India’s biopharmaceutical and biosimilar industry

Source: The post India’s biopharmaceutical and biosimilar industry has been created, based on the article “Tweaks in drug formulations to extend copyrights is a public health challenge” published in “Indian Express” on 28th October 2024

UPSC Syllabus Topic: GS Paper 3- changes in industrial policy and their effects on industrial growth. And GS2-Governance– Government policies and interventions for development in various sectors and issues arising out of their design and implementation.

Context: The article discusses India’s growing biopharmaceutical industry and the challenges of patent evergreening, which keeps drug prices high. It highlights efforts like the National Biopharma Mission to boost biosimilar production and calls for stronger patent opposition.

For detailed information on the rapid growth of the biopharmaceutical industry read this article here

What is the current status of India’s biopharmaceutical industry?

1. India’s biopharmaceutical industry is valued at $60 billion, ranking as one of the fastest-growing globally.
2. The country has improved in innovation, moving from 81st to 39th in the Global Innovation Index since 2015.
3. India is a leader in biosimilars, with 98 approved products, including those sold in the US; it was the first to approve a Hepatitis B biosimilar.

What are biopharmaceuticals and biosimilars?

1. Biopharmaceuticals are medicines derived from living cells, such as yeast or bacteria, unlike conventional drugs made from chemicals.
2. They are crucial in treating chronic illnesses like cancer, diabetes, cardiovascular disease, and autoimmune diseases.
3. Biosimilars are medicines made from living cells, similar to original biologic drugs. They offer the same safety and effectiveness as the original biologic.
4. India’s biosimilars market was valued at $349 million in 2022 and is projected to grow by 25.2% annually, reaching $2,108 million by 2030.

How is the Global Landscape on Biosimilar Patents?

1. In the US, 74% of new patents are associated with existing drugs, extending their monopoly period. Nearly 80% of top-selling drugs are protected by extended patents.
   2. In Europe, the approval process for biosimilars is simpler, especially in countries like Germany and the UK, leading to cost savings and wider access to medicines.

What incentives have been implemented to support India’s biopharmaceutical industry?

1. National Biopharma Mission (NBM): The $250 million NBM, co-funded by the World Bank, supports 150 organizations and 300 MSMEs. It has established 21 research facilities crucial for COVID-19 vaccine trials, boosting India’s biopharma industry.
2. Make in India Initiative: This initiative supports domestic manufacturing, including the biopharmaceutical sector.
3. Biopharma Product Development: NBM funding led to 18 successful products, benefiting India’s healthcare goals.

What are the challenges facing India’s biopharmaceutical industry?

1. Patent Evergreening: Multinational companies extend monopoly by making minor changes to drugs nearing patent expiry. Roche, for example, extended the patent exclusivity of trastuzumab (a biologic used to treat breast cancer) by introducing a subcutaneous version of the drug just as the original patent was nearing its expiration.
2. Market Access Limitations: India holds only 3% of the global biosimilars market due to barriers like patent extensions, limiting affordable options for patients.
3. Delayed Biosimilar Adoption: Unlike the EU, where biosimilars are widely accepted, Indian regulations need enhancement for quicker approval, as seen in Europe, where countries like Germany and the UK save costs with simpler approvals.
4. Regulatory Challenges: India’s robust patent laws, like Section 3(d) of the Patents Act, aim to curb evergreening, yet about 72% of granted pharmaceutical patents in India are for minor or secondary innovations, highlighting the need for more stringent patent scrutiny.

For detailed information on INDIAN PHARMACEUTICAL SECTOR CHALLENGES AND REFORMS read this article here

Question for practice:

Evaluate the current status, growth potential, and challenges facing India’s biopharmaceutical industry, particularly in the area of biosimilars.