Importing Medicaments from India to the USA: A Comprehensive Guide

Importing Medicaments from India to the USA:

Legal Framework and FDA Regulations:

In the USA, the Food and Drug Administration (FDA) oversees the importation of pharmaceuticals to ensure safety, efficacy, and compliance with federal regulations. Importing medicaments for personal use or commercial purposes involves strict adherence to the following guidelines:

• Personal Importation:

  The FDA allows individuals to import a 90-day supply of medicaments for personal use under specific conditions. These include:

  • The product is for a serious condition with no effective treatment available domestically.

  • It is not promoted or sold to U.S. residents commercially.

  • The quantity does not exceed a three-month supply.

  • A written affirmation from a U.S.-licensed physician and documentation (e.g., a prescription) are required.

  • The medicament must not pose an unreasonable health risk and should ideally be FDA-approved or equivalent in the foreign country.

• Commercial Importation:

  For businesses, the FDA’s Section 804 Importation Program (SIP) allows states or tribes to develop programs to import FDA-approved prescription drugs from countries like India, provided they meet safety standards. Manufacturers must register with the FDA, submit a Structured Product Labeling (SPL) document, and provide a U.S. agent’s details.

• Customs Clearance:

  Upon arrival, U.S. Customs and Border Protection (CBP) inspects shipments. Required documentation includes a commercial invoice, certificate of origin, and, for controlled substances, coordination with the Drug Enforcement Agency (DEA). Misbranded or unapproved drugs may be detained or seized.

• Additional Considerations:

  Medicaments must comply with labeling requirements (e.g., accurate dosage instructions) and be free from contamination. Temperature-controlled shipping may be necessary for certain products.

For more details, visit the FDA’s official guidance on Human Drug Imports.

Export Procedures in India for Medicaments to the USA

Regulatory Requirements:

India, often dubbed the "Pharmacy of the World," has a robust framework for exporting medicaments. The process involves obtaining necessary licenses and adhering to international standards:

• Business and Licensing:

  The pharmaceutical company must be registered with the Registrar of Companies and hold a manufacturing license from the Central Drugs Standard Control Organisation (CDSCO). Membership in the Pharmaceutical Export Promotion Council (Pharmexcil) and a Registration-cum-Membership Certificate (RCMC) from the Directorate General of Foreign Trade (DGFT) are also required.

• Import-Export Code (IEC):

  An IEC number, obtainable from the DGFT portal, is mandatory for all export activities. The application involves a processing fee of INR 250 and submission of supporting documents within 15 days.

• Product Approval:

  The medicaments must be approved by the CDSCO, and a Certificate of Pharmaceutical Product (CPP) is required for export. Compliance with Good Manufacturing Practices (GMP) is essential.

• Documentation:

  • Business registration and GST details.

  • Free Sale Certificate.

  • Commercial invoice and proforma invoice detailing packing, rates, and freight.

  • Customs clearance certificate.

• Export Process:

  1. Conduct market research to identify U.S. demand and connect with importers.

  2. Register the product with the U.S. FDA and obtain approval.

  3. Receive a purchase order from the U.S. importer and sign a contract with a freight forwarder.

  4. Complete customs clearance in India, followed by shipping and clearance in the USA.

Reputable courier services like DHL Medical Express or Anytime Express can assist with documentation and temperature-controlled logistics, ensuring compliance with International Air Transport Association (IATA) regulations.

Key Steps for US Import:

1. FDA Establishment Registration:

• What it is: Every foreign establishment involved in the manufacturing, preparation, or processing of a drug for the US market must register with the FDA. This registration must be renewed annually.

• How it's done: Registration is done electronically through the FDA's FURLS (FDA Unified Registration and Listing System).

• U.S. Agent: A crucial part of this process is designating a U.S. Agent. This person or entity must reside or maintain a place of business in the USA and acts as the primary point of contact between the FDA and your company.

2. Drug Listing:

• Alongside facility registration, you must "list" every drug product you intend to market in the USA.

• This involves submitting detailed information about the product, including its National Drug Code (NDC), active ingredients, labeling, and packaging. This is also done electronically.

3. The Drug Approval Application (NDA / ANDA):

• This is the most critical step. No drug can be legally marketed in the US without prior FDA approval.

