Though our country has been the hub of a number of scams and corrupt systems, there are few things of which we can boast. And one of them is the pharma industry in India. The Indian pharmaceutical industry is presently a one lakh crore industry. We export drugs to more than 200 countries worldwide, and in the period 2008-09, we had exported drugs around 8 billion dollars.
What are Generic drugs?
A generic medicine is identical or bioequivalent version of branded medicine, which is developed and distributed without patent protection; hence they are dirt cheap in cost. The active substances present, the dosage and treatment of the generic drugs are same as the branded drugs only colour, taste, shape or inactive substances may different. The only differences between a generic and a branded medicine might be its name, appearance and packaging.
The active substance of a generic medicine is what gives it its therapeutic effect. The manufacturer can use a stable form of the active substance, like a hydrochloride salt; but this can be done only until the medicine doesn’t lose its activity.
The manufacturing and evaluation of a generic Drugs
Like all other drugs there are quality standards set for the manufacture of generic drugs. And just like in the case of the normal prescribed drugs, periodic inspections happen in the manufacturing sites of the generic drugs, to ensure if GMPs (good manufacturing practices) are maintained.
The prescribed drugs will have been authorised for years, hence information regarding the safety of the active substances it contains is available. The evaluation is made in such a way that the generic medicine is comparable to the branded medicines so that it can receive marketing authorisation.
There is a medical rule that a company producing generic drugs has to provide information on the quality of the medicine. The company will also have to give demonstrations to show that the generic medicine produces the same amount of active substances in the body as the prescribed medicine.
There might be some cases when the generic drugs contain salts of the active substances that are different to that of the prescribed drugs. In such cases, the regulatory authorities check if additional tests are to be done to grant the marketing authorisation to the medicine.
The advantages of Generic Drugs:
One of the biggest merits of generic drugs is the cost factor. The manufacture of a normal medicine is backed by extensive research and advanced medical technology, whereas a generic medicine is nothing but the reverse-engineering of an already existing normal medicine. Hence the cost of a generic medicine comes down drastically. This is also saves health care insurers hundreds of crores of rupees each year.
In addition to saving the pockets of the consumers, generic brand drugs also make required drugs available to large strata of the population which couldn’t afford the drugs in the past. That is, now whether it is the rich or the poor, everyone can have access to high standard drugs. In India, widespread deaths and fast spreading diseases amongst the low class people are very much rampant, and the concept of generic drugs might undeniably put a stop to this.
When it comes to safety, generic drugs call the shots. They are as safe as the normal drugs, and sometimes even safer. Every generic drug needs to undergo clinical trials to prove both safety and efficacy.
Disadvantages of Generic Drugs:
Though there are a number of advantages for the usage of generic drugs, there are also a few disadvantages. First of all, the FDA (Food and Drug Administration) doesn’t see to it that the manufacturers of generic drugs use the same inactive substances as that are used in normal drugs. The inactive substances help to direct the drug to the target organs, and hence the usage of such substances are very much imperative. So even the active ingredient in the generic medicine is the same as the normal drug, if the inactive substance is not present in the reformulated drug, then it may not be effective in delivering the same dose as that of the normal drug.
The FDA doesn’t have the adequate resources to put a watch on the manufacture of generic drugs in foreign countries. Four years ago, the New York Times reported that tens of thousands of people were exposed to a tainted or undesirable ingredient in a generic drug manufactured in China. That Chinese generic drug was never inspected by the FDA before approval of the drug sale in the U.S. Generic drugs are safe and effective as the original drugs, but the consumers should ask questions regarding the place of manufacture and if the generic substitution is safe.
Hence, generic drugs can be the future of medicine and health. And if the action is taken in the direct direction, one day we can succeed in eliminating the phenomenon of illness from our planet at very low cost.