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What's the article about?
- It talks about the issue of generic vs branded medicines.
Relevance:
- GS2: Issues Relating to Development and Management of Social Sector/Services relating to Health, Education, Human Resources;
- Prelims
Context:
- Recently, the Director General of Health Services (DGHS) issued an order directing that doctors at central government hospitals, Central Government Health Scheme (CGHS) wellness centres, and polyclinics prescribe only generic medicines instead of branded drugs.
- In this context, let us understand why doctors do not prefer generic drugs.
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What are generic drugs?
- The brand producing a new molecule gets a patent to be able to have selling rights. Once a drug loses its patent protection, it can then be produced by several other drug manufacturers and is called a ‘generic’.
- A generic drug is defined as a drug product that is comparable to a brand/reference-listed drug product in dosage, strength, route of administration, quality and performance characteristics and intended use.
- Branded generics are those that are given a unique name by their marketers to enable doctors and patients to identify a product they can trust from the ocean of numerous alternatives.
Analysis:
- Such directions are given now and then by the government to the doctors. But still doctors seem unwilling to prescribe generic medicines over branded drugs.
- There is widespread perception that doctors prefer branded drugs over generic due to associated monetary benefits (such as “cut” from pharma companies). But this is a narrow understanding of the underlying issue.
Following are key reasons for doctors preference to the branded drugs over generic medicines:
- Quality of generic medicines:
- Many Indian doctors in both the public and private sector simply do not trust the quality of all generic medicines in the Indian market.
- This is because, India has lagged behind countries like the U.S. in creating the appropriate legal and scientific standards that provide guarantees to doctors on the interchangeability of generic medicines with each other and the innovator drug.
- Question on “bioequivalence” of generic drugs:
- A generic drug must have to pass the test of being bio-equivalent.
- Two products are considered to be bioequivalent when they are equal in the rate and extent to which the active pharmaceutical ingredient (API) becomes available at the site(s) of drug action.
- For this a generic drug is given to the human volunteers in order to measure the rate at which the drug is bioavailable; i.e. the rate at which the drug dissolves in the bloodstream.
- If generic drugs pass this test, then it is considered therapeutically interchangeable with the innovator drug.
- India mandated such bio-equivalence testing only in 2017. Even then, the regulations were vague. This means that a vast majority of drugs in the Indian market have never been tested for bio-equivalence. Thus doctors simply do not trust them.
- Issue of stability testing:
- A drug must remain intact in a variety of environment conditions. The key challenge to manufacturing any drug is to ensure that it remains stable through a stressed supply chain in differing conditions of heat and humidity. This is ensured with help of stability testing.
- Until 2018 it was not mandatory for generic drugs to clear stability tests, thus raising questions over their safety and efficacy.
- Moreover the 2018 guidelines did not apply retrospectively to generic drugs approved prior to 2018. This means that many generic medicines in the Indian market have not been subjected to mandatory stability testing.
Way Forward:
- Given these issues related to the quality of generic drugs, it is not appropriate for the DGHS to force doctors to prescribe drugs by generic names. Rather, the DGHS must work towards resolving the genuine concerns being raised by doctors.
- A starting point would be to ask for regulations which require pharma companies to identify on their packaging whether a drug has been tested for bio-equivalence and stability as required by the law.
