By Team Metacorp on November 28, 2023

Documents Required To Start Pharmaceutical Medicine Export Business in India


Documents Required To Start Pharmaceutical Medicine Export Business in India: The Indian Pharmaceutical Business revenue over the last two decades has grown rapidly. The country has made a name for itself as one of the largest global centers for research and production. The vast majority of medicines sold in India are manufactured there and are in high demand. 


As a consequence of the high demand for pharma products, the foreign trade of pharmaceutical products experienced a substantial boom. Starting a Pharmaceutical business in India complying with several regulations and obtaining compulsory licenses and permits. Multifarious Documents Required To Start Pharmaceutical Medicine Export Business in India, here is a general list of what you may need to start a pharma business in the industry.

Business Registration

Business registration is a foundational aspect of an entity looking to operate legally and establish itself as a legitimate pharma export business. The importance of business registration spans several aspects of credibility, financial transactions, legal compliance, and overall business operations.

  • Certificate of Incorporation: Proof of the legal existence of your company.
  • Memorandum and Articles of Association: Details about the company's objectives and internal regulations.
  • PAN Card and TAN: Permanent Account Number and Tax Deduction and Collection Account Number for taxation purposes.

Drug License

It is a legal document that is issued by the regulatory authorities. It is vital for the pharmaceutical industry that offer complete public safety, quality assurance, regulatory oversights, traceability, control of drug distribution, and International trade freedom. 

  • Wholesale Drug License: Obtained from the State Drugs Control Department, authorizing the wholesale distribution of pharmaceuticals.
  • Retail Drug LicenseIf applicable, depending on your business structure.

Goods and Service Tax (GST) Registration

GST is one of the necessary Documents Required To Start a Pharmaceutical Medicine Export Business in India, including other countries.GST is like a comprehensive indirect tax that has replaced several indirect taxes.

  • GST Registration Certificate: Mandatory for businesses involved in the supply of goods and services.
  • IEC (Import Export Code): IEC Certificate: Required for engaging in the import and export of goods and services.

Quality Management Certifications  

In the pharma business, you never negotiate the quality of products. Quality management certifications are commitment to quality, and building trust among customers, partners, and stakeholders. It is an internationally recognized standard that an organization can achieve to demonstrate commitment.

  • ISO Certification: Demonstrates adherence to international quality management standards.
  • GMP Certification: It is issued by several regulatory authorities.
  • SA8000:  It is focused on Social Accountability at the International level.

Pharmaceutical Product Registration

Pharmaceutical Registration is a complicated procedure that needs collaboration between pharmaceutical companies and regulatory authorities to ensure that patients have safe and effective medicines.

  • Free Sale Certificate (FSC): Required for exporting pharmaceutical products. Issued by the regulatory authority.
  • Certificate of Pharmaceutical Product (COPP): Issued by the Drug Controller General of India (DCGI) after product registration.

Transportation and Logistics Documents

Transportation and logistics include the movement of pharma products from one location to another. Several documents are used to facilitate and manage this procedure that ensures that pharma product shipments are accurately documented.

  • Bill of Lading/Airway Bill: For shipping goods internationally.
  • Packing List: Details of the contents of each package.
  • Commercial Invoice: Provides details about the products, quantity, and value.

Export Contracts and Agreements 

The export Contract agreement is one of the Documents Required To Start a Pharmaceutical Medicine Export Business in India. It is a legal contract specifying terms and conditions between the exporter and importer in the context of International trade. 

  •  Legal Protection 
  • Clarity and avoidance of disputes
  • Risk Mitigation 
  • International Recognition 

Other Documents Required To Start Pharmaceutical Medicine Export Business in India

The export of pharmaceutical products requires a lot of licensing and certificates from the different authorities in India. Below we mentioned some Documents Required To Start a Pharmaceutical Medicine Export Business in India:

  • Environmental Clearance Certificate: Depending on the nature of the pharmaceutical business.
  • Marine Insurance Certificate: If applicable, to cover risks during transportation
  • Phytosanitary Certificate issued by the Plant Quarantine Authority.
  • Certificate of Origin that is Issued by Chamber of Commerce:** Confirms the origin of the goods.
  • Country-specific documentation is an additional documentation that depends on the importing country, you may need specific documents as per their regulatory requirements.
  • Letter of Credit (if applicable), A financial document ensuring payment to the exporter.
  • Customs Declaration Forms are Required for clearing customs in both the exporting and importing countries.
  • A Trademark Certificate is used to protect the company's brand identity.

What Are the Advantages of Starting a Pharmaceutical Medicine Export Business in India?

Pharma is a very vast area and joining the pharma industry offers you high-margin profit with high returns. It provides multifarious advantages:

  • The demand for Indian pharmaceutical exporters has increased around the globe. 
  • Trade agreements with foreign countries for the convenience of doing business help in the simplicity of the export business.
  • Various initiatives have been taken by the government to ease of doing pharmaceutical export business procedures from India.
  • India is one of the top three pharmaceutical markets in the world.
  • The cost-effective drugs manufactured in India. 

Some Important Tips

Mostly we see pharma experts confused about how to export their products, to help you out we mentioned some important tips to run your pharma business smoothly in the international level:

  • Engage legal and regulatory consultants to ensure compliance with all applicable laws and regulations.
  • Keep abreast of changes in export-import policies and regulations.
  • Maintain accurate records of all transactions and documentation for auditing purposes.
  • Always check with the relevant authorities and legal professionals to ensure that you have the most current and accurate information for your specific circumstances.
  • Compliance with all regulatory requirements is essential.


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