How to verify a medicine supplier

Falsified and substandard medicines rarely come straight from a factory. They usually enter through an intermediary that nobody checked. A hospital pharmacy, licensed importer or NGO that sources from India can avoid most of that risk with a short set of checks on the company, its licences and the paperwork behind each batch.

This guide covers what a legitimate supplier in India should hold, how to check each item, which product documents to ask for and the warning signs that justify stopping an order. It complements avoiding falsified and substandard medicines, which covers checks on the packs themselves.

What a supplier in India should hold

Indian law separates the right to trade medicines from the right to export them, so a supplier needs several registrations from different authorities. The table lists the core ones for a trading (non-manufacturing) exporter.

The two wholesale forms are defined in the Drugs and Cosmetics Rules 1945. Form 20B excludes Schedules C, C(1) and X, and Form 21B covers Schedules C and C(1) but still excludes Schedule X. A supplier offering biologicals or vaccines on a 20B licence alone deserves a follow-up question.

Sources disagree on whether a pure trading exporter is legally required to hold a drug licence. Port offices, however, ask for it. A July 2026 public notice from the Jawaharlal Nehru Custom House at Nhava Sheva says that when a shipping bill for drugs is filed by an exporter other than the manufacturer, the exporter must produce the relevant documents to the CDSCO port office and obtain its NOC before export. A trading exporter that cannot show a drug licence will struggle to clear goods at that port.

A step-by-step verification process

The checks below take a few hours for a new supplier and less for a repeat one. Record the result of each step with the date and the name of the person who checked it.

1. Collect the legal identity. Ask for the full legal name, registered address, warehouse address, company registration number and a named contact. Every later document should match these details.
2. Request copies of every licence. Ask for the drug licences, IEC, GST certificate and RCMC as PDFs. Check that the names, addresses and validity dates agree with each other.
3. Check the IEC on the DGFT site. The View any IEC form asks for the code and at least the first three characters of the firm name. A code that returns no details, or details for a different firm, is a stop sign.
4. Check the GSTIN. The GST portal's taxpayer search shows the legal name, trade name and registration status. A cancelled or suspended registration should halt the order.
5. Confirm the drug licence. Compare the licence category with the products on offer. Where the copy looks altered or the premises do not match, ask the state drug control department to confirm it.
6. Ask who made the product. A supplier should name the manufacturer and, on request, show how the stock reached it, for example through an invoice from the manufacturer or its authorised distributor.
7. Check the payment details. The bank account on the proforma invoice should be in the supplier's own legal name, held with a bank in India. Confirm any new or changed bank details by phone on a number already on file, not one taken from the email that announced the change.
8. Re-check on a schedule. Repeat the checks at least once a year and whenever the supplier's name, address or bank account changes.

Product-level checks

A genuine company can still ship the wrong product, so each batch needs its own paper trail. The pharma export documents guide explains each document in detail, and the document checklist tool builds a list for a given order.

Batch documents

Ask for the manufacturer's certificate of analysis for the exact batch, showing the batch number, manufacturing date and expiry date. Those details should match the packing list and, on arrival, the packs. A certificate issued on the supplier's letterhead instead of the manufacturer's is weaker evidence.

Certificate of a pharmaceutical product

Many importing regulators ask for a certificate of a pharmaceutical product (COPP). It is the main document of the WHO certification scheme, issued by the regulator of the exporting country for a specific product and manufacturer. The COPP guide explains what it covers and how long it takes.

Regulatory status in India

Ask whether the product is approved in India, a new drug, unapproved for the Indian market or controlled. Products that are not approved in India need a CDSCO export NOC, and controlled drugs need a separate authorisation for each consignment. The Indian export rules guide sets out what each status means for documents and timing.

Cold chain capability

For refrigerated or frozen products, ask how the supplier packs and monitors them, which shippers it uses and whether each shipment travels with a data logger. The cold chain guide lists the questions worth asking.

Warning signs that should stop an order

None of these proves wrongdoing on its own, but each one needs a clear written answer before money moves.

• Licence copies with different names or addresses, or no licence numbers at all.
• A bank account in a personal name, in a third country or in a name that differs from the invoice.
• Refusal to name the manufacturer or to provide a batch certificate of analysis.
• A price far below what the manufacturer's other channels suggest, with no explanation such as short expiry.
• Offers to ship before the destination import permit is issued, or to describe the goods as something else on the shipping documents.
• Offers to send prescription medicines straight to patients in countries where that is not allowed, such as the United States.
• Pressure to pay immediately because stock is said to be about to run out.

What the destination regulator expects from the buyer

Verification is not only good practice. Several destination routes require the importer to hold evidence about the supplier. In the United Kingdom, for example, a licensed importer that notifies the MHRA of an unlicensed medicine import must include evidence of good manufacturing or distribution practice along with the clinical need. The United Kingdom import guide and the guide to importing unlicensed medicines into the UK cover that route.

Other routes, such as Section 21 in South Africa and special access routes in the GCC, put the importing hospital or licensed importer on the hook for what it brings in. A verification file kept for each supplier makes those applications faster and protects the importer if a regulator asks questions later.

Keeping the file current

Licences and certificates expire, companies move premises and bank accounts change. Keep a simple register with each document, its number, the issuing authority, the expiry date and the date it was last checked. Set a reminder a month before each expiry and ask the supplier for the renewed document before the old one lapses.

When a request is ready, the guide to preparing a sourcing request explains what to send so that the supplier can quote accurately, and a request can be started through the request a quote page.