The Hindu Business Line : There's a general urge to move to generic drugs

EVEN as the Prime Minister's office is busy working on a policy to develop `a world-class pharmaceutical industry', one can hear wails over the payment of reasonable royalty by generic drug manufacturers to patent-holders, courtesy an overflowing mailbox and exclusive marketing rights.

A few days ago, the IPA or the Indian Pharmaceutical Alliance, `a platform for the big daddies of the domestic drug industry', was upset at a suggestion in a discussion paper from the taskforce set up by the PMO, that doctors prescribe only generic medicines in certain categories. Such a move will not empower the consumer but only shift unethical promotions from doctors to the trade, argued the industry body. To outdo the generic angle, there was even an industry suggestion that a one-per cent health cess be levied on the earnings of the entire gamut of the healthcare industry to subsidise medicines for the less privileged.

Thus, we find the issue of `generic drug' moving from chemical to health to finance departments, but we aren't alone. "Gov't to reduce costs with switch to generics," reads the headline of the day's story in Budapest Business Journal (www.bbj.hu). It cites József Hamvas, head of the pharmaceutical and medical technology department at the Health Ministry, explaining that as of January, "doctors will be required to write the International Non-proprietary Name (INN), or generic name, on prescriptions, rather than the brand name of a particular drug".

INN designations facilitate the identification of pharmaceutical substances or active pharmaceutical ingredients, and each INN is a unique name that is globally recognised and is public property, informs the site.

"Japan, the world's second-largest pharmaceutical market, is set to increase its use of generic drugs in the coming years as the government seeks ways to rein in healthcare costs," reports a July 5 posting on www.pharmalive.com. "A new system of reimbursing medical drug costs could save the Government millions of euro a year," notes a July 11 story about the Irish scene on http://breakingnews.iol.ie. "The Association of Pharmaceutical Manufacturers of Ireland (APMI) said drug reimbursement schemes cost the Government more than — 1bn a year and making greater use of generic drugs would cut millions from that figure."

Generic drug has also been in the news for such happy instances as Aurobindo Pharma getting the US FDA nod for its generic AIDS combo drug, and Ranbaxy obtaining a tentative regulatory okay for its generic drug.

What is `generic drug'? It is a drug that is bioequivalent to a brand name drug with respect to pharmacokinetic and pharmacodynamic properties, but is normally sold for a lower price, explains Wikipedia. Simply put, it is a drug sold under the name of its active chemical ingredient. For example, Ampicillin, the chemical name of a commonly prescribed antibiotic may be available as different brand names such as Roscillin and Albercilin.

"Generic medicines must contain the same active ingredient at the same strength as the `innovator' brand, be bioequivalent, and are required to meet the same pharmacopoeial requirements for the preparation. By extension, therefore, generics are identical in dose, strength, route of administration, safety, efficacy, and intended use," adds http://en.wikipedia.org. "Although generic drugs are chemically identical to their branded counterparts, they are typically sold at substantial discounts from the branded price," states the Office of Generic Drugs (OGD) of the Centre for Drug Evaluation and Research (www.fda.gov/cder/ogd). Generic drugs save the US consumers an estimated $8 to $10 billion a year at retail pharmacies, and even more billions are saved when hospitals use generics, adds the URL.

The abbreviation ANDA stands for abbreviated new drug application, submitted for approval to market a generic product. However, the US regulator studies the bioequivalence or the rate at which the drug is absorbed in the bloodstream before a generic drug is given approval.

Please note, "switching from a brand drug to a generic counterpart can be accompanied by a 3.5 per cent change in blood levels," as a recent posting on www.timesleader.com cautions. "For most drugs, this difference is minute and does not make a difference in way the drug affects your body," is, however, a reassuring line. "If a patient is being treated for a non life-threatening disorder with an agent that has a wide therapeutic window, whether generic-proprietary or generic-generic bioequivalence is true, clinical equivalence may not be critical," is some medical-speak available on www.americanheart.org.

"Generic drugs are less expensive because generic manufacturers don't have the investment costs of the developer of a new drug. New drugs are developed under patent protection. The patent protects the investment — including research, development, marketing, and promotion — by giving the company the sole right to sell the drug while it is in effect," explains the OGD. Thus, generally, cutting edge companies may like to invest in R&D to develop new drugs, rather than manufacture generic drugs.

Ask a marketer and he'd tell you how when brands die, the product becomes a commodity. Similarly, when patents expire, drugs turn generic. An interesting report, therefore, is the one titled `Generic Drug Entry Prior to Patent Expiration' available on www.ftc.gov, the Web site of the US the Federal Trade Commission. The drug industry also speaks of `branded generics' as identical copies of the original drugs, manufactured after the brand's patent is over. The Web site www.netdr.com has this to postulate on the Indian situation: "Eli Lilly's Cialis (a medicine which cures erectile dysfunction) competes with more than ten branded generics. Once Eli Lilly gets the patent other players will have to withdraw their branded generics from the market." The phrase `generic-generic' drug may seem to have built-in redundancy, but it refers to what is sold on the molecule name. With the Indian market said to be skewed heavily towards the branded generic side, not without attendant cost differential, the proposal of moving towards generic-generic has advantages for the consumer.

"If generic drugs and brand-name drugs have the same active ingredients, why do they look different?" reads a consumer-friendly question on a FDA FAQ. "Generic drugs look different because certain inactive ingredients, such as colours and flavourings, may be different. These ingredients do not affect the performance, safety or effectiveness of the generic drug," assures www.fda.gov.

Generic drug manufacturers can wait for a drug to go off patent and then start selling the generic version or make a Para IV filing under the Hatch Waxman Act, in the US, to challenge an existing patent holder, is a clue from www.netdr.com.

"Litigation is an inevitable part of making a Para IV filing against an existing patent holder (on the basis of loopholes the firm finds in the patents which are listed out in `Approved Drug Products with Therapeutic Equivalence Evaluation,' popularly known as the Orange Book."

Catch up also with the UK law by reading the `Health Service Medicines (Control of Prices of Specified Generic Medicines) Regulations 2000' available on www.dh.gov.uk.

The site www.avert.org of a UK-based charity `with the aim of AVERTing HIV and AIDS worldwide' has a Q&A on generic drugs. It informs that the major countries producing generics are Canada, Brazil, South Africa, China and Singapore, and that the biggest producer of generics is India. "Not only do Indian companies make the finished tablet form of drugs, they also produce cheap generic versions of the raw ingredients and chemicals used in their manufacture, many of which are actually exported to major multinational companies to produce their brand-named versions."

To conclude, it would be apt to remember William Osler's quote — that medicine is a science of uncertainty and an art of probability — while the business of drugs is wrapped in uncertainty. It is quite probable that a people-friendly policy may draw upon the wisdom of Plutarch that medicine, to produce health, must examine disease, as much as music, to create harmony, must investigate discord. For, to sacrifice generic interests, by yielding to corporate lobbies, may get branded as anything but benevolent.

ZeroBase@TheHindu.co.in

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