Insights into Editorial: Getting Narendra Modi’s generic medicines policy right
Generic medicines in India have received a new impetus with Prime Minister Modi himself advocating the usage of these medicines. Doctors will now be required to prescribe generic formulations of medicines, as opposed to specific brands.
What’s good about this move?
- 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—one of the largest suppliers of low-cost medicines in the world.
- With increasing pressure from the “Big Pharma” companies in developed countries, Indian generic manufacturers must now operate under a markedly restrictive intellectual property rights (IPR) regime. The new policy can ensure that—at least in the Indian market—generic manufacturers retain an advantage. Big Pharma’s access to Indian consumers will have to be routed through generic companies using channels such as voluntary licensing.
- Low-cost medicines, apart from their attribute as a commercial commodity, have far-reaching implications on public health and international human rights. India has unambiguously subscribed to the pro-public health argument, and has articulated its position several times at home and in international forums.
However, there are three fundamental areas of concern.
- The first relates to the efficacy of Indian-made drugs. Oftentimes, such drugs have been found to contain less than the required amount of active pharmaceutical ingredient (API), rendering them ineffective.
- Closely linked to the issue of efficacy is the lack of data integrity. The poorly managed documentation practices of Indian generic firms featured as the primary criticism flagged by foreign regulatory authorities. The lack of reliable and complete data on the test results of specific drug batches, along with inconsistencies in the records presented, meant that inspection and verification of drug quality was extremely difficult.
- Another aspect relates to the hygiene standards of the manufacturing plants. Individuals suffering from illness are especially susceptible to infections, and inspections of generic drug plants reveal pest infestations and dilapidated infrastructure.
The push towards generics is lauded by many stakeholders. In a global economic environment that is turning increasingly hostile to generic drug production, this is a bold move—indicative of the government’s categorical support for one of its key industries.
While the push for a generics-only policy is a step in the right direction, it is important to assess and ensure that Indian generic companies are competent enough to take on the task before institutionalizing such a policy. Also, the policy must move beyond rhetoric—for in a sector such as health, faulty policy design will directly affect the country’s mortality statistics.