Generic drugs are everywhere – and that’s a problem

Source: This post has been created based on the article “” published in The Indian Express on 12^th October 2023.

UPSC Syllabus Topic: GS Paper 2 Social Justice — Issues relating to development and management of Social Sector/Services relating to Health.

News: This article discusses the issue of unbranded generic drugs and the related problem of substandard and spurious drugs. It also highlights the need for Good Manufacturing Practices in the pharmaceutical sector to tackle these challenges.

What are some allegations raised with respect to pharmaceutical companies?

Manipulation of trials, hiding of side effects, establishing monopolies through patents and other means, bribing doctors and harming patients.

Asymmetric information with respect to pharmaceuticals leads to uninformed choice, and health-care costs for patients are also unnecessarily increased.

However, there is only a small amount of truth in all these allegations.

The real issue is the cost of drugs, since medicines account for a large share of costs, especially if it is out-of-pocket.

Unregulated markets where tax evasion, spurious and substandard drugs, non-adherence to temperature and lack of other quality controls takes place, are also a cause of concern.

What are the different types of medicine?

Broadly, medicines are of three types:

(1) Still on patent and therefore, a brand;

(2) Off patent and generic, but nonetheless produced by a reputed company, with a brand;

(3) Off-patent, generic and unbranded.

For a particular course of treatment, there may be a choice and substitution between (1), (2) and (3), with variations in side effects as well as prices.

What is the status of pharmaceutical manufacturing?

Out of the 8,500 drug-manufacturing MSMEs, only 2,000 are GMP-compliant (GMP = Good Manufacturing Practices).

Enforcement of the Drugs and Cosmetics Act, and also the lack of enforcement, increases the problem.

Mashelkar Committee 2003 on drug regulatory issues had stated that, “the extent of substandard drugs varied from 8-10% and spurious drugs (fake, counterfeit drugs) are less than half a percent.”

What are the issues with unbranded generic medicine?

Additional health costs of substandard generic drugs not taken into account: Unbranded generic medicines are being pushed through Jan Aushadi outlets due to their prices being cheaper. However, there is a health cost of substandard drugs which is not being taken into account.

Undue Influence by big pharma companies: Pharma companies may lobby and influence pharmacies which will sell these generic medicines, just like they do with doctors.

A lack of information about the effects of unbranded generic medicines hampers patients’ freedom of choice.