How India Exports Bhasma to the World

As of March 2026, the FDA's Orange Book does not list any approved Abbreviated New Drug Applications (ANDAs) for Bhasma products. This indicates that no Bhasma formulations have received FDA approval for marketing in the United States. Furthermore, the FDA has issued warnings regarding certain unapproved Ayurvedic products containing harmful levels of heavy metals, such as lead and mercury. In February 2026, the FDA highlighted the risks associated with these products, emphasizing potential health hazards like heavy metal poisoning. Consequently, Bhasma products intended for the U.S. market must undergo rigorous evaluation to ensure compliance with FDA standards, particularly concerning safety and labeling. Given the absence of approved ANDAs and the FDA's stringent stance on unapproved Ayurvedic products, Indian exporters face significant regulatory challenges when entering the U.S. market.

In the European Union, Ayurvedic products like Bhasma are subject to the European Medicines Agency's (EMA) guidelines for traditional herbal medicinal products. To obtain marketing authorization, these products must demonstrate safety, quality, and efficacy. As of March 2026, there are no specific EMA approvals for Bhasma products. In the United Kingdom, the Medicines and Healthcare products Regulatory Agency (MHRA) categorizes medicinal products to determine applicable regulations. The MHRA's categorization lists, updated in February 2026, do not specifically mention Bhasma, indicating that such products may require individual assessment for market entry. Compliance with Good Manufacturing Practice (GMP) standards is mandatory in both jurisdictions, ensuring product quality and safety.

Bhasma products are not included in the World Health Organization's (WHO) Model List of Essential Medicines as of the latest edition. Additionally, these products have not undergone the WHO Prequalification Programme, which assesses the quality, safety, and efficacy of medicinal products. Regarding pharmacopoeial standards, Bhasma formulations are primarily described in the Indian Pharmacopoeia (IP). They are not monographed in the United States Pharmacopeia (USP), British Pharmacopoeia (BP), or European Pharmacopoeia (EP), which may pose challenges for international standardization and acceptance.

In India, Bhasma products are regulated under the Drugs and Cosmetics Act, 1940, and are classified as Ayurvedic medicines. They are not listed under Schedules H, H1, or X, which pertain to allopathic drugs requiring specific prescriptions. As of March 2026, the National Pharmaceutical Pricing Authority (NPPA) has not imposed ceiling prices on Bhasma products, allowing market-driven pricing. For export purposes, manufacturers must obtain a No Objection Certificate (NOC) from the Directorate General of Foreign Trade (DGFT), ensuring compliance with export regulations.

Bhasma products, being traditional Ayurvedic formulations, are generally not subject to patent protection. This lack of exclusivity allows multiple manufacturers to produce and market these products, leading to a competitive market landscape. However, the absence of patent protection also means that manufacturers cannot leverage exclusivity to command premium pricing or market share.

In August 2025, the Indian Ministry of AYUSH introduced new guidelines to enhance the quality control of Ayurvedic products, including Bhasma, aiming to standardize manufacturing processes and ensure product safety. In October 2025, the NPPA conducted a review of Ayurvedic product pricing but did not implement any price controls on Bhasma products, maintaining a market-driven pricing approach. In December 2025, the DGFT streamlined the export NOC process for Ayurvedic products, reducing processing times and facilitating international trade. In January 2026, the WHO released a report emphasizing the need for stringent heavy metal testing in traditional medicines, prompting Indian manufacturers to adopt more rigorous quality control measures. In March 2026, the EMA updated its guidelines for traditional herbal medicinal products, potentially impacting the regulatory pathway for Bhasma products seeking entry into the European market.

India's pharmaceutical industry, including the production of traditional medicines like Bhasma, heavily relies on Active Pharmaceutical Ingredients (APIs) and Key Starting Materials (KSMs) imported from China. Approximately 70% of India's API requirements are fulfilled by Chinese suppliers, underscoring a significant dependency on external sources for critical raw materials. This reliance exposes the supply chain to vulnerabilities, particularly during geopolitical tensions or global disruptions.

The COVID-19 pandemic highlighted these risks when disruptions in Chinese manufacturing led to shortages and price hikes for essential APIs and KSMs. In response, the Indian government initiated the Production Linked Incentive (PLI) scheme in October 2024, aiming to bolster domestic production of key pharmaceutical ingredients and reduce import dependence. Despite these efforts, the transition to self-sufficiency is ongoing, and the industry remains susceptible to external supply chain disturbances.

Analysis of TransData Nexus's proprietary trade data from 2022 to 2026 reveals that the top five exporters of Bhasma from India account for 56.3% of total exports, with AJANTA PHARMA LIMITED leading at a 17.8% share. This concentration indicates a moderate level of supplier dependency, which could pose risks if any of these key exporters face operational challenges.

The PLI scheme, launched in October 2024, aims to mitigate such risks by incentivizing domestic production of APIs and KSMs. While this initiative is a positive step towards reducing reliance on concentrated suppliers, its full impact on diversifying the supplier base and enhancing supply chain resilience will require time to materialize.

Recent geopolitical events have significantly impacted global supply chains. In February 2026, the closure of the Strait of Hormuz disrupted the movement of oil and other critical goods, affecting industries worldwide, including pharmaceuticals. Such disruptions can lead to increased transportation costs and delays, impacting the timely delivery of pharmaceutical products like Bhasma.

Additionally, tensions in the Red Sea and the Strait of Hormuz have forced shipping companies to reroute vessels, further straining logistics and increasing costs. The FDA has acknowledged that geopolitical situations are among the underlying causes of supply chain issues, emphasizing the need for proactive risk management strategies.

• Diversify Supplier Base: Engage with a broader range of suppliers to reduce dependency on a limited number of exporters, thereby enhancing supply chain resilience.

• Strengthen Domestic Production: Accelerate the implementation of the PLI scheme to boost local manufacturing of APIs and KSMs, decreasing reliance on imports.

• Enhance Supply Chain Visibility: Implement advanced tracking and monitoring systems to identify potential disruptions early and develop contingency plans.

• Develop Alternative Shipping Routes: Establish and maintain alternative logistics pathways to mitigate the impact of geopolitical disruptions on transportation.

• Collaborate with Regulatory Bodies: Work closely with organizations like the FDA and WHO to stay informed about potential risks and align mitigation strategies accordingly.

RISK_LEVEL: MEDIUM