Drugs Price Control in India

LAW LIBRARY

The term “Drug” Includes – (i) all medicines for internal or external use of human beings or animals and all substances intended to be used for, or in the diagnosis treatment, mitigation, or prevention of any disease or disorder in human beings or animals, including preparations applied on human body for the purpose of repelling insects like mosquitoes; (ii) such substances, intended to affect the structure or any function of the human or animal body or intended to be used for the destruction of vermin or insects which cause disease in human beings or animals, as may be specified from time to time by the Government by notification in the official Gazette; and (iii) bulk drugs and formulations.

Bulk drug or Active pharmaceutical ingredients (API) means any pharmaceutical, chemical, biological or plant product including its salts, esters, isomers, analogues and derivatives, conforming to standards specified in the Drugs and Cosmetics Act, 1940 (23 of 1940) and which is used as such or as an ingredient in any formulation.

Generic medicines are unbranded medicines which are equally safe and having the same efficacy as that of branded medicines in terms of their therapeutic value. The prices of generic medicines are much cheaper than their branded equivalent.

A branded generic is a drug that is bioequivalent to the original product, but is now marketed under another company’s brand name. IMS Health, which began tracking and reporting on branded generics in 2002, defines the category as including prescription “products that are either novel dosage forms of off-patent products produced by a manufacturer that is not the originator of the molecule, or a molecule copy of an off-patent product with a trade name.” This definition is used by both the FDA in US and the United Kingdom’s National Health Service (NHS).

ACTS

Essential Commodities Act, 1955 (10 of 1955)

Drugs (Prices Control) Order

REGULATOR

National Pharmaceutical Pricing Authority

Policy

• Uniform Code of Pharma Marketing Practices
• Pharmaceutical Policy 2002
• Drug Policy 1986
• National Pharmaceutical Pricing Policy 2012

Schemes