How India Exports Verapamil to the World

In the United States, Verapamil has been approved through multiple Abbreviated New Drug Applications (ANDAs), facilitating the entry of generic versions into the market. For instance, Mylan Pharmaceuticals, Inc. received approval for Verapamil Hydrochloride Extended-Release Capsules under ANDA No. 75-138 on April 20, 1999. The presence of numerous ANDA approvals underscores the competitive landscape and the established regulatory pathway for Verapamil in the U.S. market.

Regarding import alerts, as of October 22, 2024, the FDA issued Import Alert 66-66, which pertains to Active Pharmaceutical Ingredients (APIs) that appear to be misbranded under section 502(f)(1) due to non-compliance with labeling exemptions specified in 21 CFR 201.122. While this alert is not specific to Verapamil, it highlights the FDA's stringent oversight on API imports, emphasizing the necessity for Indian exporters to adhere strictly to U.S. regulatory requirements to ensure uninterrupted market access.

In the European Union, Verapamil is subject to national marketing authorizations, with oversight provided by the European Medicines Agency (EMA) and national competent authorities. The EMA's Periodic Safety Update Report (PSUR) single assessment procedure, PSUSA/00003105/202001, concluded in December 2020, led to variations in the product information for Verapamil-containing medicines. These changes were based on data indicating potential drug-drug interactions and adverse effects, necessitating updates to ensure patient safety. (ema.europa.eu)

In the United Kingdom, the Medicines and Healthcare products Regulatory Agency (MHRA) continues to regulate Verapamil post-Brexit, aligning with EU standards to maintain consistency in safety and efficacy evaluations. Compliance with Good Manufacturing Practice (GMP) requirements, as stipulated by the EU and UK, is mandatory for manufacturers exporting to these markets.

Verapamil is included in the World Health Organization's (WHO) Model List of Essential Medicines, underscoring its significance in global health. This inclusion mandates adherence to international pharmacopoeial standards, such as those outlined in the United States Pharmacopeia (USP), British Pharmacopoeia (BP), European Pharmacopoeia (EP), and Indian Pharmacopoeia (IP). Compliance with these standards ensures the quality, safety, and efficacy of Verapamil across diverse healthcare settings.

In India, Verapamil is classified under Schedule H of the Drugs and Cosmetics Act, indicating that it is a prescription-only medication. The National Pharmaceutical Pricing Authority (NPPA) oversees the pricing of essential medicines; however, as of March 2026, Verapamil is not listed under the Drugs (Prices Control) Order (DPCO), implying no ceiling price is currently imposed. For exports, the Directorate General of Foreign Trade (DGFT) mandates a No Objection Certificate (NOC) to ensure compliance with national regulations and to monitor the quality of pharmaceutical exports.

The primary patents for Verapamil have expired, facilitating the proliferation of generic versions in global markets. This expiration has intensified competition among manufacturers, particularly Indian exporters, who have capitalized on the opportunity to supply cost-effective generics to international markets.

In December 2025, the NPPA announced a revision of the ceiling prices for several cardiovascular drugs; however, Verapamil remained unaffected, allowing manufacturers to maintain their pricing strategies.

In January 2026, the EMA initiated a review of calcium channel blockers, including Verapamil, to assess their safety profiles in light of new clinical data. This ongoing evaluation may lead to updated guidelines and necessitate adjustments in product information.

In February 2026, the FDA updated its Import Alert 66-66 to include additional scrutiny on API labeling compliance, emphasizing the need for exporters to ensure accurate and complete labeling to prevent import detentions.

In March 2026, the WHO published the 22nd edition of its Model List of Essential Medicines, reaffirming the inclusion of Verapamil and highlighting its continued importance in global health initiatives.

In March 2026, the CDSCO issued a directive requiring all Verapamil manufacturers to submit updated stability data to ensure ongoing compliance with quality standards, reflecting the agency's commitment to maintaining the integrity of pharmaceutical products.

These developments underscore the dynamic regulatory environment surrounding Verapamil, necessitating vigilant compliance and proactive engagement by exporters to navigate the evolving landscape effectively.

India's pharmaceutical industry, including the production of Verapamil, heavily relies on Active Pharmaceutical Ingredients (APIs) and Key Starting Materials (KSMs) imported from China. Approximately 60–70% of India's APIs and KSMs are sourced from China, making the supply chain vulnerable to disruptions. This dependency was highlighted in June 2024 when environmental regulations in China led to the shutdown of several chemical manufacturing plants, causing significant supply chain disruptions and increased costs for Indian pharmaceutical companies.

To mitigate this risk, the Indian government has implemented the Production Linked Incentive (PLI) scheme, aiming to boost domestic production of critical APIs and KSMs. In October 2024, two greenfield plants were inaugurated under this scheme to manufacture essential molecules like Penicillin G and Clavulanic Acid, marking a step towards reducing import dependence. However, the effectiveness of these initiatives in addressing the broader dependency on Chinese imports remains to be seen.

Our proprietary trade data indicates a high supplier concentration in Verapamil exports from India, with the top five exporters accounting for 94.7% of the market. Notably, CADILA PHARMACEUTICALS LIMITED alone holds a 60.7% share, exporting $67.2 million worth of Verapamil. This concentration poses a significant single-source risk, as any operational or regulatory issues affecting these key suppliers could disrupt the global supply chain.

The PLI scheme aims to diversify and strengthen the supplier base by encouraging more manufacturers to enter the market. While initial steps have been taken, such as the inauguration of new plants in October 2024, the impact on reducing supplier concentration in the Verapamil market is yet to be realized.

Recent geopolitical tensions have further exacerbated supply chain vulnerabilities. In February 2026, the closure of the Strait of Hormuz due to military conflicts disrupted global shipping routes, leading to delays and increased costs for pharmaceutical exports from India. Additionally, instability in the Red Sea and Suez Canal has forced shipping companies to reroute vessels around the Cape of Good Hope, adding significant transit times and expenses.

These disruptions have raised concerns about potential drug shortages. The FDA has been actively monitoring the situation to prevent and mitigate shortages of critical medications, including Verapamil. However, the ongoing geopolitical instability continues to pose a threat to the timely delivery of pharmaceutical products.

• Diversify API and KSM Sources: Encourage the development of alternative suppliers in different regions to reduce dependency on a single country, particularly China.

• Strengthen Domestic Manufacturing: Accelerate the implementation of the PLI scheme to boost local production of critical APIs and KSMs, thereby enhancing supply chain resilience.

• Enhance Supplier Due Diligence: Conduct comprehensive assessments of key suppliers to identify potential risks and develop contingency plans for supply disruptions.

• Monitor Geopolitical Developments: Establish a dedicated team to track geopolitical events that could impact shipping routes and supply chains, enabling proactive responses to emerging threats.

• Develop Strategic Reserves: Maintain buffer stocks of essential APIs and finished products to mitigate the impact of sudden supply chain disruptions.

RISK_LEVEL: HIGH