health (Pharmaceutical Benefits) Amendment (Active Ingredient Prescribing) Regulations 2019. According to the FDA Office of Generic Drugs 2021 Annual Report, 90% of the drugs prescribed in the USA are now generic. Fifth, though not stated explicitly, it seeks to discourage corruption in medical practice where medical practitioners go out of the way to promote certain pharma companies in return for a myriad of benefits.
Not one but several studies in the world (such as those by Aaron Kesselheim et al; Rishi Desai et al; and Yuxi Tian et al) have conclusively proved that generic drugs give the same clinical outcomes as branded drugs. The studies covered a whole range of drugs such as beta-blockers, diuretics, calcium-channel blockers, statins, antiplatelet agents, ACE inhibitors, alpha-blockers, anti-arrhythmic agents and warfarin for a variety of diseases like hypertension or heart failure and hyperlipidemia, etc.
Determinants of the quality of drugs
Pharmaceutical quality, which generally depends on manufacturing standards, is defined and tested in several ways. Quality standards are published periodically in pharmacopoeias of the respective countries and also by the WHO, which publishes the International Pharmacopoeia. The pharmaceutical qualities are generally assessed in terms of the product’s compliance with the specifications regarding identity (that is, the presence of the API-active pharmaceutical ingredient), its purity, strength or potency (usually, between 90 to 110% of the stated value), and some other characteristics, such as content uniformity, degradation products, residual solvents, drug release or dissolution, moisture content, microbial limits, and physical attributes such as colour, shape, size, odour, score configuration, and friability (the tendency of a solid substance to break into smaller pieces under duress or contact, especially by rubbing), etc.
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The bioavailability of a drug refers to the speed and completeness with which a drug administered in its given form (tablet, injection, etc.) enters the bloodstream. This depends on factors like solvents, binders, colouring agents, coatings and how the ingredients are combined. Some preparations, for example, may release their API too quickly, too slowly or even incompletely. Two drugs are said to be bioequivalent if they release the API at the same rate and to the same extent. Another parameter is stability, that is, retention of its properties under the given storage conditions. Yet another parameter is the presence of harmful contaminants or microorganisms, particularly for injectable drugs and syrups.
Unholy nexus of big pharma and medical practitioners
This nexus, though well-known for decades was first exposed in a devastating and methodical manner by Dr. Marcia Angell in 2004 in her book, ‘The Truth about the Drug Companies: How they deceive us and what to do about it’. Dr Angell had been the editor-in-chief of the prestigious The New England Journal of Medicine for a long time. A graduate of the Boston University School of Medicine, she is now a faculty member at the Harvard Medical School. Inspired by her, subsequently many honest scientists in the West did their own research and contributed to our understanding of the ways in which the drug industry is looting the common man.
Dr Angell has exposed the drug industry’s exaggerated claims of producing new drugs and its barrage of media marketing disguised as consumer education. She shows that actually, Big Pharma’s main business is in producing what are called “me too” drugs, that is, merely variations of old drugs created to prolong patent rights and to grab market share. She reveals that the litany of charges includes paying kickbacks to doctors, engaging in anticompetitive practices, colluding with generic companies to keep generic drugs off the market, illegally promoting drugs for unapproved uses, and engaging in misleading direct-to-consumer advertising.
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In his famous book ‘On the Take: How Medicine’s Complicity with Big Business Can Endanger Your Health’, Dr Jerome P. Kassirer (nephrologist at Tufts University School of Medicine and former editor-in-chief of the New England Journal of Medicine) says ‘these physicians have become whores, who sell their intellectual integrity for money’. According to a study (2019) in the Journal of American Medical Association Network, the US pharma industry spends $20.3 billion on marketing directly to healthcare professionals! According to a study by Dr Adriane Fugh-Berman, associate professor at Georgetown University Medical Center in Washington and Shahram Ahari (himself a former representative of the giant pharma company Eli Lilly), this ranges from dinners at the finest restaurants to so-called ‘unrestricted educational grants’ (equivalent of cash payment). Bruce Psaty of the University of Washington wrote in JAMA of families taken out to first-class resorts under the flimsy pretext of some non-descript conference, costly gifts and grants in the range of $5 million.
In India, for want of such studies, even as everybody knows this obnoxious racket very well, I would confine myself to an observation of the then-union health minister in 2010, “It has been found that doctors prescribe expensive antibiotics and painkillers produced by multinational pharmaceutical companies even though there are generic alternatives. It often transpires that these companies sponsor foreign jaunts, shower gifts or give a commission to the doctors. This is an unhealthy practice and we want to stop this.”
Big Pharma exploits the people so much through exorbitant pricing that despite 90% of the prescriptions being generic in the USA, according to statista.com, generics account only for 16% of the expenditure on drugs with the remaining 84% still held by branded drugs.
Unscientific Criticism is Malicious
As a scientist, I firmly believe that scientists must have an open mind. Those who are opposing generic drugs are under an obligation to produce peer-reviewed research papers with analyses carried out both in labs of international repute as well as government labs. This is necessary because even the integrity of a lab could be compromised. The matter must then be placed before the public, legislature and the judiciary for appropriate action. Bereft of such evidence, a sweeping criticism of generic drugs only exposes the unholy nexus of medical practitioners with the pharmaceutical industry, and they stand to lose whatever social respect they command.
I am aware of the recent incidents of deaths of several kids abroad by substandard cough syrups that were, incidentally not generic. Apparently, they were contaminated with industrial solvents and antifreeze agents. This is an issue that calls for more stringent quality controls and regulatory oversight. Isolated incidents like these cannot be used for condemning generic drugs per se. The Central Drugs Standard Control Organisation, for example, has proposed testing cough syrups in government laboratories before they are exported.
India is indeed the ‘pharmacy to the world’, being the largest provider of generic medicines, producing 20% of the world’s supply. Our $50 billion pharmaceutical industry exports medicines to over 200 nations and makes 60% of all vaccines. We cannot allow vested interests and unholy nexuses to sully our international reputation.
