Drug Sale License Procedure in India (Non-Schedule X)

Deepti Mudgal

Deepti Mudgal

Published on: Mar 27, 2026

Shatakshi Sharma

Updated on: Mar 27, 2026

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INTRODUCTION

A license to sell, stock, exhibit or offer for sale, or distribute drugs Other Than Those Specified in Schedule X is essential as it requires strict oversight from drug authorities to prevent misuse of the substances and this allows government oversight from manufacture to sale, under the Drugs and Cosmetics Act, 1940 and Drugs and Cosmetics Rules, 1945.

APPLICABLE PROVISION

Rule: 59,61(2),62B,64 of Drug Rules,1945

DOCUMENTS REQUIRED

Application Form: Form 19
Fee Challan: Proof of fee payment.
Declarations: Affidavits in prescribed formats, including one for the proprietor/director/partner and a special one for the registered pharmacist/competent person, stating that there are no prior convictions.
Business Constitution: MOA/AOA (Company), Partnership Deed (Partnership), LLP Agreement (LLP).
Identity proof: ID & address proof (Aadhar, Passport, DL) for proprietor/partners/directors.
Proof of Premises: Ownership documents or rent agreement/lease deed with owner’s NOC.
Site Plan: Blueprint/layout of the premises showing carpet area, location, and dimensions.
Storage Proof: Documents for available space, including storage conditions such as refrigeration where required
Cover Letter: With applicant details and designation.

PROCEDURE

Applicant shall fill out and submit Form 19; the licence for retail sale is issued in Form 20 or Form 21 (as applicable), and for wholesale in Form 20B or Form 21B, as the case may be, along with the prescribed fee of one thousand five hundred rupees (Rs.1500/-) with the required documents; upon satisfactory inspection and verifying that the premises are on an area of not less than 10 square metres (for retail) or fifteen (15) square metres (for wholesale, where applicable), the Licensing Authority issues the licence.

VALIDITY

The licence is perpetual, subject to payment of retention fee as prescribed, and it remains valid unless suspended or cancelled earlier by the Licensing Authority.

RENEWAL

Applicant can pay retention fee every five (5) years to keep the licence in force.

Procedure for Licence to Sell, Stock, Exhibit or Offer for Sale, or Distribute Drugs Other Than Those Specified in Schedule X								
INTRODUCTION
A license to sell, stock, exhibit or offer for sale, or distribute drugs Other Than Those Specified in Schedule X is essential as it requires strict oversight from drug authorities to prevent misuse of the substances and this allows government oversight from manufacture to sale, under the Drugs and Cosmetics Act, 1940 and Drugs and Cosmetics Rules, 1945.
APPLICABLE PROVISION
Rule: 59,61(2),62B,64 of Drug Rules,1945
DOCUMENTS REQUIRED

Application Form: Form 19
	Fee Challan: Proof of fee payment.
	Declarations: Affidavits in prescribed formats, including one for the proprietor/director/partner and a special one for the registered pharmacist/competent person, stating that there are no prior convictions.
	Business Constitution: MOA/AOA (Company), Partnership Deed (Partnership), LLP Agreement (LLP).
	Identity proof: ID & address proof (Aadhar, Passport, DL) for proprietor/partners/directors.
	Proof of Premises: Ownership documents or rent agreement/lease deed with owner's NOC.
	Site Plan: Blueprint/layout of the premises showing carpet area, location, and dimensions.
	Storage Proof: Documents for available space, including storage conditions such as refrigeration where required
	Cover Letter: With applicant details and designation.

PROCEDURE
Applicant shall fill out and submit Form 19; the licence for retail sale is issued in Form 20 or Form 21 (as applicable), and for wholesale in Form 20B or Form 21B, as the case may be, along with the prescribed fee of one thousand five hundred rupees (Rs.1500/-) with the required documents; upon satisfactory inspection and verifying that the premises are on an area of not less than 10 square metres (for retail) or fifteen (15) square metres (for wholesale, where applicable), the Licensing Authority issues the licence.
VALIDITY
The licence is perpetual, subject to payment of retention fee as prescribed, and it remains valid unless suspended or cancelled earlier by the Licensing Authority.
RENEWAL
Applicant can pay retention fee every five (5) years to keep the licence in force.

Industry Specific

Procedure for Licence to Sell, Stock, Exhibit or Offer for Sale, or Distribute Drugs Other Than Those Specified in Schedule X