The cost of prescription drugs has always been a source of concern for patients, especially from economically weaker sections. Generic medications are drugs created with the same ingredients as brand-name drugs. The code of ethics issued by the Medical Council of India in 2002 calls for physicians to prescribe drugs by their generic names only. The solution to the problem of branded versus generic drugs lies in strengthening the existing quality control structure. In the United States, 9 out of 10 prescriptions filled are for generic drugs. Increasing the availability of generic drugs helps to create competition in the marketplace, which helps to make treatment more affordable and increases access to healthcare for more patients. In 2014, the use of generic drugs in the United States led to US$254 billion in health care saving. In 2011, the Department of Pharmaceuticals came up with a Uniform Code for Pharma Marketing Practices (UCPMP) to arrest the unethical marketing practice of bribing of doctors by pharmaceutical companies.
It is a well-known fact that promotion of drugs by way of direct cash payments for prescribing, or by sponsoring of pleasure trips and other incentives to doctors contribute to more than 20 percent of the price of medicines. The recent directive of MCI under Code of Medical Ethics 1.5 states: “Every physician should as far as possible prescribe drugs with generic names and he/she shall ensure that there is a rational prescription and use of drugs”. However, it creates confusion between the terms “generics” and “generic names.” By default, most drugs sold in India are generic. However, they are marketed under a brand name given by the manufacturer. This directive passes the onus of selecting the brand name of drug and manufacturer to the pharmacist, as is the practice in Europe and many developed countries. This guidance is downplayed by the Registered Medical Practitioners of India, stating that this guidance will put the health of patients in the hands of pharmacist instead of the physician. Laudable theoretically, this guidance does not fit in the not-so-robust drug regulatory system of our country which is struggling to provide quality medicines from all manufacturers. Once the regulatory apparatus is empowered with adequate manpower and facilities, this directive will be a welcome contribution toward rational prescription writing.
According to the FDA, a generic drug is a product that compares to the pioneer, or reference, drug product (usually a branded drug) in dosage form, route of administration, strength, quality, safety, and performance characteristics. The generic drug must have the same intended use as the brand product that serves as its prototype.
The English dictionary defines the word generic as: “Not protected by trademark registration, non-proprietary, or any product, as a food, drug, or cosmetic that can be sold without a brand name”. In medicine, it pertains to the salt name or active ingredient of a drug delivery form, e. g., Tablet “Obimet-500” manufactured by Abbott India has active ingredient “Metformin”, the chemical name of which is 1,1Dimethylbiguanide Monohydrochloride. Chemicals are given non-proprietary name by the WHO, which is the unique name of the drug. Brand names are registered and are protected by trademark law.
A generic drug has the same API as the original, but it may differ in some characteristics such as the manufacturing process, formulation, excipients, colour, taste, and packaging.
Generic medications are drugs made to work exactly the same way that brand-name drugs work but are often cheaper. Although they may not be associated with a particular company, generics are usually subject to government regulations in countries in which they are dispensed. They are labelled with the name of the manufacturer and a generic non-proprietary name. The US FDA requires generics to be identical to or within an acceptable bioequivalent range of their brand-name counterparts, with respect to pharmacokinetic and pharmacodynamic properties.
Bioequivalence does not mean generic drugs must be exactly the same as the brand-name product (pharmaceutical equivalent). Chemical differences may exist; a different salt or ester may be used, for instance. Different inactive ingredients mean that the generic may look different from the originator brand. However, the therapeutic effect of the drug must be the same (pharmaceutical alternative). Most small molecule drugs are accepted as bioequivalent if their pharmacokinetic parameters of area under the curve and maximum concentration are within a 90% confidence interval of 80% to 125%; most approved generics are well within this limit.
Once generics enter the market, competition often leads to substantially lower prices for both the original brand-name product and its generic equivalents. In 2014, according to an analysis by the Generic Pharmaceutical Association, generics accounted for 88% of the 4.3 billion prescriptions filled in the US. Generics are usually sold for significantly lower prices than their branded equivalents and at lower profit margins. Generic companies incur fewer costs in creating generic drugs – only the cost of manufacturing, without the costs of drug discovery and drug development – and are therefore able to maintain profitability at a lower price. The prices are often low enough for users in less-prosperous countries to afford them. For example, Thailand has imported millions of doses of a generic version of the blood-thinning drug Plavix (used to help prevent heart attacks) from India, the leading manufacturer of generic drugs, at a cost of US$0.03 per dose.
Generic drugs provide an immense amount of savings for consumers. The amount of money saved through generic usage has more than doubled since 2008. The availability and utilisation of generic alternatives to brand-name drugs have had a significant effect on cost savings for health care consumers. In 2008, generic drugs accounted for more than 63% of total prescriptions filled in the US. Although generics are used to fill the majority of prescriptions, the actual costs associated with these medications are less than 13% compared with their branded counterparts. While direct cost savings are a significant advantage for generic drug products, studies have also shown improvements in indirect costs such as therapy adherence and compliance.
India is a leading country in the world’s generic drugs market, with Sun Pharmaceuticals being the largest pharmaceutical company. Indian generics companies exported US$17.3 bn worth of drugs in the 2017-18 (April-March) fiscal year. India exported US$20.0 bn worth of drugs in the 2019-20 fiscal year.
The branded versus generic debate is an ongoing one, with various stakeholders actively involved. The relative merits of branded and generic drugs have been discussed, with varying opinions. Quality, efficacy, safety, and economy are some aspects which are presumed to differ between branded and generic formulations.
The practice of endocrinology makes ample use of generic medicines and recombinant hormones. Endocrine and metabolic pharmaceutical preparations may be more complex than those used in other fields of medicine. Metformin sustained release and gliclazide modified release have pharmacokinetic properties which are different from immediate release formulations. MR formulations for generic molecules are used extensively in endocrinology and in many cases generic formulations may not be able to mimic the characteristics of innovator formulations. This aspect must be kept in mind while crafting prescriptions. Generic counterparts of biological agents are called biosimilars.
Endocrinology also utilises other hormones which are available as both innovator and generic products. Lthyroxine is one such frequently used molecule. There are serious bioavailability issues and significant brandtobrand variation in case of levothyroxine where interchanging brands is not advisable. A joint statement by American Association of Clinical Endocrinologists, The Endocrine Society of America, and American Thyroid Association recommends use of same brand of levothyroxine in patients.
The directive by MCI or any other regulatory body promoting writing of generic names only should be evaluated carefully by the practising clinician. Patient safety must be given paramount importance. Every effort should be made by professional bodies to achieve syncretism with government regulations based on an in-depth understanding of issues involved.
The solution to the problem of branded versus generic lies in strengthening the existing quality control structure of the country. The strategy can be two-pronged: an increase in the capacity of existing labs, and opening up of new laboratories in government colleges. Pharmacology departments of existing medical colleges can play a big role in this direction. The public sector (Jan Aushadhi scheme, hospitals etc.) should procure medicines from firms which quote lowest price (existing practice) along with in-house quality control reports of each batch of medicines supplied. These firms must be subject to external audit and quality control as well.
The CDSCO is the pivotal agency dealing with all drug related issues. It deals with all new drug approvals, review of new safety information regarding approved drugs, approval and safety review of FDCs, medical devices and implants. All endocrine and metabolic drugs are covered by these organisations and acts. Food supplements (including many herbal products) are regulated by separate laws since they are legally not considered drugs.
The writer is Member Secretary to J&K Pharmacy Graduates Association. [email protected]