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

Deepti Mudgal

Deepti Mudgal

Published on: Feb 20, 2026

Akshit Rai

Updated on: Feb 20, 2026

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INTRODUCTION

A license to sell, stock, exhibit or offer for sale, or distribute drugs is crucial as it requires strict oversight from drug authorities to prevent misuse of the substances and this is tracked easily under the Drugs & Cosmetics Act,1940.

APPLICABLE PROVISION

Rule 59,61(3) of Drug Rules,1945

DOCUMENTS REQUIRED

Application Form: Form 19-C (for Schedule X drugs).
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: Memorandum of Association / Articles of Association (Company), Partnership Deed (Partnership), Limited Liability Partnership Agreement (LLP)
Identity proof: Identification and address proof (Aadhaar, Passport, Driving License) for proprietor/partners/directors.
Proof of Premises: Ownership documents or rent agreement/lease deed with owner’s No Objection Certificate (NOC).
Site Plan: Blueprint/layout of the premises showing carpet area, location, and dimensions.
Storage Proof: Documents for available space, cold storage, refrigerators, etc..
Cover Letter: With applicant details and designation.

PROCESS OF LICENSE

Applicant shall fill out and submit Form 19C (If for retail then Form 20F and if for wholesale then Form 20G), along with the prescribed fee of Rs. 500/- and with the required documents to licensing authority; Upon satisfactory inspection and verification, the licensing authority issues the license.

PROCESS OF RENEWAL

Applicant shall submit the renewal application in Form 19C before the license expires by applying within six months of expiry by paying prescribed renewal fee.

VALIDITY OF LICENSE

The License is valid for 5 years from the date of grant or renewal, it remains valid unless suspended or cancelled earlier by the licensing authority.

Procedure for Licence to Sell, Stock, Exhibit or Offer for Sale, or Distribute Drugs Specified in Schedule X								
INTRODUCTION
A license to sell, stock, exhibit or offer for sale, or distribute drugs is crucial as it requires strict oversight from drug authorities to prevent misuse of the substances and this is tracked easily under the Drugs & Cosmetics Act,1940.

APPLICABLE PROVISION
Rule 59,61(3) of Drug Rules,1945
DOCUMENTS REQUIRED

Application Form: Form 19-C (for Schedule X drugs).
	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: Memorandum of Association / Articles of Association (Company), Partnership Deed (Partnership), Limited Liability Partnership Agreement (LLP)
	Identity proof: Identification and address proof (Aadhaar, Passport, Driving License) for proprietor/partners/directors.
	Proof of Premises: Ownership documents or rent agreement/lease deed with owner's No Objection Certificate (NOC).
	Site Plan: Blueprint/layout of the premises showing carpet area, location, and dimensions.
	Storage Proof: Documents for available space, cold storage, refrigerators, etc..
	Cover Letter: With applicant details and designation.

PROCESS OF LICENSE
Applicant shall fill out and submit Form 19C (If for retail then Form 20F and if for wholesale then Form 20G), along with the prescribed fee of Rs. 500/- and with the required documents to licensing authority; Upon satisfactory inspection and verification, the licensing authority issues the license.
PROCESS OF RENEWAL
Applicant shall submit the renewal application in Form 19C before the license expires by applying within six months of expiry by paying prescribed renewal fee.
VALIDITY OF LICENSE
The License is valid for 5 years from the date of grant or renewal, it remains valid unless suspended or cancelled earlier by the licensing authority.

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