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India’s Generic Medicines – The Rationale Behind the Mandatory Prescription Policy

Since PM Modi’s assumption of power as head of the government of India, the prescription of generic medications has become mandatory throughout the country. Actually, India is ranked as the third largest leading producer of generic medicines worldwide, with nearly 50% of generic medicines available in the US, outsourced from india.

In the country, almost half of all generic medicines are manufactured by the same pharma companies that produce leading branded versions of mainstream generic drugs. The government explained that the reason generic drugs are manufactured, is to bring down costs by 30 up to 80 percent. That way, non-branded medicines that have the same bioequivalence as their branded counterparts can reduce the out-of-pocket-expenses for medicines shouldered by Hindustani households.

To make sure sale and distribution of generic drugs are controlled, a private pharma company mediates and curates deals entered by generic drugstore owners with drug manufacturers. The distribution and selling arrangements with dedicated health ambassadors, is by way of a monopoly covering a particular geographic location — and for a broad range of generic medicines in tablet, capsule, syrup, topical creams or injectable forms.

To alleviate doubts over the efficiency of generic drugs, the Drugs Controller General of India (DCGI), the India Food and Drug Administration (FDA) and the Food Safety and Standard Authority of India (FSSAI) perform respective duties in testing and evaluating the generic medicines before they are released to pharma franchise dealers.

When is a Branded Medicine Eligible for Generic Production

Ordinarily, proprietary drugs manufactured by pharma companies are protected by a patent that gives them the right to exclusively produce, market and sell the drug under a specific brand name. However, the patent protects the exclusivity right, up to a specific period of time. This denotes the need to apply for a patent renewal if looking to extend the rights to the use of the brand name.

Take note that the patent exclusivity applies only to the brand name but not the right to produce the medicine. Once the patent has expired, other pharma companies can produce copies of the medicine using the same formula and active ingredients; but with a different color, size and shape.

Since they have the same components as the original branded medicine, the generic medicines must be available in the same dosages, e.g. 500 mg, 1000 mg. Such conditions reduce the cost of manufacturing medicines, which in turn reduces the prices by which they are sold.

What Exactly does Bioequivalence Mean

Bioequivalence means that when two medications are compared, they produce the same physiological results in the user because they have been tested to be bioequivalent; or having the same bioavailability of active pharmaceutical ingredients. Moreover the two medicines work under the same conditions used in testing the efficiency of both medicines in achieving similar peak blood aggregation.