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Concerns with Generic Medicine

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November 23, 2023

Why in news?

Patients in India rely on the advice of unqualified medical shop sellers instead of doctors when buying medicines.

What is the difference between generic and branded medicines?

About

Branded drugs

Generic drugs

Definition

They are also called as the “Innovator drugs” and are at first available in the market as new chemical entities

It is a pharmaceutical drug that contains the same chemical substance as a drug that was originally protected by chemical patents

Trade name

Sold under the manufacturer’s name

Not sold under the manufacturer’s name

Affordability

High Cost

Low cost

Patent protection

Produced by a company which holds the patent

Available at the market by the pharma companies only after the patent protection period expires

Animal and clinical study

Essential to perform tests

Not required

Features

The company formulates the chemical composition and establishes the dosage, strength, efficacy, administration etc.

The active ingredients, dosage, efficacy and administration are exactly same as that in branded drug

Competition

Little competition as patent protected

Competition is heavy due to price variation

What are the challenges associated with generic medicines?

  • Deciding authority- The doctors don’t have the freedom to choose the brand of generic medicine for the patient, only salesperson decides the brand.
  • Unethical practices- There is a corrupt link between pharmaceutical companies and doctors who can be influenced to give in to unethical marketing and promotional offers or kick-backs.
  • Counterfeit marketing - Big pharma companies focus on profit rather than quality and promote their costly propaganda against generic medicines.

 Hathi Committee in 1975 recommended for the gradual elimination of brand names.

  • Lack of accountability- There is no clarity about who will ensure the compliance to the quality standards of drugs.
  • NMC directive- National Medical Commission’s (NMC) notification asking registered medical practitioners to prescribe only generic medicines but was later suspended due to protests.
  • Poor quality- Unauthentic and sub-standard medicines stands at 4.5% and 3.4%, which will directly impact patients’ health.
  • Lack of essential medicine- Non essential medicines like vitamin tonics, cough syrup etc., are available in pharmacy but the rate of essential medicine is low.

generic-drugs

Steps taken by India to promote Generic Drugs

  • Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP)- It is implemented by Ministry of Chemicals and Fertilizers to provide quality generic medicines at affordable price.
  • Each batch of drug is tested at laboratories accredited by ‘National Accreditation Board for Testing and Calibration Laboratories (NABL).
  • Pharmaceuticals and Medical Devices Bureau of India- It procures medicines only from World Health Organization – Good Manufacturing Practices (WHO-GMP) certified suppliers.
  • Janaushadhi Sugam- It is a mobile application that provides information to public about location of Jan Aushadhi Kendra’s.
  • Free drug initiative- Implemented under National Health Mission (NHM), it aims to provide essential generic drugs free of cost in public health facilities.
  • National Pharmaceutical Pricing Authority – It fixes the ceiling price of Scheduled medicines specified in the Schedule-I (essential medicines) of the Drugs (Prices Control) Order, 2013.

What lies ahead?

  • Quality assurance- Government must ensure the quality of medicines produced, procured, and supplied through its Universal Health Coverage system as well as the private health-care network.
  • Periodic testing- The medicines that fail periodic quality test must be banned, with punitive action taken against manufactures.
  • Rules for generic drugs- Government should assure that the medicines in the markets are of standard quality, this would ensure confidence in doctors.
  • Proper monitoring- To ensure affordable medicines for all under Universal Health Care, free medicines and diagnostics are acceptable, but implementation needs to be monitored.
  • Promoting generic drugs nationally builds on the rich experience across states especially Rajasthan and Tamil Nadu who are pioneers in introducing generic drugs in public health system.

In India, annually, about 32 million people get pushed below poverty line because of expenditure on medical care.

 

References

  1. The Hindu- Branded, generic and missing ingredient of quality
  2. PIB- Sale of generic drugs in India
  3. PIB- Steps for promotion of generic medicines in India
  4. ET | Generic drugs
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