Drug licence forms 20, 21, 20B and 21B explained

Last reviewed: · Pharma Mithra

A chemist's licence certificate usually carries a string of form numbers — 20, 21, 20B, 21B — and buyers often treat them as interchangeable. They are not. Each form is a different licence under the Drugs and Cosmetics Rules, 1945, and together they decide whether a firm may sell by retail or wholesale, and which drugs it may sell. This guide explains each one.

The two questions every sale licence answers

Under the Drugs and Cosmetics Act, 1940, selling, stocking, exhibiting or distributing drugs requires a licence from the State Licensing Authority. The Rules split sale licences along two lines:

  • Retail or wholesale. Retail is sale to the patient or consumer, normally against a prescription where one is required. Wholesale is sale to other licensed dealers, hospitals, dispensaries and institutions.
  • Which schedule the drugs fall in. The Rules treat ordinary drugs, the "special" products in Schedules C and C(1), and the high-risk drugs in Schedule X differently.

A business that does both retail and wholesale, across ordinary and Schedule C/C(1) drugs, holds all four of the common licences. That is why so many pharmacy certificates list 20, 21, 20B and 21B together. They are applied for on Form 19 and granted on the forms below.

The forms at a glance

FormSaleDrugs covered
20RetailDrugs other than those in Schedules C, C(1) and X
21RetailDrugs in Schedules C and C(1), excluding Schedule X
20BWholesaleDrugs other than those in Schedules C, C(1) and X
21BWholesaleDrugs in Schedules C and C(1), excluding Schedule X
20ARetail, restrictedOnly the drugs named in the licence, other than Schedules C, C(1) and X
21ARetail, restrictedOnly the Schedule C/C(1) drugs named in the licence, excluding Schedule X
20FRetailDrugs in Schedule X
20GWholesaleDrugs in Schedule X

Form 20 and Form 21: retail sale

Form 20 is the licence to sell, stock, exhibit or offer for sale, or distribute by retail, drugs other than those specified in Schedules C, C(1) and X. Form 21 is the corresponding retail licence for drugs specified in Schedules C and C(1), excluding those in Schedule X.

Retail licences are granted for a pharmacy whose sales are carried on under the supervision of a registered pharmacist, and the licence names that person. The licence must be displayed in a prominent place in the part of the premises open to the public, and a change in the qualified staff in charge must be reported to the licensing authority within a month.

A retail licence does not permit wholesale. A pharmacy holding only Forms 20 and 21 should not be supplying stock to other pharmacies or to hospitals as a wholesaler.

Form 20B and Form 21B: wholesale sale

Form 20B licenses wholesale sale and distribution of drugs other than those in Schedules C, C(1) and X. Form 21B licenses wholesale sale and distribution of Schedule C and C(1) drugs, excluding Schedule X. Distributors, stockists, super-stockists and carrying-and-forwarding agents normally hold both.

A wholesale licence names a competent person in charge, who must meet the qualifications or experience in dealing with drugs that the Rules set out; this need not be a registered pharmacist. If you are a pharmacy or a hospital, the supplier you buy from should hold a wholesale licence, and the form must match the product: a distributor with Form 20B but no Form 21B should not be supplying you vaccines or insulin.

Forms 20A and 21A: restricted licences

Restricted licences are retail licences for dealers who do not employ a registered pharmacist — typically general stores or vendors in places where no regular pharmacy is available. They are applied for on Form 19A. Form 20A covers drugs other than those in Schedules C, C(1) and X, and Form 21A covers drugs in Schedules C and C(1), excluding Schedule X.

The key word is "restricted": the holder may sell only the drugs the licence itself lists, and only by retail. A restricted licence holder is not a pharmacy and cannot act as a wholesaler, so it should never appear as a supplier to another business.

Forms 20F and 20G: Schedule X

Schedule X lists drugs with a high potential for misuse, mostly certain narcotic and psychotropic substances. They cannot be sold on an ordinary 20/21 licence. A separate licence is needed: Form 20F for retail sale and Form 20G for wholesale, applied for on Form 19C.

Schedule X sales also come with stricter conditions on prescriptions and record-keeping than ordinary drugs. Many of these substances are additionally controlled under the Narcotic Drugs and Psychotropic Substances Act, 1985, which has its own requirements. If you buy Schedule X products, your supplier must hold Form 20G and you must hold Form 20F.

Schedule C, C(1) and X in plain words

Schedule C

Biological and special products — for example sera, vaccines, toxins and antitoxins, insulin, and antibiotics and other preparations given by injection. Many of these need controlled storage, often refrigeration, which is one reason the Rules license them separately.

Schedule C(1)

Other special products, including many products of biological origin such as certain hormones, vitamins and antibiotics for oral use, and ophthalmic preparations. In practice, almost any pharmacy or distributor handling a normal range of medicines stocks C and C(1) products, so a "20 only" licence is unusual for a full-line business.

Schedule X

A short list of drugs with high misuse potential, sold only under Forms 20F/20G with additional controls. Schedule X is a licensing category; it is not the same as Schedule H or H1, which are about prescription-only sale and are sold under ordinary licences.

Other forms you may see

  • Forms 20C and 20D are retail and wholesale licences for homoeopathic medicines.
  • Manufacturing licences are a different family altogether (the Form 25 and Form 28 series, among others). A manufacturing licence is about making drugs; if you buy through a manufacturer's depot or a distributor, check that entity's own sale licence.

Which forms should your supplier hold?

  • Buying general medicines for a pharmacy: the supplier needs Form 20B.
  • Buying injectables, vaccines, insulin or other Schedule C/C(1) products: the supplier also needs Form 21B.
  • Buying Schedule X drugs: the supplier needs Form 20G.
  • Supplying a pharmacy: the buyer should hold Forms 20 and 21 (or the wholesale forms, if it is a dealer) for the premises you deliver to.
A form number on a certificate only tells you what was granted. Whether that licence is still in force is a separate question; see how to verify a drug licence and expired or cancelled licences.

Check it with Pharma Mithra

See which licence forms a supplier actually holds, and whether each one is in force, before you buy.

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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.

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