Challenges in Ensuring Affordability of Essential Medicines
Patents often prevent Indian companies from producing affordable generics or biosimilars, leading to high drug prices.
Costly and time-consuming regulatory requirements for biosimilars hinder domestic production.
Government initiatives to import medicines can undermine domestic industry and disincentivize local production.
Foreign companies may enjoy monopolies due to patents and regulatory constraints, limiting competition.
Complex regulatory requirements and high costs of research and development add to production costs.
What is a Biosimilar?
A biosimilar is a biologic medical product highly similar to an already approved reference product (biologic drug).
They are designed to have similar safety, efficacy, and quality as the reference biologic but at a lower cost.
Biosimilars are subject to rigorous regulatory standards to ensure they are comparable to the original product.
Way Forward
Reevaluate recent measures such as import-focused strategies and duty waivers that could harm domestic production
Encourage local manufacturing through supportive policies and incentives, leveraging provisions in the Patents Act for compulsory and government-use licenses.
Modernize biosimilar approval processes by reducing redundant requirements, such as mandatory animal studies and extensive clinical trials.
Foster a competitive environment for essential medicines by reducing barriers to entry and supporting domestic companies.
Apply public interest provisions under the Patents Act to balance patent rights with public accessibility to affordable medicines.
COMMENTS