• New Drug Application (NDA): This path is for new, innovative drugs that have not been previously approved. It requires extensive data from clinical trials to prove the drug is both safe and effective for its intended use.

• Abbreviated New Drug Application (ANDA): This is the pathway for generic drugs. Instead of new clinical trials, an ANDA must scientifically demonstrate that the generic product is bioequivalent to a previously FDA-approved brand-name drug (the "reference listed drug").

4. Adherence to Current Good Manufacturing Practices (cGMP):

• It's not enough to have an approved drug; your manufacturing facility must comply with US cGMP regulations (found in Title 21 of the Code of Federal Regulations, Parts 210 and 211).

• The FDA has the authority to inspect foreign manufacturing sites to ensure cGMP compliance. A failed inspection can result in an "Import Alert," effectively banning your products from entering the US.

5. Labeling and Packaging:

• FDA regulations for drug labeling are notoriously strict. All text must be in English and must include precise information such as the drug's name, net quantity, ingredients, dosage instructions, expiration date, and the manufacturer's details.

• The packaging must also comply with the Drug Supply Chain Security Act (DSCSA), which requires unique product identifiers for tracking and tracing products throughout the supply chain.

6. The Shipment and Customs Process:

• When your shipment arrives at a US port, the U.S. Customs and Border Protection (CBP) works with the FDA to clear it.

• The importer files entry documents with CBP, which then refers the shipment to the FDA for review.

• The FDA uses an automated screening tool called PREDICT to assess the risk of each shipment. Based on this, the shipment may be immediately released ("May Proceed") or be detained for a physical examination or sampling. If the product appears to violate any regulations, it will be refused entry.

Key Steps for Export from India:

On the Indian side, the primary regulatory bodies are the Central Drugs Standard Control Organization (CDSCO) and the Directorate General of Foreign Trade (DGFT).

1. Valid Manufacturing License:

• First and foremost, your company must possess a valid drug manufacturing license issued by the relevant State Drug Control Administration and approved by the CDSCO.

2. Importer-Exporter Code (IEC):

• The IEC is a mandatory 10-digit code issued by the DGFT. No company can engage in import or export activities in India without obtaining this code.

3. Export No Objection Certificate (NOC) / Permission:

• For exporting drugs, manufacturers often need to obtain an export NOC from their respective Zonal/Sub-zonal office of the CDSCO.

• The application typically requires submitting a copy of the purchase order from the US importer, the manufacturing license, and a list of the products to be exported.

4. Certificate of Pharmaceutical Product (CoPP):

• This is a highly important document. A CoPP is issued by the CDSCO in the format recommended by the World Health Organization (WHO).

• It certifies that the drug product is approved for sale in India and that the manufacturing facility is subject to regular inspections and complies with WHO GMP standards. The US FDA often considers the CoPP during its review process.

5. Preparing Export Documentation:

• Meticulous documentation is non-negotiable. Your shipping consignment must be accompanied by:

  • Commercial Invoice and Packing List

  • Bill of Lading (for sea freight) or Airway Bill (for air freight)

  • Shipping Bill: This is the key document filed with Indian customs through the ICEGATE portal.

  • Certificate of Origin

  • Relevant NOC and CoPP

6. Indian Customs Clearance:

• After filing the Shipping Bill, the goods and documents are verified by customs officials. The customs system performs a risk assessment.

• Once customs is satisfied that all regulations have been met, they will issue a "Let Export" order, and the goods can be loaded onto the vessel or aircraft for their journey to the USA.

For further guidance, explore resources on the DGFT website or Shiprocket X.

Practical Tips for Success

• Packaging: Use tamper-evident, temperature-controlled packaging to maintain product integrity.

• Training: Ensure staff are trained in handling and documenting medicaments.

• Partnerships: Collaborate with reliable logistics providers experienced in pharmaceutical shipping.

• Compliance: Regularly audit inventory to manage expiration dates and adhere to FIFO/FEFO protocols.

Conclusion:

Importing medicaments from India to the USA and exporting them from India involves navigating complex regulatory landscapes. By adhering to FDA and CDSCO guidelines, securing proper documentation, and partnering with trusted logistics providers, businesses and individuals can ensure a seamless process. For the latest updates and detailed procedures, refer to the PHARMEXCIL website or consult with trade experts.