Generic drugs

  • A generic drug is a pharmaceutical drug that is equivalent to a brand-name product in dosage, strength, route of administration, quality, performance and intended use, but does not carry the brand name.
  • The generic drug may differ from the original in non-essential characteristics such as colour, taste and packaging. Although they may not be associated with a particular company, generic drugs are usually subject to government regulations in the countries where they are dispensed. They are labelled with the name of the manufacturer and a generic non-proprietary name.
  • A generic drug must contain the same active ingredients as the original brand-name formulation.
  • In most cases, generic products become available after the patent protections afforded to a drug's original developer expire.
  • Generic medicines tend to cost less than their brand-name counterparts because they do not have to repeat animal and clinical (human) studies that were required of the brand-name medicines to demonstrate safety and effectiveness. In addition, multiple applications for generic drugs are often approved to market a single product; this creates competition in the marketplace, typically resulting in lower prices.

To increase the use of generic drugs in India, government has initiated the Jan Aushadhi Campaign. The objectives are:

  • Promote greater awareness about cost effective drugs and their prescription.
  • Make available unbranded quality generic medicines at affordable prices through public-private partnership. 
  • Encourage doctors, more specifically in government hospital to prescribe generic medicines. 
  • Enable substantial savings in health care more particularly in the case of poor patients and those suffering from chronic ailments requiring long periods of drug use.

Practice question

 1. Which of the following is/are the functions of the National Pharmaceutical Pricing Authority?

     1.To implement and enforce the provisions of the Drugs (Prices Control) Order in accordance with the powers delegated to it.

     2.To monitor the availability of drugs, identify shortages, if any, and to take remedial steps.

     3.To render assistance to the Central Government in the parliamentary matters relating to the drug pricing.

Codes:

a.  Only 1

b.  1 and 2

c.  2 and 3

d.  All

Ans: d

Exp: The functions are:

  • To implement and enforce the provisions of the Drugs (Prices Control) Order in accordance with the powers delegated to it.
  • To deal with all legal matters arising out of the decisions of the Authority.
  • To monitor the availability of drugs, identify shortages, if any, and to take remedial steps.
  • To collect/ maintain data on production, exports and imports, market share of individual companies, profitability of companies etc, for bulk drugs and formulations.
  • To undertake and/ or sponsor relevant studies in respect of pricing of drugs/ pharmaceuticals.
  • To recruit/ appoint the officers and other staff members of the Authority, as per rules and procedures laid down by the Government.
  • To render advice to the Central Government on changes/ revisions in the drug policy.
  • To render assistance to the Central Government in the parliamentary matters relating to the drug pricing.

 

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