International life sciences regulations: How CROs, CMOs, and CDMOs are primed for advantage

Bioeconomy is a critical growth multiplier of the Indian economy – according to the India BioEconomy Report 2022, BioEconomy accounts for nearly 2.6 per cent of India’s GDP in 2021 (1). Courtesy of contract research organisations (CROs), contract manufacturing organisations (CMOs), and contract development and manufacturing organisations (CDMOs), India’s life sciences sector is rising steadily. The CRO sector in India, growing at a compound annual growth rate (CAGR) of 10.75 per cent, is projected to reach $2.5 billion by 2030 (2). Similarly, India’s pharmaceutical contract manufacturing market is expected to increase at a CAGR of 14.67 per cent, hitting $44.63 billion by 2029 (3). 

Indian CROs have evolved from being low-cost service providers to key players in advanced drug discovery, clinical development, and regulatory affairs, particularly in Western markets. This shift is driven by India’s cost advantages, a skilled and cost-effective workforce, and a regulatory framework that provides strong support. The cost to conduct clinical trials in India is estimated to be 40 – 70 per cent lower compared to the US or the EU (4), making the country a magnet for research and clinical development. Manufacturing costs in India are also 30 – 35 per cent lower than those in the US and Europe (5), further sweetening the deal for global pharmaceutical companies. 

However, understanding the complex global regulatory environment is essential for Indian CROs, CMOs, and CDMOs to take full advantage of these opportunities. While challenges exist, compliance brings many benefits. Adhering to global standards ensures the safety and effectiveness of pharma products and medical devices and opens doors to enhanced market access, sustaining the growth of Indian life sciences companies.

Compliance as the growth driver 

The US Biosecure Act, aimed at curbing US dependence on Chinese biotechnology, opens new avenues for Indian CDMOs. With their focus on delivering reliable and varied manufacturing services, these firms stand ready to address the shortfall restricted Chinese players created.6 In response, Enzene Life Sciences is expanding its capabilities with its EnzeneX platform, which enhances productivity and reduces costs. This strategic alignment with the Biosecure Act’s objectives makes Enzene an attractive partner for Western companies seeking dependable alternatives outside China (7).

Compliance with Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP) standards is crucial for accessing regulated markets like the US and EU. Following these standards can help Indian firms emphasise quality and ethical practices, build trust, and establish long-term partnerships to ensure continuous investments in infrastructure and training (8). The renewal of Good Manufacturing Practice (GMP) certificates for Biocon Biologics Limited’s facilities in India and Malaysia, issued by the Health Products Regulatory Authority (HPRA) on behalf of the European Medical Agency (EMA), underlines the importance of meeting global standards to enter new markets (9).

The European Medicines Agency (EMA) operates within a regulatory framework that includes key regulations such as the Medicinal Products Regulation, the Medical Devices Regulation, and Good Manufacturing Practice (GMP) (10). These regulations ensure the safety, efficacy, and quality of medicines and medical devices within the EU. Biocon Biologics gained EMA approval to manufacture biosimilar Bevacizumab at its advanced facility in Bengaluru, enhancing its credibility internationally.

International Council for Harmonisation – Good Clinical Practice (ICH-GCP) is another significant global regulatory standard that ensures ethical, high-quality clinical trials to protect patient rights and enhance data integrity (11). For example, Asiatic Clinical Research in Bengaluru adheres to ICH-GCP by providing phase II-IV support with trained sites across India. Similarly, CliniRx in New Delhi leverages ICH-GCP to offer comprehensive services for Phase II-IV trials globally, benefiting from its affiliation with the JK Organisation for financial stability and global reach (12).

In life sciences, ISO 13485 and ISO 9001 certifications confirm the safety and quality of product manufacturing. ISO 13485 focuses on the safety and efficacy of medical devices, which are essential for EU compliance, while ISO 9001 emphasises customer satisfaction. ABX-CRO, with ISO 9001:2015 and ISO 13485:2016, exemplifies how these standards can be integrated (13). Telangana-based Sai Life Sciences, certified in ISO 14001 and ISO 45001, adheres to environmental management and occupational safety protocols (14).

The EU AI Act, effective from August 1, 2024, introduces a risk-based framework for AI systems, imposing stringent requirements on high-risk categories, including medical devices (15). This regulation presents considerable opportunities for Indian life sciences companies. For instance, Sigtuple, which specialises in AI-aided medical diagnostics, is adopting comprehensive risk management practices and complying with pre-marketing testing mandates. This alignment with the Act’s requirements supports Sigtuple’s market entry into the EU and boosts its global reputation and competitiveness (16).

Plenty to consider and execute 

Remaining competitive will require Indian CROs, CMOs, and CDMOs to continuously invest in quality management and swiftly adapt to evolving global regulations. According to the report “A Bold Future for Life Sciences Regulations: Predictions 2025” by Deloitte (17), embracing advanced technologies such as AI, blockchain, and real-world evidence (RWE)— which could reduce time to market by up to 24 per cent— will be crucial in the near future. As global regulations become more harmonised and compliance is simplified, Indian firms should strategically expand into new markets, leveraging a deep understanding of regional regulations and forming local partnerships. Proactively incorporating these innovations and responding to regulatory shifts will empower life sciences players in India to lead in the global market and turn regulatory compliance into a strategic asset for innovation and growth.

References 

1. 1658318307_India_Bioeconomy_Report_2022.pdf (birac.nic.in)
2. https://pharmaceuticals.gov.in/sites/default/files/CRO%20Market%20Report_High%20Resolution.pdf
3. https://www.mordorintelligence.com/industry-reports/indiacontract-manufacturing-organization-market
4. https://www.georgeclinical.com/global-coverage/india-cro
5.  https://www.ibef.org/industry/ pharmaceutical-india
6. https://www.businesstoday.in/industry/pharma/story/why-indian-cros-and-cdmos-stand-togain-from-the-us-biosecure-act437334-2024-07-16
7. https://www.biopharma-reporter.com/Article/2024/06/06/Three-Indian-CDMOs-ready-to-seizethe-BIOSECURE-Act-opportunity#:~:text=Enzene%E2%80%8B,I ndian%20CDMO%20market%20to %20thrive.
8. https://www.seclifesciences.com/blog/the-golden-trio-of-qualitygmp-gcp-and-glp-the-pathway-tosuccess-and-compliance/
9. https://www.biocon.com/ema-approves-biocon-biologics-new-mabsfacility-in-india-and-renews-gmpcertifications-for-india-and-malaysia-sites/
10. https://www.ema.europa.eu/en/ homepage
11. https://pharmaphorum.com/rd/ unravelling-impact-ich-e6r3-goodclinical-practice
12. https://www.pharmatutor.org/articles/list-of-clinical-research-organizations-in-india
13. https://abx-cro.com/
14. https://www.sailife.com/sai-lifesciences-receives-iso-140012015-and-iso-450012018-certification/
15. https://www.ibanet.org/impacteuropean-union-artificial-intelligence-act
16. https://economictimes.indiatimes.com/tech/technology/indianai-firms-may-face-extra-costs-aseus-ai-act-kicks-in/articleshow/110572036.cms?from =mdr
17. https://www2.deloitte.com/content/dam/Deloitte/global/Documents/Life-Sciences-HealthCare/gx-life-sciences-regulationpredictions-2025.pdf