Who Supplies Pembrolizumab to India from SWITZERLAND

To import finished pharmaceutical formulations containing Pembrolizumab into India, the foreign manufacturer must obtain a Registration Certificate and an Import License from the Central Drugs Standard Control Organization (CDSCO). The application process involves submitting Form 40/41 to CDSCO, along with necessary documentation such as a Certificate of Pharmaceutical Product (CoPP), Good Manufacturing Practice (GMP) certificate, and stability data. The timeline for import drug registration varies but typically ranges from 6 to 12 months. For formulations under HS Code 30021500, compliance with the Drugs and Cosmetics Act, 1940, and the Drugs and Cosmetics Rules, 1945, is mandatory.

Imported pharmaceutical formulations must undergo quality testing at CDSCO-approved laboratories. Batch-wise testing is required, and a Certificate of Analysis (CoA) must accompany each shipment. Stability data, adhering to International Council for Harmonisation (ICH) guidelines for Zone IV, is necessary to demonstrate product stability under Indian climatic conditions. Port inspection by customs drug inspectors ensures compliance with Indian Pharmacopoeia standards. If a batch fails quality testing, it may be rejected, leading to potential delays or re-exportation.

In April 2025, the Indian government introduced new regulations requiring import registration and licenses for all imported medicines, including finished formulations containing Pembrolizumab. This measure aims to prevent the sale of unapproved or illegal medicines in the Indian market. The policy emphasizes compliance with the Drugs and Cosmetics Act and Rules, ensuring that imported drugs meet quality, safety, and efficacy standards.

India imports finished Pembrolizumab formulations primarily due to the presence of patented and branded products not manufactured domestically. Specific dosage forms, such as injections, are in demand, and domestic production capacity does not meet the total market requirement. The market size for Pembrolizumab formulations in India is substantial, with imports accounting for a significant portion of the total demand.

The Basic Customs Duty (BCD) for HS Code 30021500 is 10%. An Integrated Goods and Services Tax (IGST) of 12% is levied on imports. Additionally, a Social Welfare Surcharge (SWS) of 10% applies to the customs duty component. Exemptions or concessional rates may apply under specific trade agreements or government notifications. The total landed duty, including all applicable taxes and surcharges, is approximately 23.536%.

India sources finished Pembrolizumab formulations from Switzerland due to the country's strong pharmaceutical manufacturing capabilities, adherence to international quality standards, and the availability of patented formulations not produced domestically. Switzerland's share in India's Pembrolizumab import market is notable, with other suppliers such as China, Germany, and the United States also participating. Switzerland's competitive advantage lies in its reputation for high-quality products and compliance with stringent regulatory requirements.

India imports finished Pembrolizumab formulations from Switzerland due to the availability of patented products not manufactured domestically, the need for specific dosage forms, and the lack of sufficient domestic production capacity. Switzerland's adherence to international quality standards and regulatory compliance further make it a preferred source.

Compared to other origins like China, the European Union, and the United States, Switzerland offers high-quality products with stringent regulatory compliance. While other countries may offer competitive pricing, Switzerland's reputation for quality and reliability provides a unique advantage in the Indian market.

Potential risks include single-source dependency, currency fluctuations, regulatory changes, quality incidents, and shipping disruptions. Past shortages have been minimal, but importers should remain vigilant and have contingency plans in place.

1. 1Dual-Sourcing: Engage multiple suppliers to mitigate risks associated with single-source dependency.
2. 2Inventory Planning: Maintain adequate stock levels to buffer against supply chain disruptions.
3. 3Payment Terms: Negotiate favorable terms such as Letters of Credit (LC), Documents Against Acceptance (DA), or Documents Against Payment (DP) to manage financial risks.
4. 4Supplier Qualification: Conduct thorough due diligence to ensure suppliers meet quality and regulatory standards.
5. 5Regulatory Compliance: Stay updated on import regulations and ensure all necessary documentation is in place to avoid customs delays.

1. 1DGFT Importer-Exporter Code (IEC): Obtain an IEC from the Directorate General of Foreign Trade.
2. 2CDSCO Registration: Submit Form 40/41 to CDSCO for product registration.
3. 3Drug Import License: Apply for a license under the Drugs and Cosmetics Act.
4. 4No Objection Certificate (NOC): If applicable, obtain an NOC from the Ministry of Health.
5. 5Customs Broker: Engage a licensed customs broker for clearance procedures.
6. 6Advance Ruling: Seek an advance ruling for HS Code 30021500 to confirm classification and duty rates.

1. 1Certificate of Analysis (CoA): Demonstrates product quality and compliance.
2. 2Certificate of Pharmaceutical Product (CoPP): Confirms product registration in the country of origin.