The US Biosecure Act, passed in Sept 2024, is highly beneficial for Indian API manufacturers for the US market, as it bans CDMOs. This act restricts ‘biotechnology equipment or service’ from ‘biotechnology companies of concern’ or CDMOs. This implies companies under China’s contract development and manufacturing organisations, considered a potential risk for the US. Hence, India, the third-largest API producer in the world, is at an advantage, especially for those with US-FDA and E-GMP certificates.
Furthermore, the Indian Government is supporting with Production-Linked Incentives to API manufacturers for strong R&D, consistent supply, and certification procedures. Jatan Exports is the merchant exporter of Indian API, selling ONLY India-made materials to the USA, LATAM, and European countries. We simplify the purchase requisition of USA buyers by offering DMF and US-FDA-certified API manufactured in India from numerous manufacturers. This helps them to consolidate documents, different price offers, and material specifications on the finger tip. Besides, our comprehensive service covers customs clearance, freight in any Incoterm, and documentation in any international port.
Key factors redirecting API sourcing to India
The main factors that redirect API sourcing to India as Chinese API alternative suppliers are as follows:
- Restrictions on China Make – The US wants to establish a biosimilar ecosystem other than China, as adversary-linked companies are creating a gap and threat in the supply chain of API.
- Compliance – Indian companies possess a full set of compliance documents and also provide price benefits to USA buyers.
- “China + 1 mandate” – It implies not to over-rely on China or invest heavily in them and keep another nation active for risk mitigation or resilience in the supply chain of pharma raw materials and equipment.
How the Biosecure Pharma Act impacts API Buyers in FY26?
“India’s pharmaceutical exports surged to a record $31.11 billion in FY2026, up from $15.44 billion in FY2014,” as quoted by Pharmexcil. Decoupling from China and the Biosecure Pharma Act impact will secure immense growth of Indian manufacturers; however, international API buyers will also benefit in FY26 from this scheme. As a structural catalyst, the Indian Government is giving 5-20% incentives on tools, infrastructure, electricity, and the SPI scheme. This has boosted this segment for the benefit of buyers in FY26.
The Department of Pharmaceuticals Annual Report says 600 US-FDA and 1400+ WHO-GMP certified plants are facilitated for US API buyers. This will ensure the supply chain of API from India to the USA, Latam, and 200 countries.
Why does India remain the world’s most reliable API sourcing geography?
India remains the world’s most reliable API sourcing geography due to USFDA-approved API manufacturers in India covering:
- 57% API in the pre-qualified list mentioned in the World Trade Organization.
- Indian API manufacturers make 29% of essential and 38% of non-essential API.
- Government funding to reduce upstream reliance on China
- Skilled labour with low cost
- Wide availability of land and power for uninterrupted production capacity
Challenges of Indian API manufacturers due to the Biosecure Act
Besides tailwinds, there are two major challenges among many others impacted due to the Biosecure Act. India has a lower supply of raw starting materials and intermediates to make APIs due to domestic upstream capacity. Scaling up the technology transfer and facilities certifications with audit and safety care are non-negotiable.
Indian Government incentives for pharmaceutical companies have leveraged to take maximum benefit of the US Biosecure Act for upscaling Indian export CAGR to far higher digits. Jatan Exports is presently operating as a successful API exporter of India with 3000+ certified and compliant products. Our sources are approved for registration and export in the US market, as we provide all regulatory documents at no extra cost. Our stock is ready and has the capacity to supply on a long term basis by mitigating risk factors of production and batch specifications establishment. For more information, documents, and product inquiries, connect with us now.
Leave a Reply