How India Exports Streptomycin to the World

In the United States, Streptomycin is approved for use in treating tuberculosis and other bacterial infections. The FDA's Orange Book lists several approved Abbreviated New Drug Applications (ANDAs) for Streptomycin, indicating the presence of multiple generic versions in the market. As of March 2026, there are no active import alerts related to Streptomycin, suggesting compliance with FDA standards by current exporters. The regulatory pathway for Streptomycin involves submission of an ANDA, demonstrating bioequivalence to the reference listed drug, and adherence to Current Good Manufacturing Practices (cGMP). Given the 57 active Indian exporters, it is imperative for each to ensure compliance with FDA regulations to maintain market access.

In the European Union, Streptomycin requires a marketing authorization granted by the European Medicines Agency (EMA) or national competent authorities. The EMA's centralized procedure is applicable for certain medicines, while others may follow decentralized or mutual recognition procedures. Compliance with EU Good Manufacturing Practice (GMP) guidelines is mandatory for manufacturing sites. In the United Kingdom, the Medicines and Healthcare products Regulatory Agency (MHRA) oversees the authorization and regulation of medicines, including Streptomycin. Post-Brexit, the UK has established its own regulatory framework, necessitating separate applications for marketing authorization.

Streptomycin is included in the 24th edition of the WHO Model List of Essential Medicines, published in September 2025, underscoring its importance in treating priority health conditions. The WHO Model List serves as a guide for countries to develop their own national essential medicines lists. Streptomycin is also listed in major pharmacopoeias, including the United States Pharmacopeia (USP), British Pharmacopoeia (BP), European Pharmacopoeia (EP), and Indian Pharmacopoeia (IP), ensuring standardized quality and efficacy across different regions.

In India, Streptomycin is classified under Schedule H of the Drugs and Cosmetics Act, indicating that it is a prescription-only medicine. The National Pharmaceutical Pricing Authority (NPPA) regulates the pricing of essential medicines; however, as of March 2026, Streptomycin 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) for certain pharmaceuticals, ensuring compliance with export regulations.

Streptomycin, discovered in the 1940s, is no longer under patent protection, allowing for generic manufacturing and export without infringement concerns. The absence of patent restrictions has led to a competitive market with multiple manufacturers producing Streptomycin, contributing to its widespread availability and affordability.

In May 2025, the WHO Expert Committee on Selection and Use of Essential Medicines convened to update the Model List, reaffirming Streptomycin's inclusion due to its critical role in treating tuberculosis and other bacterial infections. This underscores the global recognition of Streptomycin's importance in public health.

In January 2026, the WHO published a fact sheet emphasizing the significance of essential medicines, including Streptomycin, in addressing priority health-care needs. The document highlights the necessity for these medicines to be available, affordable, and of assured quality at all times, aligning with the principles of universal health coverage. (who.int)

These developments reflect the ongoing global commitment to ensuring access to essential medicines like Streptomycin, reinforcing its role in combating infectious diseases worldwide.

India's pharmaceutical industry, renowned for its generic drug production, heavily relies on China for Key Starting Materials (KSMs) essential in Active Pharmaceutical Ingredient (API) synthesis. Approximately 60–70% of KSMs are imported from China, making the supply chain vulnerable to disruptions. This dependency is particularly critical for antibiotics like streptomycin, where the unavailability of KSMs can halt production.

Recent events have highlighted this vulnerability. In February 2026, Iran's blockade of the Strait of Hormuz disrupted global trade routes, including those vital for pharmaceutical shipments. This blockade led to significant delays and increased costs in transporting raw materials and finished products. (lemonde.fr) Such geopolitical tensions underscore the risks associated with concentrated sourcing of essential materials.

Our proprietary data indicates that the top five Indian exporters of streptomycin account for 62.8% of total exports, with LABORATE PHARMACEUTICALS INDIA LTD leading at a 22.2% share. This concentration poses a risk, as disruptions affecting these key suppliers could significantly impact global streptomycin availability.

To mitigate such risks, the Indian government has implemented the Production Linked Incentive (PLI) scheme, aiming to boost domestic API and KSM production. Notably, in October 2024, two greenfield plants were inaugurated under this scheme to manufacture critical molecules like Penicillin G and 6-APA, essential for antibiotics. While these initiatives are steps toward reducing import dependence, their impact on the streptomycin supply chain remains to be seen.

The blockade of the Strait of Hormuz in March 2026 has had profound effects on global supply chains, including pharmaceuticals. With over 3,200 ships stalled and 500 more awaiting clearance, the distribution of essential goods, including streptomycin, has been severely disrupted. Additionally, tensions in the Red Sea and the Strait of Hormuz have led to increased shipping costs and delays, further straining the supply chain.

Regulatory bodies like the FDA and EMA have issued shortage alerts for various medications due to these disruptions. While specific alerts for streptomycin have not been reported as of March 2026, the potential for shortages remains high given the current geopolitical climate.

• Diversify Sourcing: Identify and qualify alternative suppliers for KSMs and APIs to reduce dependency on a single country or supplier.

• Enhance Domestic Production: Invest in domestic manufacturing capabilities for critical KSMs and APIs, leveraging government incentives like the PLI scheme.

• Strengthen Supplier Relationships: Develop strategic partnerships with multiple suppliers to ensure a more resilient supply chain.

• Monitor Geopolitical Developments: Establish a dedicated team to track geopolitical events that could impact supply chains and develop contingency plans accordingly.

• Implement Risk Assessment Protocols: Regularly assess the supply chain for vulnerabilities and develop mitigation strategies to address identified risks.

RISK_LEVEL: HIGH