How India Exports Zinc to the World

In the United States, zinc-based pharmaceutical products are subject to regulation by the Food and Drug Administration (FDA). The FDA's Orange Book lists approved drug products, including those containing zinc compounds such as zinc sulfate, zinc chloride, and zinc oxide. These listings indicate that multiple Abbreviated New Drug Applications (ANDAs) have been approved for zinc-containing products, reflecting a competitive generic market. For instance, zinc sulfate is recognized in the Orange Book, underscoring its established therapeutic use.

The regulatory pathway for zinc-based products typically involves the submission of an ANDA, demonstrating bioequivalence to a reference listed drug. Given the substantial number of active Indian exporters (791) and the significant export volume to the U.S., compliance with FDA regulations, including adherence to Current Good Manufacturing Practices (cGMP), is imperative to ensure market access and maintain product quality standards.

In the European Union (EU) and the United Kingdom (UK), zinc-containing medicinal products require marketing authorization from the European Medicines Agency (EMA) or the UK's Medicines and Healthcare products Regulatory Agency (MHRA), respectively. Applicants must demonstrate product quality, safety, and efficacy, adhering to the EU's Good Manufacturing Practice (GMP) guidelines. Compliance with these standards is essential for Indian exporters targeting these markets.

Zinc is included in the World Health Organization's (WHO) Model List of Essential Medicines, highlighting its importance in global health. The 22nd edition, published in September 2021, lists zinc sulfate for the treatment of acute diarrhea in children. Additionally, zinc compounds are recognized in various pharmacopoeias, including the United States Pharmacopeia (USP), British Pharmacopoeia (BP), European Pharmacopoeia (EP), and Indian Pharmacopoeia (IP), establishing standardized quality benchmarks for pharmaceutical formulations.

In India, zinc-based pharmaceutical products are regulated by the Central Drugs Standard Control Organisation (CDSCO). Zinc sulfate is classified under Schedule H, indicating that it is a prescription drug requiring medical supervision. The Drug Price Control Order (DPCO), enforced by the National Pharmaceutical Pricing Authority (NPPA), sets ceiling prices for essential medicines. As of March 2026, the ceiling price for zinc sulfate tablets (20 mg) is ₹0.17 per tablet, ensuring affordability and accessibility. Exporters must obtain a No Objection Certificate (NOC) from the Directorate General of Foreign Trade (DGFT) for the export of zinc formulations, ensuring compliance with national regulations.

Zinc-based pharmaceutical products, such as zinc sulfate, are generally off-patent, allowing for robust generic competition. This competitive landscape is reflected in the significant number of ANDA approvals and the presence of multiple manufacturers in the market.

In June 2025, the NPPA revised the ceiling price of zinc sulfate tablets, reducing it by 5% to ₹0.17 per tablet, aiming to enhance affordability.

In September 2025, the CDSCO updated the risk classification of 119 radiotherapy devices under the Medical Devices Rules, 2017, aligning with international standards.

In December 2025, the CDSCO released a draft classification of cardiovascular and neurological medical devices, inviting public comments to refine regulatory frameworks.

In January 2026, the FDA updated the Orange Book to include new therapeutic equivalence evaluations for zinc-containing products, reflecting ongoing developments in the generic drug market.

In March 2026, the WHO published the 23rd edition of the Model List of Essential Medicines, reaffirming the inclusion of zinc sulfate for pediatric diarrhea treatment, underscoring its continued global health significance.

These developments highlight the dynamic regulatory environment affecting zinc-based pharmaceutical products, emphasizing the need for exporters to stay informed and compliant with evolving standards.

India's pharmaceutical industry, often referred to as the "pharmacy of the world," heavily relies on China for Active Pharmaceutical Ingredients (APIs) and Key Starting Materials (KSMs). Approximately 70% of India's API requirements are fulfilled by Chinese suppliers. This dependency exposes the supply chain to significant risks, as any disruption in Chinese production or export policies can lead to shortages and price volatility. For instance, during the COVID-19 pandemic, China's factory shutdowns resulted in immediate API shortages and escalated prices for essential drugs.

To mitigate these vulnerabilities, the Indian government has initiated the Production Linked Incentive (PLI) scheme, aiming to bolster domestic API and KSM manufacturing. In October 2024, two greenfield plants were inaugurated under this scheme to produce critical molecules like Penicillin G and 6-Aminopenicillanic acid (6-APA), which are vital for common antibiotics. These efforts are projected to reduce India's import dependence on key pharmaceutical ingredients by half.

Our proprietary trade data indicates that the top five exporters of zinc from India account for 43.2% of the total export value, with APEX LABORATORIES PRIVATE LIMITED alone contributing 23.0%. This high supplier concentration poses a single-source risk; any operational or compliance issues within these key companies could disrupt the supply chain. For example, in February 2025, the FDA issued warning letters to API manufacturers in India and China for significant deviations from current Good Manufacturing Practice (cGMP), highlighting ongoing quality concerns.

The PLI scheme is a strategic move to diversify and strengthen the supplier base by incentivizing domestic production of APIs and KSMs. By reducing reliance on a limited number of suppliers and encouraging new entrants into the market, this initiative aims to enhance supply chain resilience and mitigate risks associated with supplier concentration.

Geopolitical tensions and shipping disruptions significantly impact the pharmaceutical supply chain. The closure of the Strait of Hormuz in March 2026, following military conflicts involving Iran, has disrupted global supply chains, affecting the distribution of pharmaceuticals from India. Approximately 3,200 ships are stalled within the Persian Gulf, causing worldwide logistical shortages and rising prices. Additionally, increased instability in the Red Sea and Suez Canal has forced companies to reroute ships around Africa’s Cape of Good Hope, adding delays and fuel surcharges.

The FDA actively monitors such disruptions and collaborates with industry stakeholders to prevent and mitigate shortages of FDA-regulated products. Their role includes working with government partners, regulated industry, health care providers, international partners, and other interested parties to sustain and strengthen capabilities to identify, prevent, mitigate, and respond to supply chain signals, constraints, and shortages.

• Diversify Supplier Base: Encourage partnerships with multiple API and KSM suppliers across different regions to reduce dependency on a single source.

• Enhance Domestic Production: Leverage government incentives like the PLI scheme to invest in local manufacturing facilities for critical pharmaceutical ingredients.

• Strengthen Quality Compliance: Implement robust quality control systems to ensure adherence to cGMP standards, minimizing the risk of regulatory actions.

• Develop Contingency Plans: Establish alternative shipping routes and logistics strategies to mitigate the impact of geopolitical disruptions on supply chains.

• Monitor Regulatory Developments: Stay informed about international regulatory changes and geopolitical events that could affect supply chain stability.

RISK_LEVEL: MEDIUM