[op-ed snap] How to free Indians from the medical poverty trapop-ed snap

Note4students

Mains Paper 2: Governance | Issues relating to development & management of Social Sector/Services relating to Health, Education, Human Resources.

From UPSC perspective, the following things are important:

Prelims level: Generic medicines, bioequivalence

Mains level: Issues related to health sector and way forward

Context

Dichotomy in medicine sector

1. India is the largest supplier of generic drugs in the world
2. Indian pharmaceutical companies have famously succeeded in pushing down the cost of medication in many countries across the world
3. Yet, too many Indian citizens do not get access to medicines owing to high costs

Problems

1. Thin insurance cover that leads to most patients paying for medical expenses out of their pockets after they have been diagnosed with an ailment
2. Medicines are a major component of total health expenses—72% in rural areas and 68% in urban areas
3. Healthcare costs pushed 60 million Indians below the poverty line in 2011

Government’s role

1. The government is aware of the problem, which is why it has been fixing the prices of “essential medicines” for some time, and even medical devices such as stents and knee replacement caps from this year
2.  But the solution of the government right now—price control—is suboptimal

Generic medicines

1. Generic medicines are affordable versions of the drug, introduced after a company loses patent over a medicine
2. These medicines are sold either by their salt-name or by a brand (called branded generics)
3. For example, Crocin is a branded generic whose active ingredient is paracetamol

What can be done?

1. Cheaper generics are one of the important factors for reducing healthcare cost
2. The practice of generic substitution is strongly supported by health authorities in many developed countries where bioequivalence tests are mandatory

Challenges before generic medicines can become mainstream

1. The poor regulatory regime has dented perceptions about the quality of generic drugs
2. Since generic products don’t advertise—and save costs that way—the good-quality manufacturers are not able to compete with shoddy manufacturers on cost
3. The incentive to cut costs increases as massive government contracts are allocated to the lowest bidder

Back2Basics

Bioequivalence

1. In most countries, the generic drug manufacturers have to prove “bio-equivalence”, i.e. the generic medicine works the same way, to the same extent and for the same purpose, as the originally patented drug
2. The regulations in India until April 2017, required bioequivalence testing only during the first four years of a drug becoming available for generic production
3. After four years, manufacturers only need permission from the state licensing authorities that don’t demand the data
4. The law has changed to require bioequivalence tests for some classes of generic medicines, but its coverage is not universal