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Human Development

Generic Only Model : Concepts and Concerns

Generic Only Model : Concepts and Concerns

Relevance

GS 2 || Governance & Social Justice  || Human Development  ||Health

Issue?

  • There is an increased push by the government for generic drugs, for affordable health care.

What are generic drugs?

  • A generic drug is identical — or bio-equivalent — to a brand name drug in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use.
  • Although generic drugs are chemically identical to their branded counterparts, they are typically sold at substantial discounts from the branded price.

 Western Countries And India

  • In the West, brand names are given to researched and patented first-in-market innovator drugs.
  • After the expiry of patent period, other companies launch generics of the innovator drug with just the pharmaceutical salt name at a hugely discounted price.
  • So, the only difference between a brand name drug and its generic version is the price.

In India, where to get a drug license through political or bureaucratic connections by corrupt means is as easy as buying vegetables in the market.

  • Western Countries- Any medicine is made with lot research and a huge amount of money is invested into it.
  • They take patent for it .
  • These are branded drugs.
  • They are costly and they will recover costs from it.

When the patent of the particular company gets expired, then rest of the company copies the manufacturing process of the branded company giving rise to the Generic drug.

The Generic drug – drug is copied from another company, they only differ in price (they are cheap) no compromise is made on the quality needs

The only difference between a brand name drug and a generic is that brand name drugs are very expensive, while generics are far cheaper and are sold by just the pharmaceutical salt name. This is true for brand name drugs and generics in most developed countries.

India:

The issue in India is not about expensive brand name drugs versus cheaper generics, as in the West, but one of quality drugs versus suspect quality drugs. The active chemical substance is the same, the medical profile of generics is believed to be equivalent in performance.

  • The generic drug has the same Active Pharmaceutical Ingredient (API) as the original, but it may differ in characteristics such as manufacturing process, formulation excipients, color, taste, and packaging.

 Emphasis On Generics?

  • To cut down on out-of-pocket expenditure.
  • Cheap
  • In the Indian market, generics hold a whopping 75% share.
  • Pradhan Mantri Bhartiya Jan Aushadhi Pariyojana (PMBJP).
  • PMBJP stores have been set up to provide generic drugs, which are available at lesser prices.

Concerns?

  • India ranks third in the global pharma market (10% of  global sales)
  • India exports a lot of medicines because thry are cheap.
  • NSQ(Not Of Standard Quality)- 10 % of drugs that India export is apt  to its Quality.
  • Central Drugs Standard Control Organisation (CDSCO) –don’t have proper regulations to inspect generic medicines.
  • 67000 drugs are made in India from which only 15000-16000 are being inspected by regulating bodies.
  • Drugs were recalled
  • US Food and Drug Administration (US FDA) guidelines
  • Quality control mechanism

Branded generics are also generics with a brand name, plus the quality assurance from well-known companies like Cipla, Sun or Dr Reddy’s. Doctors have come to trust these companies and their brands over time.

Risk?

  • NCD burden
  • Low-quality drug delays- After the patient takes the generic drug, the amount of drug in the bloodstream is measured. If the levels of the drug in the bloodstream are the same as the levels found when the brand name drug is used, the generic drug will work the same
  • Substandard medicines-We should not compromise with the quality of the medicine.

Way  Forward

  • Global best standards, not lowest price of the medicine.
  • Medication should be affordable, superior-quality drugs.
  • The ‘generics-only model’ approach needs a critical reassessment.