How India Exports Catheter to the World

Catheters, classified under HS Code 30049099, are medical devices rather than pharmaceutical products; therefore, they are not listed in the FDA's Orange Book, which catalogs approved drug products. Instead, catheters are regulated by the FDA's Center for Devices and Radiological Health (CDRH). The regulatory pathway for catheters typically involves a 510(k) premarket notification submission, demonstrating that the device is substantially equivalent to a legally marketed predicate device. In certain cases, a Premarket Approval (PMA) application may be required, especially for devices that are considered high-risk.

Given the presence of 33 active Indian exporters and 36 destination countries, it is crucial for manufacturers to ensure compliance with FDA regulations to access the U.S. market. This includes adhering to Quality System Regulations (QSR) and, if applicable, obtaining clearance or approval through the appropriate regulatory pathway.

In the European Union, catheters are regulated under the Medical Devices Regulation (MDR) (EU) 2017/745, which came into full effect in May 2021. Manufacturers must obtain CE marking by demonstrating compliance with the MDR's requirements, including clinical evaluation and conformity assessment procedures. Similarly, in the United Kingdom, following Brexit, medical devices are regulated by the Medicines and Healthcare products Regulatory Agency (MHRA). Manufacturers must register their devices with the MHRA and, depending on the device class, may require assessment by a UK Approved Body to obtain the UKCA marking.

Catheters are not listed in the World Health Organization's (WHO) Model List of Essential Medicines, as this list primarily focuses on pharmaceutical products. However, catheters are recognized as essential medical devices in various WHO guidelines and are subject to international standards such as those set by the International Organization for Standardization (ISO), including ISO 10555 for sterile, single-use intravascular catheters. Compliance with these standards ensures the safety and efficacy of catheters in global markets.

In India, catheters are classified as medical devices and are regulated by the Central Drugs Standard Control Organisation (CDSCO). Manufacturers must obtain a license under the Medical Device Rules, 2017, which came into effect in January 2018. For export purposes, the CDSCO requires a No Objection Certificate (NOC). As per the revised guidance issued in May 2025, manufacturers of unapproved formulations, including fixed-dose combinations (FDCs), can submit approval from a Stringent Regulatory Authority (SRA) such as the US, EU, Canada, Japan, Australia, or Switzerland if approval from the importing country's National Regulatory Authority (NRA) is not available.

Catheters, being medical devices, are not subject to the same patent and exclusivity considerations as pharmaceutical products. However, manufacturers may hold patents on specific designs or technologies related to catheters, which can impact market competition. The presence of 33 active Indian exporters indicates a competitive market, suggesting that any existing patents are either non-blocking or have expired, allowing for multiple manufacturers to produce and export these devices.

In July 2025, the CDSCO revised its guidance document for issuing export NOCs for new drug formulations, introducing relaxations for fixed-dose combinations (FDCs) and research-oriented drug batches. Manufacturers of unapproved FDCs can now submit regulatory approvals from Stringent Regulatory Authorities (SRAs) such as the United States, European Union, Canada, Australia, and Japan as an alternative to approvals from the National Regulatory Authority (NRA) of the importing country.

Additionally, the revised guidance introduces a two-step NOC process: registration at the zonal CDSCO office followed by consignment clearance at the port. Export NOCs are now valid for one year or until the approved quantity is exhausted, whichever comes first. Unused stock of formulations with less than 60% shelf life, or APIs with under three months' shelf life, must be destroyed under State Licensing Authority (SLA) supervision.

These developments reflect India's efforts to streamline export procedures and align with international regulatory standards, facilitating the export of medical devices such as catheters to various global markets.

India's catheter manufacturing industry heavily relies on Active Pharmaceutical Ingredients (APIs) and Key Starting Materials (KSMs) imported from China. China controls approximately 70–80% of the global KSM supply and 60–70% of the global intermediate supply, making it a dominant player in the API sector. This dependency exposes Indian manufacturers to significant supply chain risks, as any disruption in Chinese production or export policies can directly impact the availability and cost of essential raw materials.

The COVID-19 pandemic highlighted the vulnerabilities of this reliance. During the crisis, Chinese factory shutdowns led to immediate shortages of APIs, causing price surges and production slowdowns in India. This situation underscored the critical need for India to develop a more self-sufficient API manufacturing capability to mitigate future risks associated with external supply disruptions.

Our proprietary trade data indicates a high concentration among Indian catheter exporters. The top five exporters account for 80.3% of total exports, with MEDI EXPRESS SUPPLIES alone holding a 43.9% share. Such concentration poses a significant single-source risk; any operational or financial issues within these key suppliers could disrupt the entire supply chain.

To address this, the Indian government has implemented the Production Linked Incentive (PLI) scheme aimed at boosting domestic API and KSM production. In October 2024, two greenfield plants were inaugurated under this scheme to manufacture critical molecules like Penicillin G and Clavulanic Acid, essential for various antibiotics. While these initiatives are steps toward reducing import dependence, the effectiveness of the PLI scheme in diversifying supplier bases and mitigating single-source risks remains to be fully realized.

Geopolitical tensions and shipping disruptions significantly impact the global supply chain for medical devices, including catheters. The 2026 Strait of Hormuz crisis, which began in March 2026, led to a sharp decline in maritime transit, affecting about 20% of the world's daily oil supply and causing major shipping firms to suspend operations in the area. This disruption has had cascading effects on global shipping routes, leading to increased transportation costs and delays for medical supplies.

Additionally, ongoing U.S.-China trade tensions have introduced uncertainties in the supply of APIs and KSMs. The U.S. Pharmacopeia's Medicine Supply Map report from October 2025 highlighted that 41% of key starting materials used in U.S.-approved medicines are solely sourced from China, emphasizing the global reliance on Chinese supplies. Such geopolitical dynamics necessitate a reassessment of supply chain strategies to ensure resilience against future disruptions.

• Diversify Supplier Base: Identify and qualify alternative suppliers in different geographic regions to reduce dependency on a single source.

• Enhance Domestic Production: Invest in local API and KSM manufacturing capabilities to build a more self-reliant supply chain.

• Strengthen Supplier Relationships: Develop strategic partnerships with key suppliers to ensure priority access during global disruptions.

• Implement Advanced Risk Monitoring: Utilize real-time data analytics to monitor geopolitical developments and shipping routes, enabling proactive risk management.

• Increase Inventory Buffers: Maintain higher safety stock levels of critical components to cushion against supply chain interruptions.

RISK_LEVEL: HIGH