Rationale: It is a well-known fact that branded medicines are sold at significantly higher prices in India. Given the widespread poverty across the country, making available reasonably priced quality medicines in the market would benefit everyone, especially the poor and the disadvantaged.

By: Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers

Implementation agency: Bureau of Pharma PSUs of India (BPPI); the State Governments are required to provide space in Government Hospital premises or any other suitable locations for the running of the Jan Aushadhi Stores (JAS)

Objective: Making quality medicines available at affordable prices for all, particularly the poor and disadvantaged, through exclusive outlets “Jan Aushadhi Medical Store”, so as to reduce out of pocket expenses in healthcare.

Pradhan Mantri Bhartiya Jan Aushadhi Kendra (PMBJK) has been set up to provide generic drugs, which are available at lesser prices but are equivalent in quality and efficacy as expensive branded drugs.

Mission

  • Create awareness among the public regarding generic medicines.
  • Create demand for generic medicines through medical practitioners
  • Create awareness through education and awareness program that high price need not be synonymous with high quality
  • Provide all the commonly used generic medicines covering all the therapeutic groups
  • Provide all the related health care products too under the scheme

What exactly is the difference between a generic drug and brand- name drug?

When a company develops a new drug — often after years of research — it applies for a patent, which prohibits anyone else from making the drug for a fixed period. To recover the cost of research and development, companies usually price their brand- name drugs on the higher side. Once the patent expires, other manufacturers duplicate and market their own versions of the drug. Since the manufacture of these generic drugs does not involve a repeat of the extensive clinical trials to prove their safety and efficacy, it costs less to develop them. Generic drugs are, therefore, cheaper.

However, because the compounds in the generic versions have the same molecular structure as the brand-name version, their quality is essentially the same. The generic drug has the same “active ingredient” as the brand-name drug. This ingredient is the one that cures the patient; and other, “inert ingredients”, which give the drug its color, shape or taste, vary from the brand-name drug to the generics.

  • The prices of generic medicines are much cheaper than their branded equivalent.
  • The generic drug does not have to undergo a complete clinical trial to be proved equivalent, the bioequivalence test is much cheaper than clinical trials making generic drugs cheaper.
  • The government’s move assumes significance as medicines account for 70-75% of a household’s out of pocket expenditure on health
  • The move will result in affordable access to quality medicines which is a part of free universal access to healthcare services.
  • India being a world leader in generics, the dependency on imports of patent drugs will reduce improving our trade of balance.

The Way Forward:

Support of the State Government: The scheme is riding on the co-operation of the state governments. The central government is responsible for the supply of quality medicines, while the state governments or government-appointed NGOs were to run the shops on a not-for-profit basis.

Strong Regulation: A strong regulatory structure should be put in place to both certify and monitor drug testing and enforce the compliance with GMP (Good Manufacturing Practice). There is also a need to bring a legal framework to ensure “quality” in generic drug testing.

Proper Legal Mechanism: If the government wants to make the prescription of generics compulsory, it needs to put in place a legal mechanism to guarantee that all generics are bioequivalent to the innovator product by making bioequivalence testing compulsory (Bioequivalent generic drugs are therapeutically equal to the innovator drug. Once bioequivalence is established, a generic drug is legally certified to be of the same quality to replace the innovator product and can, therefore, be interchanged for the innovator product).

Database of drug Relators: Need to use IT tools to network all 36 drug regulators into one integrated national database which can then be accessed by every citizen over a smartphone.

Proper Tagging: All products should be tagged with a unique RFID, barcode or such similar identification to ensure traceability from manufacture to consumption. Generics should be labeled and sold as such in order to prevent a brand to brand substitution rather than a brand to generic substitution at the retail level.

Cap the Price: Capping the maximum sale price of the generic taking into account the cost of making the drug and distribution and retail margins as branded generics can be as costly as patent drugs.

Categories: Opinion