What is the issue?
- There is an increased push by the government for generic drugs, for affordable healthcare.
- But the concerns with quality of the generics call for a relook on this 'generic-only model'.
What are generics?
- A generic drug is a copy of drug medication created to be the same as an already marketed brand-name drug.
- It equals in dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use.
- Generics do not involve repetition of extensive clinical trials over the years, unlike brands that undergo extensive R&D procedure.
- Hence, generics' manufacturing cost is less, and so are their prices.
Why is the emphasis on generics?
- The government, to cut down on out-of-pocket expenditure and ensure affordable healthcare, is relying on a generics-only model.
- In the Indian market, generics hold a whopping 75% share.
- The push for generics witnessed a boom under Pradhan Mantri Bhartiya Jan Aushadhi Pariyojana (PMBJP).
- It is a campaign launched by the Department of Pharmaceuticals to provide quality medicines at affordable prices to the masses.
- PMBJP stores have been set up to provide generic drugs, which are available at lesser prices.
What are the concerns?
- India ranks third in the global pharma market (10% in global sales) but the domestic scenario is less encouraging.
- A 2016 study on Spurious and Not of Standard Quality (NSQ) medicines in the supply chain in India hints at this.
- More than 10% samples were declared NSQ in the supply chain, of medicines procured by government agencies, compared to the all-India average of 4%.
- Central Drugs Standard Control Organisation (CDSCO) report shows that a range of commonly consumed generic drugs fall short of standard quality-control criteria.
- In 2017, five drugs were recalled from Jan Aushadhi stores over quality lapses.
- Another six drugs were rolled back in the first four months of 2018.
- Most of India’s generic drugs manufacturers do not follow US Food and Drug Administration (US FDA) guidelines for domestic distribution.
- India has more than 67,000 drug formulations.
- But the quality control mechanism of all the Central Drugs Testing Laboratories can ascertain the quality of only 15,753 drugs annually.
- But branded generics follow regulatory mechanisms like US FDA and WHO Good Manufacturing Practices, making them more reliable.
What is the inherent risk?
- Come 2020, the NCD burden will be responsible for 73% of deaths and 60% of disease burden in India.
- A low-quality drug delays recovery time, weakens the immune system by a longer duration of dosages, and invites comorbidities.
- Substandard medicines may promise affordable healthcare in the present, but in the future results could be catastrophic.
- Thus, relying on generics alone can be counter-productive in the mission to make India disease-free.
What does it call for?
- Medicine procurement and distribution should be driven by global best standards, not lowest price.
- For the goal of universal health coverage by making medication affordable, superior-quality drugs are a prerequisite.
- The ‘generics-only model’ approach needs a critical reassessment for dealing with India’s disease burden.
Source: Financial Express