How India Exports Churna to the World

As of March 2026, "Churna," classified under HS Code 30049011, is an Ayurvedic medicinal product traditionally used in India. The FDA's Orange Book, which lists approved drug products, does not include any entries for "Churna" or similar Ayurvedic formulations. Consequently, there are no approved Abbreviated New Drug Applications (ANDAs) for "Churna" in the United States. This absence indicates that "Churna" has not undergone the FDA's rigorous approval process required for marketing pharmaceutical products in the U.S.

Despite the lack of FDA approval, the United States accounted for 8.4% of "Churna" exports from India between 2022 and 2026, highlighting a demand within the U.S. market. However, without FDA approval, "Churna" cannot be legally marketed as a drug in the U.S. Importers and distributors must navigate complex regulatory pathways, potentially classifying "Churna" as a dietary supplement under the Dietary Supplement Health and Education Act (DSHEA) of 1994. This classification requires adherence to specific labeling and marketing regulations, including the prohibition of disease-related claims.

In the European Union and the United Kingdom, "Churna" falls under the category of traditional herbal medicinal products. The European Medicines Agency (EMA) and the UK's Medicines and Healthcare products Regulatory Agency (MHRA) require such products to obtain a Traditional Herbal Registration (THR) before marketing. This process involves demonstrating safety and traditional use over a period of at least 30 years, including 15 years within the EU.

Compliance with Good Manufacturing Practice (GMP) standards is mandatory for all medicinal products in the EU and UK. Manufacturers exporting "Churna" to these markets must ensure their facilities meet EU GMP requirements, which are enforced through regular inspections. Failure to comply can result in import restrictions or product recalls.

"Churna" is not listed in the World Health Organization's (WHO) Model List of Essential Medicines, which primarily includes allopathic medicines. Consequently, it has not undergone the WHO Prequalification Programme, designed to ensure the quality, safety, and efficacy of medicinal products.

Regarding pharmacopoeial standards, "Churna" formulations are typically described in the Ayurvedic Pharmacopoeia of India (API). However, they are not included in the United States Pharmacopeia (USP), British Pharmacopoeia (BP), or European Pharmacopoeia (EP). This exclusion may pose challenges for exporters, as compliance with these pharmacopoeias is often a prerequisite for market entry in various countries.

In India, "Churna" is classified as an Ayurvedic medicine and is regulated by the Central Drugs Standard Control Organisation (CDSCO) under the Drugs and Cosmetics Act, 1940. It does not fall under Schedules H, H1, or X, which pertain to allopathic prescription drugs, nor is it classified as an over-the-counter (OTC) allopathic medicine.

The National Pharmaceutical Pricing Authority (NPPA) oversees the pricing of scheduled formulations under the Drugs (Prices Control) Order (DPCO), 2013. As of March 2025, the NPPA had fixed ceiling prices for 928 scheduled formulations. However, Ayurvedic medicines like "Churna" are generally not included in these price controls, allowing manufacturers greater flexibility in pricing.

For export purposes, manufacturers must obtain a No Objection Certificate (NOC) from the CDSCO, ensuring that the product complies with the regulatory requirements of the importing country. This process involves providing detailed product information, including composition, manufacturing process, and quality control measures.

"Churna" formulations, being traditional Ayurvedic preparations, are generally not subject to patent protection. This lack of exclusivity allows multiple manufacturers to produce and market "Churna" without infringing on intellectual property rights. Consequently, the market is characterized by significant generic competition, both domestically and internationally.

In November 2025, the NPPA revised the ceiling prices of several key medicines under the DPCO, 2013. While this revision primarily affected allopathic medicines, it underscores the Indian government's ongoing efforts to regulate drug prices and ensure affordability.

In December 2025, the NPPA fixed the retail prices of 37 new drug formulations, covering a wide range of commonly used medicines, including those for hypertension, diabetes, respiratory disorders, allergies, and mental health conditions. This action reflects the authority's commitment to controlling drug prices and ensuring access to essential medicines.

These developments highlight the dynamic nature of pharmaceutical regulation in India, which can indirectly impact the Ayurvedic medicine sector by influencing market dynamics and pricing strategies.

India's pharmaceutical industry, including the production of Churna, 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 manufacturers, creating a significant dependency. This reliance exposes the supply chain to vulnerabilities, as any disruption in Chinese production or export policies can lead to shortages and price volatility in the Indian market.

The COVID-19 pandemic underscored these risks when Chinese factory shutdowns led to immediate scarcities of essential APIs and KSMs, causing price surges for common medications. Recognizing this, the Indian government initiated the Production Linked Incentive (PLI) scheme in October 2024 to bolster domestic manufacturing of critical pharmaceutical ingredients. Two new plants were inaugurated under this scheme to produce Penicillin G, 6-APA, and Clavulanic Acid—key molecules in antibiotic production that had not been manufactured domestically for over two decades.

Our proprietary trade data indicates that the top five exporters of Churna from India account for 43.9% of the total export value, with SHETH BROTHERS leading at 12.5%. This concentration suggests a moderate risk, as disruptions affecting these key suppliers could significantly impact the overall supply chain.

The PLI scheme aims to mitigate such risks by encouraging diversification and strengthening domestic production capabilities. However, the effectiveness of this initiative in reducing supplier concentration and single-source dependency remains to be fully realized.

Recent geopolitical tensions have further strained the pharmaceutical supply chain. The closure of the Strait of Hormuz in March 2026 disrupted global shipping routes, delaying the transport of APIs and KSMs to India and other manufacturing hubs. Additionally, increased instability in the Red Sea and Suez Canal has forced shipping companies to reroute vessels around Africa's Cape of Good Hope, leading to longer transit times and higher shipping costs.

These disruptions have caused delays in the delivery of essential raw materials, impacting production schedules and potentially leading to shortages of Churna in key markets. The FDA has acknowledged such supply chain challenges, emphasizing the need for proactive measures to prevent and mitigate shortages of regulated products.

• Diversify Supplier Base: Expand the network of API and KSM suppliers beyond China to reduce dependency and enhance supply chain resilience.

• Strengthen Domestic Manufacturing: Accelerate the implementation of the PLI scheme to boost local production of critical pharmaceutical ingredients, thereby decreasing reliance on imports.

• Enhance Supply Chain Monitoring: Implement advanced tracking systems to monitor the movement of raw materials and finished products, enabling prompt responses to potential disruptions.

• Develop Contingency Plans: Establish comprehensive contingency strategies to address potential geopolitical and logistical challenges, ensuring continuity in production and distribution.

• Engage in International Collaboration: Foster partnerships with global regulatory bodies and industry stakeholders to share information and coordinate responses to supply chain disruptions.

RISK_LEVEL: MEDIUM