How India Exports Collagen to the World

Collagen-based products are utilized in various medical applications, including wound care and orthopedic treatments. According to the FDA's Orange Book, as of March 2026, there are no approved Abbreviated New Drug Applications (ANDAs) specifically for collagen products. This indicates a limited presence of generic collagen-based drugs in the U.S. market. The primary regulatory pathway for collagen products involves the submission of a New Drug Application (NDA) or a Biologics License Application (BLA), depending on the product's classification. Given that the United States accounts for 17.2% of India's collagen exports, Indian manufacturers must ensure compliance with FDA regulations to maintain and expand their market share.

In the European Union, the European Medicines Agency (EMA) oversees the approval of medicinal products, including those containing collagen. Manufacturers are required to obtain a marketing authorization, which necessitates adherence to Good Manufacturing Practice (GMP) standards as outlined in EU Directive 2001/83/EC. Similarly, in the United Kingdom, the Medicines and Healthcare products Regulatory Agency (MHRA) mandates compliance with GMP requirements for the approval and marketing of medicinal products. Post-Brexit, while the UK has its own regulatory framework, it continues to align closely with EU standards to facilitate market access.

Collagen is not listed in the World Health Organization's (WHO) Model List of Essential Medicines as of the latest edition. Consequently, there are no WHO Prequalification programs specifically for collagen products. However, manufacturers must ensure that their collagen products comply with international pharmacopoeia standards, such as the United States Pharmacopeia (USP), British Pharmacopoeia (BP), European Pharmacopoeia (EP), and Indian Pharmacopoeia (IP), to meet global quality expectations.

In India, collagen-based products are regulated by the Central Drugs Standard Control Organization (CDSCO). Depending on their intended use, these products may be classified under different schedules of the Drugs and Cosmetics Act. For instance, collagen products intended for therapeutic use may fall under Schedule H, requiring a prescription for sale. The National Pharmaceutical Pricing Authority (NPPA) monitors the pricing of essential medicines; however, as of March 2026, there is no ceiling price set for collagen products. For export purposes, manufacturers must obtain a No Objection Certificate (NOC) from the Directorate General of Foreign Trade (DGFT), ensuring compliance with export regulations.

As of March 2026, there are no active patents listed for collagen products in the FDA's Orange Book. This absence of patent protection suggests an opportunity for generic competition in the U.S. market. However, the lack of approved ANDAs indicates that market entry may be limited by other factors, such as regulatory challenges or market demand.

In June 2025, the EMA revised its GMP guidelines, emphasizing stricter controls on biological products, including collagen-based therapies. This revision aims to enhance product safety and efficacy standards across member states.

In September 2025, the MHRA updated its post-Brexit regulatory framework, introducing new requirements for the importation of medicinal products, including collagen-based items, into the UK. These changes necessitate that Indian exporters adapt to the updated compliance measures to maintain market access.

In December 2025, the FDA issued a draft guidance document outlining the regulatory considerations for collagen-based medical devices, providing clarity on the approval process and quality standards expected for these products.

In February 2026, the WHO published a report highlighting the importance of quality assurance in the manufacturing of biological products, including collagen, urging manufacturers to adhere to international standards to ensure product safety and efficacy.

In March 2026, the CDSCO announced a streamlined process for the approval of biological products, including collagen-based therapies, aiming to expedite market entry while maintaining stringent safety and efficacy standards.

India's pharmaceutical industry, including collagen production, heavily relies on imports for Key Starting Materials (KSMs) and Active Pharmaceutical Ingredients (APIs), with China being a predominant supplier. Approximately 70% of India's APIs are sourced from China, underscoring a significant dependency. This reliance exposes the supply chain to vulnerabilities, as disruptions in Chinese manufacturing—due to environmental regulations, trade policies, or other factors—can lead to shortages and price volatility in essential raw materials.

For instance, in July 2018, environmental inspections in China led to the shutdown of several chemical plants, causing a ripple effect that impacted global API supplies and escalated costs. Such events highlight the fragility of the supply chain and the potential for significant disruptions in collagen production due to upstream dependencies.

The collagen export market from India is notably concentrated, with the top five exporters accounting for 79.0% of the total export value. GTR Global Care leads with a 42.9% share, followed by Human Biosciences India Limited (16.9%), Caplin Point Laboratories Limited (8.3%), Saga Lifesciences Limited (6.5%), and Aegis Lifesciences Private Limited (4.4%). This high concentration poses a single-source risk; any operational or financial issues within these key exporters could significantly disrupt supply chains.

To mitigate such risks, the Indian government has implemented the Production Linked Incentive (PLI) scheme aimed at enhancing domestic manufacturing capabilities and reducing import dependence. As of September 2025, the PLI schemes across various sectors have resulted in realized investments and measurable increases in production and employment. However, the specific impact of the PLI scheme on collagen production remains to be fully realized, indicating a need for continued monitoring and support to diversify the supplier base.

Global shipping routes critical to India's export logistics, such as the Red Sea and the Strait of Hormuz, have experienced disruptions due to geopolitical tensions. For example, in early 2025, heightened conflicts in the Middle East led to temporary closures of these passages, causing delays and increased shipping costs. Additionally, escalating trade tensions between the United States and China have introduced uncertainties in global trade policies, potentially affecting market access and demand for Indian collagen exports.

Regulatory bodies like the FDA and EMA have issued shortage alerts for various pharmaceuticals in recent years, underscoring the impact of supply chain disruptions on global health. While specific alerts for collagen are not prevalent, the interconnectedness of pharmaceutical supply chains means that disruptions in one area can have cascading effects, emphasizing the need for robust risk management strategies.

• Diversify Supplier Base: Encourage the development of additional domestic collagen producers to reduce reliance on a limited number of exporters.

• Enhance Domestic API Production: Invest in local manufacturing of KSMs and APIs to decrease dependency on imports, particularly from China.

• Strengthen Supply Chain Monitoring: Implement advanced tracking systems to identify and address potential disruptions proactively.

• Develop Alternative Shipping Routes: Explore and establish alternative logistics pathways to mitigate risks associated with geopolitical tensions affecting major shipping lanes.

• Engage in Policy Advocacy: Collaborate with industry associations to advocate for supportive government policies and incentives that bolster domestic production and export capabilities.

RISK_LEVEL: MEDIUM