Procedure for Export of Pharmaceutical Products from India

India exports pharmaceutical products to over 200 nations and is ranked among the top 3 global producers of drugs by volume. However, for a consignment of tablets, injectables or bulk drugs to travel from the warehouse to shelf, from an Indian production floor to an international pharmacy requires not just a quality product but also needs to follow a specific process of licenses, inspections and documentation.

Here is a step-by-step guide to the process of exporting medicines from India so that novice exporters are well-informed of what to expect and buyers know what to look for before placing an order from reliable pharmaceutical exporters in India.

Why This Procedure Matters

Pharma exports have direct implications on health so there are stricter regulations around pharmaceutical trade than most other products. One break in the supply chain and your goods can be delayed in customs, refused at the port of destination, or risk patients’ lives. The Central Drugs Standard Control Organisation (CDSCO), Pharmaceuticals Export Promotion Council of India (Pharmexcil) and Directorate General of Foreign Trade (DGFT) all regulate this sensitive industry.

Step-by-Step Procedure to Export Pharmaceutical Products from India

Step 1: Get an Import Export Code (IEC)

No export of any kind can happen from India without an IEC, issued by the DGFT. Apply online with your PAN, bank details, and a cancelled cheque. This code acts as your identity for every cross-border shipment you make going forward.

Step 2: Hold a Valid Drug Manufacturing or Wholesale License

If you manufacture the product, you need a license under Form 25 or Form 28 from your State Licensing Authority. If you trade in finished drugs without manufacturing them, a wholesale drug license under the Drugs and Cosmetics Act applies instead.

Step 3: Register with Pharmexcil for an RCMC

Pharmexcil issues the Registration-cum-Membership Certificate that most pharma exporters need before they can ship. Apply on the Pharmexcil portal with your IEC, manufacturing license, and company registration papers. The certificate stays valid for five years.

Step 4: Get an Export NOC from CDSCO

For new, unapproved, or banned drugs meant only for the export market, you need a No Objection Certificate from CDSCO or your State Licensing Authority. Apply at the relevant CDSCO zonal office with your manufacturing license, product details, and an undertaking that the batch will not be sold within India.

Step 5: Check the Destination Country’s Rules

Many countries want their own product registration or market authorization before a drug can enter. This can mean an ANDA filing for the US, a Certificate of Pharmaceutical Product (CoPP) for several other markets, or a full dossier review under that country’s drug authority. Skipping this step is one of the most common reasons shipments get stuck.

Step 6: Prepare Quality and Batch Documents

Every batch needs a Certificate of Analysis matching the specifications the buyer’s country expects. For active pharmaceutical ingredients, a Drug Master File often needs to sit on file with the importing country’s regulator. Stability data and shelf-life reports round out what most buyers will ask for.

Step 7: Pack and Label as Per the Buyer’s Market

Labeling rules differ by country, covering everything from language requirements to batch numbers, expiry dates, and storage instructions. Cold chain products and agricultural food processed products need extra care here, with temperature logging built into the packaging for the full transit.

Step 8: Prepare Export Documentation

Standard shipping papers apply on top of the pharma-specific ones:

• Commercial invoice and packing list
• Bill of lading or airway bill
• Certificate of origin
• Insurance certificate
• Letter of credit, where the deal is structured that way

Step 9: Customs Clearance and Shipping

Pharmaceuticals move under HS Code 30 at Indian customs. Choose a shipping method, air for time-sensitive or high-value goods, sea for bulk shipments, based on the product and the buyer’s timeline. A customs house agent can help clear the paperwork at the port quickly.

Step 10: File Post-Export Compliance Reports

For products shipped under an Export NOC, CDSCO expects the exporter to report the quantity actually shipped through its online reconciliation system. Keeping this updated avoids trouble on future NOC applications.

Documents Checklist at a Glance

How Long Does the Whole Process Take?

Timelines vary by product and destination, but a rough picture looks like this:

• IEC registration: usually 1 to 2 working days once the online form is submitted
• Pharmexcil RCMC: about 1 to 2 weeks after documents are checked
• CDSCO Export NOC (where needed): typically 2 to 6 weeks, depending on the product and whether an inspection is called for
• Destination country registration: this varies the most, running from a few weeks for simple markets to well over a year for a full US or EU filing on a new product

A first shipment to a new market can take several months from start to finish once every registration is in place. Repeat shipments of an already-registered product move far faster, often within days of the order being confirmed, since most of the paperwork carries over from one consignment to the next.

Common Mistakes Exporters Make

• Shipping a new or unapproved drug without securing the CDSCO Export NOC first
• Missing destination-country registration, especially in the US and EU
• Using packaging or labels that do not match the buyer’s language or storage rules
• Letting the RCMC or manufacturing license lapse mid-shipment cycle
• Skipping cold chain checks for temperature-sensitive drugs, leading to rejected batches at the port of arrival

Working With a Trade Partner for Pharma Exports

Managing all of the above ten steps in addition to operating a manufacturing facility is overwhelming for any one team. That is where a trade partner can assist. Srindhya Global exports GMP certified pharma products ranging from finished formulations to APIs and bulk drugs to institutional buyers and distributors overseas with all the compliance documentation already prepared for each shipment. Buyers who wish to source from India have a single point of contact to handle supplier audits, documentation and freight instead of pursuing multiple parties for the same purchase order.

Srindhya Global trades in agricultural and food products, chemicals, and marble, granite and wooden products for buyers who require more than one product category from an Indian supplier.

Wrapping Up

Exporting pharmaceutical products from India can be streamlined into five steps: IEC, manufacturer/wholesaler license, Pharmexcil RCMC, CDSCO clearance (if applicable), then shipping and Customs as usual. Slip one process and a container can be at your port for weeks. Follow each process correctly and pharmaceutical products made in India successfully reach their buyers in over 200 countries each year. Partnering with a knowledgeable local source in India can alleviate much of the burden on the buyer.