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Indian pharmaceutical industry UPSC NOTE

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  Challenges in Ensuring Affordability of Essential Medicines Patents often prevent Indian companies from producing affordable generics or ...

 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.

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Learnerz IAS | Concept oriented UPSC Classes in Malayalam: Indian pharmaceutical industry UPSC NOTE
Indian pharmaceutical industry UPSC NOTE
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Learnerz IAS | Concept oriented UPSC Classes in Malayalam
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