Exporting Medicines from India: A Step-by-Step Guide

A synopsis of the Indian Pharmaceutical Sector

An important factor in the expansion of the Indian economy is the pharmaceutical sector. The pharmaceutical industry consists of contract research, biopharmaceutical, non-prescription, generic, and branded enterprises. India exported $20.27 billion worth of medicines in 2022, and by 2025, it was projected to have grown at a rate of thirty percent, or $20 billion.

The Indian pharmaceutical sector ranks third in terms of volume and tenth in terms of value. It has become known as a major international hub for research and production.

The sector has a distinct edge due to its highly skilled personnel and extensive supply of raw materials. It was projected that the Indian pharmaceutical industry will grow at a Compound Annual Growth Rate (CAGR) of 22.4% by 2025, when it would be valued US$ 55 billion.

Over-the-counter (OTC) medications and patented treatments make up 21% and 9% of the Indian pharmaceuticals business, respectively, with generic drugs controlling 70% of the market.

In order to encourage companies to produce pharmaceutical components domestically, India plans to establish a fund of around Rs 1 lakh crore (US$ 1.3 billion) by 2026.

Are you looking for help exporting Indian medicines? Speak with one of our import export consulting specialists today to receive a comprehensive solution!

Advantage India (Data on Medical Exports) and India Pharma Exports

• India is one of the top exporters of generic pharmaceuticals to the globe, accounting for 20–22% of total export volume.
• In FY23, the total value of medications and pharmaceuticals exported was US$ 24.44 billion, and in March 2023, it was US$ 2.30 billion.
• Bulk intermediates worth US$ 1.37 billion were exported by Indian pharmaceutical exporters between April and August of 2021.
• India’s bulk medicine and drug intermediate exports were valued at US$ 4.43 billion in FY23 compared to US$ 3.89 billion in FY22.
• Exports of drugs and pharmaceuticals valued at US$ 1.97 billion in August 2022 surpassed US$ 2.0 billion in August 2023.
• India has some of the most affordable manufacturing rates globally. The comparison is less than that of nearly half of Europe and the United States.

The Complete List of Medicines Shipped Out of India: Unlocked Medical Exports from India

The list of medicines that India has exported during the previous three years is shown below. The export of pharmaceuticals and medications from India has increased to 7.59%, as can be shown.

List of the drugs that India exports the most

1. Biologicals and medication formulations: an 11.27% increase
2. Drug intermediates and bulk drugs: (-0.32% increase)
3. Operations: (-21.32% increase)
4. Herbal and Ayush Products: (-4.04% increase)

List of Documents Needed to Ship Pharmaceuticals Overseas

In order to export medications from India, the following paperwork is needed:

1. Business PAN number
2. The Certificate of Incorporation
3. Financial papers such as bank account statements
4. Indian Trade Classification System (HS) for the item
5. Customs paperwork, including Bankers Certificates, 
6. IEC Number 
7. Cancelled cheque
8. Evidence of company property ownership or a signed leasing agreement  
9. WHO: Certificate of GMP

Information should be mandatory in the above-mentioned documents: 

1. Details of the product
2. authorised generic names
3. potency for each dose 
4. Dosage configuration
5. Information about the package
6. A list of every active component in pharmaceuticals along with its qualities 
7. graphical explanation 
8. List of nations in which the product has been accepted, refused, and removed 
9. Locations of production and synthesis technique
10. Examination of stability
11. The safety and effectiveness

A comprehensive guide on exporting medications from India

If your Indian pharmaceutical business is registered, exporting generic medications is a simple process. For hassle-free drug export from India, adhere to these measures.

1. The IEC (Import Export Code) number application process is the initial stage in exporting medicines from India.
2. Make an agreement with exporters from other nations that are considering bringing the medication into the country.
3. In the nation where you plan to export your goods, register your product.
4. Obtain the DCGI’s (Drug Controller General of India) clearance before exporting any medications.
5. Before exporting pharmaceuticals from India, you must choose a transportation method. Alternatively, you can choose a pharmaceutical trader, exporter, and supplier.
6. After receiving the purchase order from the firm importing the drugs from India, submit a proforma invoice that contains details about the goods, including the kind of packaging, the price, the freight cost, etc.
7. Create a business invoice based on a purchase order or letter of credit.
8. Appoint a freight forwarding business to arrange for the cargo to be sent to the right nation.
9. You will have to go through customs clearance after finishing all of the paperwork. Alternatively, if you would want to save time, you can complete this on your own with the assistance of an agent.
10. When they have been cleared, the pharmaceuticals will be shipped to the nation of import.
11. Clearance through customs is also necessary at the country of import.

Important Information to Know Before Exporting Generic Medicines from India

Indian pharmaceutical manufacturers that wish to export their products should take into account the following process for exporting medicines, including generic medications:

1. The process for registering a product in a foreign nation,
2. The legal and compliance requirements of the importing nation,
3. More certificates might be required by the importing nation,
4. Distributors, merchants, and potential purchasers in the importing nation are found using this approach (registration).
5. Establishing a productive supply chain structure in the importing nation
6. Procedures for clearing customs.
7. Exporting generic medications from India requires approval from the Drug Controller General.