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How To Export Pharmaceuticals From India

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Introduction: Export Pharmaceuticals

When it comes to pharmaceutical industries, India ranks among the fastest-growing nations, and the country has made a name for itself as one of the largest global centers for research and production. The vast majority of pharmaceutical products sold in India are made there and are in high demand. The primary regulatory bodies for the production and export of pharmaceutical products from India are the Director General of Foreign Trade (DGFT), the Drug Controller General of India, and the Pharmaceutical Export Promotion Council of India. Let's explore the pharmaceutical export process for products from India.

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Advantages Of Exporting Pharmaceuticals From India

  • Since the past ten years, the demand for Indian pharmaceutical exports has increased significantly around the globe.
  • Trade agreements with foreign countries for the convenience of doing business aid in the simplicity of the export process.
  • Several initiatives have been taken by the government the ease of doing business and export procedures from India, 
  • India is among one of the top three Pharmaceutical markets in the world.
  • The lowest price range of the domestically manufactured pharmaceuticals products in the world makes it easily reachable to the lowest section of the world and is highly growing 

How To Export Pharma Products Outside India?

The export of pharmaceutical products requires lots of licensing from the different authorities in India. The major roles are played by the Drug Controller General of India (DGCI) and the Director General of Foreign Trade (DGFT), which work under the Ministry of Commerce.

Major Drug Importing Nation From India 

The following are the major countries from which India exports medicines:

  • North America 
  • Asia  (excluding the Middle east)
  • Oceania
  • Africa
  • European Union
  • Asean
  • LAC
  • CIS
  • Middle east
  • Other European nations 
  • Other American countries 
  • South Asia

What Are The Categories Of Exportable Pharmaceutical Products In India?

  • Drugs formulations and biologicals.
  • Bulk drugs and drug intermediates 
  • Ayush and Herbals Products 
  • Surgical goods

What Are The Procedure Involved In The Export Of Pharma Products Outside India?

The applicant who wishes to export pharmaceutical products from India must obtain mandatory licenses, which entails the following steps:

  • Get the registration of your company with the Drug Controller General of India (DCGI), DCGI is the governing body of the Central drugs Standard Control Organization (CDSCO) under the Drug and Cosmetics Act, 1940, 
  • GMP certification, it goes through the review of the products to be sold out of India, this is one of the mandatory certification for the manufacturing and selling of pharmaceutical products. 
  • Get the registration done of your Company with the DGFT, the procedure for the same is:
  1. Visit to the DGFT official website.
  2. Select the IEC form from the online application tab.
  3. Fill the IEC registration application 
  4. Enter the PAN card number and login to the application.
  5. Choose the file and fill the IEC application details.
  6. Fill the application and click on the ‘upload documents’
  7. Upload the documents in the application.
  8. Fill the branch details.
  9. Fill the details of the directors.
  10. Make the payment of the online application form.

Documents required for the Import Export certificate number 

  • PAN details of the Company.
  • Bank account details of the Company
  • Bankers certificate
  • IEC code number of the fee paid
  • The submission of the hard copy of the documents submitted along with DGFT RLA concerned within 15 days of the filling of the application.

Read Our Blog: GMP Consultants for Pharmaceutical Products in India

What Are The Documents Required For The Export Of Pharma Products Manufactured In India?

For the export of pharmaceutical products outside of India, there are several documents and grants of licenses required for the same. These documents are:

  • Grant of IEC (import export number) number.
  • Contracting with the country who are intended to import medicines from India.
  • Registration of the product in the country of export
  • Export approval from DCGI (Drug Controller General of India)
  • Confirmation of the shipping method (before the exporting medicines from India) or find out the Supplier, trader, exporter of the pharmaceutical products.
  • The purchase order and preform invoice with the details like type of packing, goods details, rate of products etc.
  • Commercial invoice against letter of credit or purchase order 
  • Signing of the contract with the shipping company (or agent) for the shipment of the goods to the destination.
  • The custom clearance is mandatory for the export of the goods from India to the destined nation. 
  • Obtaining the customs clearance from the importing nation as well.
  • After obtaining all the above mentioned documents, the specified pharmaceutical products are ready for export from India.

What Are The Documents Required For The Export Of Pharmaceutical Products Outside India?

There are more than 10 documents required for the export of goods outside India. These are:

  • Incorporation certificate of the Company
  • IEC number of the Goods 
  • HS Code of the product
  • Ownership certificate of the premises 
  • GMP certification of the product
  • Certificate of Origin 
  • Bill of lading 
  • Bill of exchange
  • Commercial invoice providing a list of details of the goods to be exported and charges thereof etc. 
  • Letter of credit (issued by the Company’s bank for the acceptance of the amount.)
  • Destination Control statement
  • Electronic export information (EEI)
  • Export license

Conclusion

One of the most essential needs is healthcare, and as the world's population rises, so does the importance of pharmaceutical and healthcare products. India is one of the major global suppliers of generic medications and its pharmaceutical products are in high demand worldwide.

The Indian pharmaceutical industry is one of the biggest research centers in the world. Consult with a Corpseed export specialist today for more details and help with the licensing system and export process from India.

DGFT License

Corpseed will be liaising partners for your import/export license requirement and policy/procedures. We can handhold you through the complete licensing formalities with the Director General Foreign Trade (DGFT).

Import Export Code

IEC (Import Export Code) license is mandatory certificate to get before starting any business related to import or export of goods from one country to another. Apply for IEC Code to avoid any penalties from port authorities. No Hidden Fees.

Certificate of Pharmaceutical Products

The Certificate of a Pharmaceutical Product is needed by the importing country when the product in question is intended for registration (licensing, authorization) or renewal of registration, with the scope of commercialization or distribution in that country.

This portion of the site is for informational purposes only. The content is not legal advice. The statements and opinions are the expression of author, not corpseed, and have not been evaluated by corpseed for accuracy, completeness, or changes in the law.

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Author
Ravikant Rai
Hi, I am Ravikant Rai, a Technology Lawyer, who graduated with B. A. LL. B. (Hons.) from the school of law and legal affairs at Noida International University I have two years of experience writing about law as a freelancer and aspiring lawyer. In addition, I have experience writing, Content creation and researching legal information. Various articles on business and corporate law, cyber law and cyber security have been authored by me. I currently work in technology deals, corporate, fintech, and cyber law, etc. I have written documents on a variety of subjects, including software licensing, license to use, terms of service, privacy policy, cloud computing service, data security, confidentiality, and data protection, as well as shareholder and founder requirements.

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