Polity & Governance Prelims cum Mains

Getting the generic drug plan right

The topic

  • Generics and branded generics

 

Background

  • In 2016, the MCI has amended the regulation mandating doctors to prescribe using the generic name to ensure a rational prescription and use of drugs.
  • In March 2017, the Health Ministry had initiated a discussion on promoting generic drugs late and the proposals include asking manufacturers to ensure labels that carry generic names of medicines in a font size much larger than the brand name.
  • In April, 2017, the Prime Minister’s statement on getting doctors to prescribe medicines using their generic names have put the issue of generic medicines on the centre stage once again.

 

About generics

  • 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.
  • The US Food and Drug Administration defines a generic drug as identical or bio-equivalent to a brand name drug in dosage form, safety, etc.
  • These medicines are usually much less expensive than the original branded medicine.
  • And the explanation for this is that it factors in the cost of research to bring out an innovative medicine.

 

Difference between generics and branded generics

  • 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.

 

Generics in India

  • In India, many doctors rely on branded drugs due to the goodwill and trust built over the years as they ensure quality, efficacy and accessibility.
  • India is largely a generic drugs market and yet companies differentiate their products through brandnames that command higher prices.
  • Generic medicines in India have received a new impetus with Prime Minister himself advocating the usage of these medicines.
  • The Prime Minister has announced that prescription of medicines by their generic names will be mandatory.
  • The generic drug manufacturing industry of India one of the largest suppliers of low-cost medicines in the world.

 

Advantages of generics

  • This is expected to bring down drug prices and expand access to affordable health solutions.
  • As per the latest National Sample Survey Office survey on healthcare, in 2014, medicines emerged as a principal component of total health expenses—72% in rural areas and 68% in urban areas.
  • For a country with one of the highest per capita out-of-pocket expenditures on health, even a modest drop in drug prices will free hundreds of households from the widespread phenomenon of a medical poverty trap.
  • In addition to the social benefits, the generics-only policy also makes economic sense.
  • By promoting generic drug consumption, the government safeguards the health of its generic drug manufacturing industry.

 

Problems with generics in India

  • The government’s decision to ask doctors to prescribe a generic name has made things complicated.
  • The doctors’ still doesn’t know that about branded generics and how it is different from generics.
  • For them, generics are the medications available in Jan Aushadhi centres.
  • Most of them prescribe medications under this category all the time, yet are still unaware of the third category called branded generics.
  • Though efforts have been made to draw the government’s attention to the substandard quality of some generic drugs floating across the country there is still no clarity on the definitions of all three categories.
  • The confusion is not just limited to laypersons and is prevalent among doctors too, which is worrying.
  • The key concern is that prescribing generic names could shift the “decision making” from the doctor to the retailer or chemist who may not understand the scientific rationale or have the best interest of the patient in mind.
  • There are some chemists who will look to have a higher margin.
  • This is often because chemists do not have a way to know about the differences in quality as patients do not come back and inform them about their recovery.
  • Current regulations allow doctors to prescribe branded as well as generic drugs, but one needs to understand that generic drugs can also be produced by brands (branded generic).
  • Hence the latest regulation needs a lot more clarity before it is rolled out.

 

Way forward

  • There is a need to have in place stringent criteria for government agencies to ensure that there is no difference in the dose, efficacy, potency and side-effects between generics and the branded ones.
  • The government should ensure that all pharmacies have qualified pharmacists and that basic quality is maintained for all generics produced in India.
  • In short, there should be a sort of star-rating for quality certification, helping people to understand the quality of the generic.
  • The government’s intention to promote generics will reach its goal only if these three important factors (clarity in definition, safe quality and standardised quality certifications along with qualification of pharmacists) are considered.

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