Who Supplies Paracetamol to India from HUNGARY

To import finished pharmaceutical formulations containing Paracetamol into India, the following regulatory approvals are required:

1. 1Import License: Obtain an Importer Exporter Code (IEC) from the Directorate General of Foreign Trade (DGFT).
2. 2Drug Registration: Register the product with the Central Drugs Standard Control Organisation (CDSCO) by submitting Form 40/41, along with necessary documents such as the Certificate of Pharmaceutical Product (CoPP), Good Manufacturing Practice (GMP) certificate, and stability data.
3. 3No Objection Certificate (NOC): If the product is already marketed in India, an NOC from the manufacturer may be required.

The registration process typically takes 6–12 months, depending on the completeness of the application and the regulatory workload.

Imported Paracetamol formulations must undergo quality testing at CDSCO-approved laboratories. Each batch requires a Certificate of Analysis (CoA) confirming compliance with Indian Pharmacopoeia standards. Stability studies should be conducted under ICH Zone IV conditions to ensure product efficacy and safety. Customs drug inspectors perform port inspections to verify compliance with regulatory standards. Batch-wise testing is mandatory to maintain quality assurance.

As of April 2020, the DGFT lifted export restrictions on Paracetamol formulations, including fixed-dose combinations, while maintaining restrictions on the export of Paracetamol APIs. This policy change may influence import dynamics, potentially increasing the availability of Paracetamol formulations in the Indian market.

India imports finished Paracetamol formulations to meet domestic demand for various dosage forms, including tablets, capsules, syrups, and injections. The need for imported formulations arises due to factors such as patented or branded products not manufactured locally, specific dosage forms, and quality considerations. The Indian market for Paracetamol formulations is substantial, with a total export market valued at $357.3 million across 870 exporters to 170 countries.

The import duty structure for Paracetamol formulations under HS Code 30049069 is as follows:

• Basic Customs Duty (BCD): 10%
• Social Welfare Surcharge (SWS): 10% of BCD
• Integrated Goods and Services Tax (IGST): 12%

The total landed duty is approximately 23.536%.

Hungary's pharmaceutical industry, particularly Teva Pharmaceutical Works Private Limited Company, offers high-quality Paracetamol formulations. India sources from Hungary due to competitive advantages such as patented formulations, specialized dosage forms, and adherence to international quality standards. Other suppliers include China, Germany, and the United States, but Hungary's unique offerings and quality compliance make it a preferred choice.

India imports Paracetamol formulations from Hungary due to the availability of patented formulations, specialized dosage forms, and high-quality manufacturing standards. Hungary supplies specific formulations that are not manufactured domestically, fulfilling market demands for diverse Paracetamol products.

Compared to other origins like China, Germany, and the United States, Hungary offers competitive pricing, superior quality, and compliance with international regulatory standards. Hungary's unique advantage lies in its ability to provide specialized Paracetamol formulations that meet specific therapeutic needs, setting it apart from other suppliers.

Potential risks include single-source dependency, currency fluctuations, regulatory changes, quality control issues, and shipping disruptions. There have been no significant shortages reported in the past; however, importers should monitor these factors to mitigate potential risks.

1. 1Dual-Sourcing: Engage multiple suppliers to reduce dependency on a single source.
2. 2Inventory Planning: Maintain optimal inventory 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).
4. 4Minimum Order Quantities (MOQs): Align procurement volumes with market demand to optimize costs.
5. 5Supplier Qualification: Conduct thorough due diligence to ensure supplier reliability and compliance with quality standards.

1. 1DGFT IEC: Obtain an Importer Exporter Code from the Directorate General of Foreign Trade.
2. 2CDSCO Form 40/41: Submit the application for drug registration with the Central Drugs Standard Control Organisation.
3. 3Drug Import License: Secure the necessary license for importing pharmaceutical products.
4. 4NOC: If applicable, obtain a No Objection Certificate from the manufacturer.
5. 5Customs Broker: Engage a licensed customs broker to facilitate import procedures.
6. 6Advance Ruling: Seek an advance ruling for HS Code 30049069 to confirm classification and duty rates.

1. 1Certificate of Analysis (CoA): Confirming product quality and compliance with specifications.
2. 2Certificate of Pharmaceutical Product (CoPP): Indicating GMP compliance and market authorization.
3. 3GMP Certificate: Demonstrating adherence to Good Manufacturing Practices.
4. 4Drug Master File (DMF): Providing detailed information on the manufacturing process.
5. 5Stability Data: Conducted under ICH Zone IVa/IVb conditions to ensure product stability.
6. 6Free Sale Certificate: Indicating that the product is freely sold in the country of origin.
7. 7Manufacturer Authorization: Authorizing the exporter to act on