How India Exports Ghrita to the World

As of March 2026, Ghrita does not have any approved Abbreviated New Drug Applications (ANDAs) listed in the FDA's Orange Book. This indicates that no generic versions of Ghrita have received FDA approval for marketing in the United States. The absence of ANDA approvals suggests that Ghrita has not undergone the rigorous FDA review process required for pharmaceutical products. Consequently, its importation and sale in the U.S. market may be subject to regulatory scrutiny, and potential import alerts could be issued if the product does not comply with FDA standards. Given that only 1.4% of Ghrita exports were directed to the United States, it appears that the U.S. market is not a primary destination for this product.

In the European Union and the United Kingdom, medicinal products must obtain marketing authorization from the European Medicines Agency (EMA) or the UK's Medicines and Healthcare products Regulatory Agency (MHRA) before they can be marketed. As of March 2026, there is no record of Ghrita having received such authorization from either agency. This lack of authorization indicates that Ghrita has not been evaluated for safety, efficacy, and quality according to EU and UK standards. Furthermore, compliance with Good Manufacturing Practice (GMP) requirements is mandatory for all medicinal products in these regions. Without proper authorization and GMP certification, the distribution of Ghrita in the EU and UK markets is restricted.

The World Health Organization (WHO) maintains a Model List of Essential Medicines, which identifies medications considered essential for basic healthcare systems. As of the latest edition, Ghrita is not included in this list. Additionally, Ghrita has not undergone the WHO Prequalification Programme, which assesses the quality, safety, and efficacy of medicinal products. Regarding pharmacopoeial standards, Ghrita is not monographed in the United States Pharmacopeia (USP), British Pharmacopoeia (BP), European Pharmacopoeia (EP), or Indian Pharmacopoeia (IP). This absence from major pharmacopoeias suggests a lack of standardized quality specifications for Ghrita on a global scale.

In India, the Central Drugs Standard Control Organization (CDSCO) classifies medicinal products into various schedules under the Drugs and Cosmetics Act. Ghrita, being an Ayurvedic preparation, is regulated under the provisions specific to Ayurvedic, Siddha, and Unani (ASU) drugs. These products are not classified under Schedules H, H1, or X, which pertain to allopathic medicines. The National Pharmaceutical Pricing Authority (NPPA) oversees the pricing of pharmaceutical products; however, as of March 2026, there is no ceiling price set for Ghrita, indicating it is not under price control measures. For export purposes, manufacturers of ASU drugs like Ghrita are required to obtain a No Objection Certificate (NOC) from the Directorate General of Foreign Trade (DGFT) to ensure compliance with export regulations.

As of March 2026, there are no active patents or exclusivity rights associated with Ghrita. This lack of patent protection allows multiple manufacturers to produce and market Ghrita without infringing on intellectual property rights. Consequently, the market may experience competition among various producers, potentially affecting pricing and availability.

In October 2024, the European Commission withdrew the marketing authorization for Gavreto (pralsetinib) in the EU at the request of the marketing authorization holder, Blueprint Medicines (Netherlands) B.V., due to commercial reasons. This decision underscores the dynamic nature of the pharmaceutical market and the importance of continuous evaluation of product viability. (ema.europa.eu)

In July 2023, Roche Registration GmbH withdrew its application for the use of Gazyvaro as a pre-treatment to reduce the risk of cytokine release syndrome associated with Columvi (glofitamab). The withdrawal was based on the company's assessment that further safety data would be required to support the registration. (ema.europa.eu)

These developments highlight the critical role of regulatory compliance and the necessity for comprehensive safety and efficacy data in the pharmaceutical industry.

India's pharmaceutical industry, including the production of traditional formulations like Ghrita, heavily relies on Active Pharmaceutical Ingredients (APIs) and Key Starting Materials (KSMs) imported from China. Approximately 70% of India's APIs are sourced from China, underscoring a significant dependency on Chinese suppliers. This reliance exposes the supply chain to vulnerabilities, particularly when Chinese manufacturers face operational disruptions due to environmental regulations or other factors. For instance, in recent years, numerous Chinese API manufacturers have been shut down for failing to adhere to pollution norms, leading to supply disruptions and cost escalations.

The COVID-19 pandemic further highlighted these vulnerabilities, as lockdowns and factory closures in China led to shortages of essential APIs and KSMs, causing price hikes and production delays in India. This situation emphasized the critical need for India to develop self-reliance in API and KSM production to mitigate such risks in the future.

Our proprietary trade data indicates a high supplier concentration in the export of Ghrita from India. The top five exporters account for 85.9% of the total export value, with GREENSHIP EXPORTS alone contributing 78.8%. This concentration poses a significant single-source risk, as any disruption affecting these key suppliers could severely impact the supply chain.

To address such dependencies, the Indian government introduced the Production Linked Incentive (PLI) scheme in February 2021, aiming to bolster domestic API and KSM production. Under this initiative, two greenfield plants were inaugurated in October 2024 to manufacture critical molecules like Penicillin G and Clavulanic Acid, which are essential for various antibiotics. These efforts are expected to reduce India's import dependence on key pharmaceutical ingredients by half.

Geopolitical tensions and conflicts have significantly disrupted global supply chains, impacting the pharmaceutical industry. The ongoing Iran war, as of March 2026, has effectively halted oil tanker movements through the Strait of Hormuz, a critical chokepoint for global commerce. This disruption has affected the distribution of pharmaceuticals from India, leading to logistical shortages and rising prices.

Additionally, increased instability in the Red Sea and Suez Canal has forced shipping companies to reroute vessels around Africa's Cape of Good Hope, resulting in delays and increased transportation costs. Air cargo has also been impacted due to closed airspace in several Middle Eastern countries, further straining the supply chain for high-value goods like pharmaceuticals.

• Diversify Supplier Base: Encourage the development of multiple domestic suppliers for Ghrita and its raw materials to reduce dependency on a few key exporters.

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

• Strengthen Supply Chain Resilience: Develop contingency plans and alternative logistics routes to mitigate the impact of geopolitical disruptions on shipping and transportation.

• Invest in Infrastructure: Improve domestic manufacturing infrastructure to support increased production capacity and ensure compliance with environmental regulations.

• Monitor Regulatory Compliance: Establish robust quality control measures to ensure that domestic API manufacturers adhere to international standards, reducing the risk of regulatory actions that could disrupt supply.

RISK_LEVEL: HIGH