Who Supplies Terbinafine to India from ISRAEL

To import finished pharmaceutical formulations containing Terbinafine into India, foreign manufacturers must obtain an Import Registration Certificate and an Import License from the Central Drugs Standard Control Organization (CDSCO). The application process involves submitting Form 40 or 41, along with necessary documents such as the Certificate of Pharmaceutical Product (CoPP), Good Manufacturing Practice (GMP) certificate, and stability data. The registration process typically takes 6 to 12 months, depending on the completeness of the application and compliance with CDSCO requirements. For formulations under HS Code 30049099, the registration must demonstrate compliance with the Drugs and Cosmetics Act, 1940, and the Drugs and Cosmetics Rules, 1945. Additionally, a No Objection Certificate (NOC) from the Ministry of Health and Family Welfare is required for the importation of drugs.

Imported pharmaceutical formulations containing Terbinafine must undergo quality testing at CDSCO-approved laboratories in India. Each batch requires a Certificate of Analysis (CoA) confirming compliance with Indian Pharmacopoeia standards. Stability data, particularly for ICH Zone IV conditions, must be provided to ensure product efficacy and safety in India's climate. Upon arrival, customs drug inspectors perform port inspections to verify the authenticity and quality of the products. If a batch fails to meet the required standards, it may be rejected, leading to potential financial losses and reputational damage for the importer.

Between 2024 and 2026, the CDSCO has implemented stricter regulations for the importation of pharmaceutical products, including mandatory registration and licensing for all imported drugs. The introduction of the Production Linked Incentive (PLI) scheme has incentivized domestic manufacturing, potentially reducing reliance on imported formulations. Bilateral agreements between India and Israel have facilitated smoother trade relations, but no specific concessions have been granted for Israeli pharmaceutical imports.

India imports finished Terbinafine formulations primarily due to the availability of patented or branded products not manufactured domestically. Specific dosage forms, such as certain tablet strengths or combination therapies, may not be produced locally. Despite a robust domestic pharmaceutical industry, there remains a dependency on imports to meet the diverse therapeutic needs of the population. The market size for Terbinafine formulations in India is substantial, with a growing demand for antifungal treatments.

The Basic Customs Duty (BCD) for pharmaceutical formulations under HS Code 30049099 is 10%. An additional Social Welfare Surcharge (SWS) of 10% is applied, resulting in a total duty of 20%. The Goods and Services Tax (GST) at 12% is applicable on the landed value, including customs duties. There are no exemptions or concessional rates for imports from Israel, and no anti-dumping duties are currently imposed on these products.

Israel's pharmaceutical industry is renowned for its high-quality standards and innovative formulations. Indian importers source Terbinafine formulations from Israel to access patented products, specialized dosage forms, and advanced manufacturing technologies not available domestically. While other countries like China, Germany, and the United States also supply Terbinafine formulations, Israel's competitive advantage lies in its stringent quality control and adherence to international regulatory standards. Israel's share in India's Terbinafine import market is modest but significant, reflecting its niche position.

India imports Terbinafine formulations from Israel to access high-quality, patented products and specialized dosage forms not available domestically. Israeli manufacturers offer advanced technologies and stringent quality control measures, ensuring the efficacy and safety of the formulations. Specific formulations, such as certain tablet strengths or combination therapies, are sourced from Israel to meet the diverse therapeutic needs of the Indian market.

When compared to other sources like China, the European Union, and the United States, Israel offers a competitive edge in terms of product quality and regulatory compliance. Israeli pharmaceutical products are known for their adherence to international standards, which is crucial for the Indian market's stringent regulatory requirements. While other countries may offer lower prices, Israel's reputation for quality and reliability makes it a preferred choice for Indian importers seeking premium formulations.

Importing Terbinafine formulations from Israel involves certain risks, including potential supply chain disruptions due to geopolitical factors, currency fluctuations between ILS and INR, and changes in Israeli export regulations. Quality incidents, such as batch rejections or recalls, can also impact the supply chain. To mitigate these risks, Indian importers should maintain diversified supplier bases, monitor geopolitical developments, and establish robust quality assurance processes.

1. 1Dual-Sourcing: Engage multiple suppliers to reduce dependency on a single source and mitigate supply chain risks.
2. 2Inventory Planning: Maintain optimal inventory levels to buffer against potential supply disruptions.
3. 3Payment Terms: Negotiate favorable payment terms, such as Letters of Credit (LC), Documents Against Acceptance (DA), or Documents Against Payment (DP), to manage financial risks.
4. 4Minimum Order Quantities (MOQs): Clarify MOQs with suppliers to ensure cost-effectiveness and meet market demand.
5. 5Supplier Qualification: Conduct thorough due diligence on suppliers, including audits and assessments of their manufacturing facilities and quality control processes.

1. 1DGFT Importer Exporter Code (IEC): Obtain an IEC from the Directorate General of Foreign Trade.
2. 2CDSCO Registration: Apply for registration under Form 40 or 41, providing necessary documentation.
3. 3Drug Import License: Secure a license from the CDSCO for importing pharmaceutical products.
4. 4No Objection Certificate (NOC):