Introduction

A generic drug is a pharmaceutical drug that contains the same chemical substance as a drug that was originally protected by chemical patents. Generic drugs are allowed for sale after the patents on the original drugs expire. Because the active chemical substance is the same, the medical profile of generics is believed to be equivalent in performance. A generic drug has the same active pharmaceutical ingredient (API) as the original, but it may differ in some characteristics such as the manufacturing process, formulation, excipients, color, taste, and packaging.

Many Indian doctors’ disfavor generic drugs for two main reasons: more people have a better awareness of branded drugs in both urban and rural areas, even if they are more expensive; and because doctors often receive a ‘commission’ from drug-makers for prescribing particular branded drugs. Medical shop owners also receive kickbacks and have been known to push branded drugs for this reason.

The generic drug is bioequivalent to the branded product, meaning there is either no significant difference between the two drugs in terms of the rate and extent of absorption or if there is a difference, it is either intended or not medically significant.

So long as the FDA criteria are met, a generic drug may be marketed when the patent protections ends or the patent owner waives its rights. The competitive nature of the drug market means that once the generic drug is available, the cost of the drug is substantially lowered for both the original brand name product and the generic drug.

Marketing of generic drugs

Generic drugs neither hamper nor discourage innovation. In fact, they should be marketed more aggressively so that people can afford good-quality healthcare. The Government of India launched the Pradhan Mantri Bhartiya Janaushadhi Pariyojana in 2008, under which it would provide good-quality generic drugs at affordable prices. Thus far, it has opened 7,290 distribution centres around the country; there should be more.

A series of scandals around the approval of generic drugs in the late 1980s shook public confidence in generic drugs; there were several instances in which companies obtained bioequivalence data fraudulently, by using the branded drug in their tests instead of their own product, and a congressional investigation found corruption at the FDA, where employees were accepting bribes to approve some generic companies' applications and delaying or denying others.

In 2007, North Carolina Public Radio's The People's Pharmacy began reporting on consumers' complaints that generic versions of bupropion (Wellbutrin) were yielding unexpected effects. Subsequently, Impax Laboratories's 300 mg extended-release tablets, marketed by Teva Pharmaceutical Industries, were withdrawn from the US market after the FDA determined in 2012 that they were not bioequivalent.

The socio-economic impact of COVID-19 has been such that the common person’s capacity to spend has come down on average. At this time, but also in general, the people need to be vigilant and know their rights. They should always request their doctors for generic drugs where possible; if there are no alternatives, they should discuss their concerns and needs with their doctors. Doctors should also be more conscious of their obligations and do their part to improve access to healthcare.

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Regards,

Mary Wilson,

Editorial office,

Clinical Pharmacology and Toxicology Research

E-mail: pharmatoxicol@eclinicalsci.com