Who Supplies Pomalidomide to India from ISRAEL

Importing finished pharmaceutical formulations containing Pomalidomide into India requires compliance with the Drugs and Cosmetics Act, 1940, and associated rules. The Central Drugs Standard Control Organization (CDSCO) mandates that all imported drugs be registered and approved before distribution. The registration process involves obtaining a Registration Certificate (Form 41) from CDSCO, which certifies the drug's safety, efficacy, and quality. An Import License is also required, issued by the Directorate General of Foreign Trade (DGFT), permitting the importation of the drug. The application for registration must include comprehensive documentation, such as the Certificate of Pharmaceutical Product (CoPP), stability data (preferably ICH Zone IV), and a No Objection Certificate (NOC) from the manufacturer. The timeline for obtaining these approvals can vary but typically ranges from 6 to 12 months, depending on the completeness of the application and the regulatory review process.

Imported pharmaceutical formulations are subject to quality testing by CDSCO-approved laboratories to ensure compliance with Indian Pharmacopoeia standards. Each batch of the imported product must be accompanied by a Certificate of Analysis (CoA) from the manufacturer, detailing the product's composition, quality control measures, and compliance with specified standards. Stability data, particularly for ICH Zone IV conditions, is essential to demonstrate the product's shelf-life and storage requirements. Upon arrival at Indian ports, customs drug inspectors conduct inspections to verify the authenticity of the documentation and the quality of the product. If a batch fails to meet the required standards, it may be rejected, re-exported, or destroyed, depending on the severity of the non-compliance.

Between 2024 and 2026, the CDSCO has implemented stricter regulations for the importation of pharmaceutical products to enhance drug safety and efficacy. Notably, on April 8, 2025, the CDSCO mandated that all imported drugs, including finished formulations, must obtain both import registration and an import license before distribution in India. This directive aims to prevent the sale of unapproved or illegal medicines in the Indian market. Additionally, the introduction of the Production Linked Incentive (PLI) scheme has incentivized domestic manufacturing, potentially affecting the demand for imported formulations. While the PLI scheme primarily targets domestic production, it may influence import patterns as companies assess the cost-effectiveness of sourcing domestically versus importing.

India imports finished Pomalidomide formulations to meet the therapeutic needs of patients, particularly those requiring specialized dosage forms not readily available domestically. The domestic production of Pomalidomide formulations may be limited due to patent protections, technological constraints, or economic considerations. The market size for Pomalidomide formulations in India is substantial, with imports totaling approximately $4.4 million across 108 exporters to 52 countries. This indicates a significant demand for Pomalidomide formulations, driven by the need for effective treatments in oncology and related fields.

The import duty structure for finished pharmaceutical formulations under HS Code 30049099 includes a Basic Customs Duty (BCD) of 10%, an Integrated Goods and Services Tax (IGST) of 12%, and a Social Welfare Surcharge (SWS) of 10% on the BCD. This results in a total landed duty of approximately 23.6%. There are no specific exemptions or concessional duties for imports from Israel under this HS code. Importers should account for these duties when calculating the total cost of importing Pomalidomide formulations from Israel.

Israel's pharmaceutical industry is renowned for its high-quality standards, innovative formulations, and adherence to international regulatory requirements. Indian importers source Pomalidomide formulations from Israel due to these competitive advantages, as well as the availability of specialized dosage forms and formulations that may not be produced domestically. While other countries, such as China, Germany, and the United States, also supply Pomalidomide formulations, Israel's reputation for quality and reliability positions it favorably in the Indian market. Israel's share in India's Pomalidomide import market is notable, reflecting the trust and preference Indian buyers have for Israeli pharmaceutical products.

India imports Pomalidomide formulations from Israel due to the country's advanced pharmaceutical manufacturing capabilities, adherence to international quality standards, and the availability of specialized formulations not produced domestically. Israeli manufacturers offer innovative dosage forms and formulations that cater to specific therapeutic needs, ensuring efficacy and safety. The trust in Israeli pharmaceutical products is bolstered by the country's robust regulatory framework and consistent product quality.

When compared to other sources such as China, Germany, and the United States, Israel offers a competitive edge in terms of product quality, regulatory compliance, and innovation. Israeli pharmaceutical products are known for their high standards and reliability, which are crucial for the Indian market's stringent requirements. While other countries may offer cost advantages, Israel's reputation for quality and consistency makes it a preferred choice for importing Pomalidomide formulations.