Wholesale drug licence: Form 20B and 21B

What Form 20B and 21B wholesale drug licences cover, who can apply, premises and competent-person rules, documents, fees and the online process, explained for pharma distributors.

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Short answerTo sell medicines wholesale in India you need a drug licence in Form 20B and, for drugs listed in Schedules C and C(1), Form 21B. You apply on Form 19 to your state's drug licensing authority. You need premises of at least 10 square metres with proper storage, and a registered pharmacist or qualified competent person in charge.

What do Form 20B and Form 21B cover?

FormType of saleCovers
20BWholesaleDrugs other than those in Schedules C, C(1) and X
21BWholesaleDrugs in Schedules C and C(1), products that usually need special storage
20 and 21RetailThe same split, for sale from a chemist shop to patients

Most distributors and PCD franchise partners apply for 20B and 21B together, so their range is not limited later. Drugs in Schedule X need a separate licence.

Who can apply?

A proprietor, partnership firm, LLP or company can apply. The applicant does not need to be a pharmacist, but the premises must be in the charge of a competent person. Under Rule 64 of the Drugs and Cosmetics Rules, 1945, that person must be one of these:

  • a registered pharmacist, or
  • someone who has passed matriculation (or equivalent) and has four years' experience in the sale of drugs, or
  • a graduate of a recognised university with one year's experience in dealing with drugs.

What are the premises requirements?

  • Area: the rules set a minimum of 10 square metres for wholesale premises. Some states ask for more when retail and wholesale run from the same premises, so confirm with your state office.
  • Storage: adequate storage that protects the drugs, and a refrigerator if you will stock products that need cold storage.
  • Ownership or rent: proof that you own or have rented the premises.

Which documents are needed?

Lists differ slightly by state. This is the usual set, based on state checklists:

  1. Application in Form 19
  2. Fee challan or online payment receipt
  3. Site plan and layout plan of the premises
  4. Proof of ownership, or a rent agreement with the owner's consent
  5. Photo ID and address proof of the applicant
  6. Qualification and experience certificates of the pharmacist or competent person, with their affidavit and photographs
  7. Affidavit of the applicant (non-conviction and other declarations, in the state's format)
  8. For firms and companies: partnership deed or MOA/AOA, and a resolution or authorisation
  9. Refrigerator purchase bill, if cold storage is needed

How much is the fee?

State checklists commonly ask for ₹3,000 for Forms 20B and 21B together (₹1,500 per form), paid by challan or online. Check the current amount on your state drug controller's website before paying, because states set the payment head and can revise it.

How do I apply?

  1. Register on your state's licensing system. Many states now use the national ONDLS portal at statedrugs.gov.in.
  2. Fill in Form 19, choose wholesale (20B and 21B), and upload the documents.
  3. Pay the fee and submit.
  4. A drugs control officer inspects the premises.
  5. If everything is in order, the licence is granted and you can download it or collect it.

Keep the licence displayed at the premises and keep its validity current. Renewal and retention rules are set by the Drugs Rules and applied by your state, so note the date on your licence.

What does Acrowell Labs ask from a new partner?

Three things: your drug licence, your GST number and your ID. That is all. See the full documents guide.

Frequently asked questions

Can a non-pharmacist get a wholesale drug licence?
Yes. The applicant can be anyone, but the premises must be run by a registered pharmacist or a competent person: matriculation with four years' experience in the sale of drugs, or a graduate with one year's experience in dealing with drugs.
Do I need both Form 20B and Form 21B?
Form 20B covers most drugs. Form 21B covers drugs in Schedules C and C(1). Most distributors take both together so they can stock a full range.
What is the minimum area for a wholesale drug licence?
The Drugs and Cosmetics Rules set at least 10 square metres for wholesale premises. Some states expect more for combined retail and wholesale, so check locally.
Can I start a PCD franchise before my drug licence arrives?
You can talk to the company and plan your range, but you can only buy and sell medicines once the licence is issued. Acrowell Labs holds the territory discussion until your licence is in hand.

Want to know if your district is open? See how the Acrowell franchise works or send your details below.

Is your district still open?

Tell us where you work and what you want to stock. You get the products open in your territory, the rate list and the monopoly terms, usually within one working day.

WhatsApp +91 91387 87100 Call +91 91387 87100 acrowelllabs@gmail.com Head office: 10/5 Arjun Nagar, behind Satya Nursing Home, Pipli Road, Kurukshetra, Haryana
Corporate office: Unit 505, 5th Floor, Motiaz Business Park, Zirakpur, Mohali, Punjab
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