How to verify a drug licence in India

Last reviewed: · Pharma Mithra

Before you place a first order with a new distributor, or supply a new pharmacy on credit, you should know that the other party actually holds a valid drug licence. This guide explains why the check matters, who issues drug licences in India, and exactly what to look at, step by step.

Why verify a drug licence at all

In India, nobody may sell, stock, exhibit for sale or distribute medicines without a licence issued under the Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945. The rule cuts both ways. Your own sale licence carries a condition that you buy drugs only from a duly licensed manufacturer or a duly licensed dealer, against a cash or credit memo. If you buy from a party whose licence is forged, lapsed, suspended or cancelled, you are the one in breach of your licence conditions when an inspector asks where the stock came from.

There is also a practical reason. Unlicensed and improperly licensed traders are the usual route by which spurious, substandard and diverted medicines enter the supply chain. A licence check costs a minute; a batch you cannot trace back to a licensed source can cost you your licence.

A photocopy or a WhatsApp image of a licence certificate is not proof. It shows what the licence said on the day it was issued. It cannot tell you whether the licence has since been suspended or cancelled, whether the firm has changed hands, or whether the document was altered.

Who issues drug licences in India

Drug regulation in India is shared between the States and the Centre, and which office issued a licence depends on what the licence is for.

  • Retail and wholesale sale licences (pharmacies, chemists, stockists, distributors, C&F agents) are issued by the State Licensing Authority — the state's drugs control department, which in some states is called the Drugs Control Administration or the Food and Drug Administration. Each state licenses premises in that state only.
  • Manufacturing licences for most drugs are also granted by the State Licensing Authority of the state where the factory is. For certain categories, such as vaccines, blood products and some other biologicals, the licence is granted with the approval of the Central Licence Approving Authority, the Drugs Controller General of India at the Central Drugs Standard Control Organisation (CDSCO).
  • Import licences and registrations, and approval of new drugs, are handled by CDSCO.

For a pharmacy or hospital buying from a distributor, the licence that matters is almost always the distributor's state-issued wholesale licence. When you buy directly from a manufacturer, check its manufacturing licence and, if it also sells through a depot, the depot's sale licence.

How to verify a drug licence, step by step

  1. Get the licence numbers and the state. Ask the supplier for every drug licence number it holds at the premises that will supply you, and the state that issued them. A wholesaler often holds two numbers (one under Form 20B, one under Form 21B). Number formats differ from state to state and there is no single national format, so always record the state alongside the number.
  2. Check the number against the issuing state's records. The authoritative answer comes from the licensing authority that issued the licence. Many state drugs control departments publish an online search; otherwise their office can confirm a licence. A verification service such as Pharma Mithra does this lookup for you and gives you a dated record of the result.
  3. Match the firm name and the proprietor or partners. The name on the record should be the business you are dealing with — the name on its invoices and its bank account. A licence is granted to a particular firm with a particular constitution; a different firm cannot borrow it.
  4. Match the premises address. A sale licence covers the premises named in it. A supplier dispatching from a different godown or another town needs a licence for that place too.
  5. Check the licence forms against what you are buying. Wholesale supply needs a wholesale licence (Forms 20B and 21B). Schedule C and C(1) products such as vaccines, insulin and many injectables need the "21" series licence, and Schedule X drugs need a separate licence. Our guide to drug licence forms 20, 21, 20B and 21B explains each one.
  6. Check the status and validity. The licence must be in force today: not cancelled, not suspended, and not lapsed for want of renewal or retention fee. See expired, suspended or cancelled licences for what each status means.
  7. Check the GSTIN as well. The GST registration should be active and should belong to the same business as the drug licence. Our GSTIN guide shows how to match the two.
  8. Keep a dated record and re-check. Save what you checked, the answer and the date. Licences can be suspended or cancelled at any time, so re-check regular suppliers periodically and always before a large order.

What to check on the licence

Firm name

The licence is issued in the name of the firm and names its proprietor, partners or directors. Small spelling differences are common, but a completely different name is not a typo. If the firm's constitution changes, for example a partner leaves or the business is sold, the licence conditions require the licensing authority to be told, and the old licence remains valid only for a limited period unless a fresh licence is taken in the new firm's name.

Address

Compare the licensed address with the address on the supplier's invoices, its GST record and the place goods are actually dispatched from.

Licence forms

The form number tells you what the holder may do: retail or wholesale, and which schedules of drugs. A retail-only licence (Forms 20 and 21) does not authorise wholesale supply to another pharmacy.

Validity

Sale licences issued under the current Rules remain in force unless suspended or cancelled, provided the holder pays a licence retention fee every five years. Older licences and some state records still show a "valid up to" date. A date in the past is a reason to ask questions, not automatically proof the licence is dead, but it must be resolved before you buy.

Status

The status on the issuing authority's record — active, suspended, cancelled or surrendered — overrides anything printed on the certificate.

Qualified person

A retail licence names the registered pharmacist in charge; a wholesale licence names a competent person who meets the qualifications or experience the Rules require. You will not usually verify these yourself, but a licence with nobody named is incomplete.

Red flags

  • The supplier sends a certificate image but will not give the licence number in writing.
  • The name on the licence is not the name on the invoice, the GST record or the bank account.
  • Goods are dispatched from an address that is not on any licence.
  • The supplier offers wholesale supply on a retail-only licence.
  • Cold-chain or Schedule C items offered by a firm without a "21" series licence.
  • The licence shows suspended, cancelled or a validity date that has passed.
  • Invoices without the supplier's drug licence numbers, or requests to pay in cash or to a personal account.
  • Prices far below the market for branded products, especially fast-moving ones.
  • A licence certificate where the fonts, seal or signature look pasted in.
If a supplier fails any of these checks, do not place the order until it is resolved in writing. If you believe someone is trading without a valid licence, you can report it to the drugs control department of the state concerned.

Check it with Pharma Mithra

Enter a supplier's drug licence number and its state, and see who holds it, what it covers and whether it is in force.

Start free

This guide is general information about Indian drug and tax law for businesses, not legal advice. Rules and procedures can differ by state; your state drug control department or GST office has the final word on any individual case.

More guides