Why in the News?

The government has introduced two import-based initiatives to meet domestic needs, which could potentially dampen the growth of the domestic industry.
New medicines are generally under patent protection, preventing Indian companies from producing affordable generics/biosimilars.

Impact of two initiatives on Domestic Industry:

Global Tendering for 120 Medicines: The Department of Expenditure (DoE) allowed the Ministry of Health to buy 120 medicines, including popular anti-diabetes and anti-cancer drugs, through global tenders for government programs. This decision, which specifies certain brands for over 40 of these medicines, could increase the monopoly of foreign companies in India.
Customs Duty Removal on Cancer Medicines: The 2024-25 Union Budget proposed removing the 10-12% customs duty on three cancer medicines marketed by AstraZeneca. While intended to reduce prices, this measure is unlikely to significantly lower costs and may instead increase reliance on imports, further disadvantaging domestic producers.

India is a leading manufacturer of vaccines, accounting for 60% of global production.
India supplies 70% of vaccines used by the WHO.
India is a major exporter of generic drugs, accounting for 20% of global exports.
The industry is expected to grow to over $130 billion by 2030.

Biosimilar guidelines in India are regulatory frameworks established by the Central Drugs Standard Control Organization (CDSCO) and the Department of Biotechnology (DBT) to govern the development, approval, and marketing of biosimilars.
Biosimilars are biologic medical products that are highly similar to an already approved original biologic (known as the reference product), with no clinically meaningful differences in terms of safety, purity, and potency.

Significant Market Size: The biosimilar market in India is valued at approximately $2.2 billion, and it is projected to reach $40 billion by 2030. This growth is driven by the expiration of patents for several key biologics, which opens the door for biosimilar development.
Product Approvals: As of now, over 70 biosimilars have been approved in India, covering a range of therapeutic areas, including oncology, diabetes, and autoimmune diseases. Notable examples include:
- Adalimumab (for rheumatoid arthritis)
- Trastuzumab (for breast cancer)
- Filgrastim (for neutropenia)
- Insulin glargine (for diabetes)

Obsolete and Resource-Intensive:
- India’s biosimilar guidelines are outdated, requiring mandatory animal studies, which are no longer necessary in developed countries like the U.S. and EU with stringent regulatory standards.
- The guidelines also mandate clinical trials, while WHO and U.K. guidelines treat clinical trials as an exception rather than a rule.
Barrier for Domestic Producers:
- The stringent requirements for animal studies and mandatory clinical trials create significant barriers for Indian producers, making it difficult for them to compete with their global counterparts.
Impact on Patient Access:
- According to the International Generic and Biosimilar Medicines Association, eliminating these duplicative requirements could lead to significant savings in time and resources, ultimately improving patient access to affordable biosimilars.

Update Regulatory Guidelines: Modernize India’s biosimilar guidelines by removing unnecessary requirements like mandatory animal studies and clinical trials, aligning them with global standards to reduce barriers for domestic producers.
Support Local Production: Utilize provisions in the Patents Act to promote domestic manufacturing of affordable medicines, reducing reliance on imports and strengthening the local pharmaceutical industry.