Drug License Online Registration India 2025 – Step by Step Guide by CA Sandeep Rawat
Drug License Registration in India – Retail, Wholesale & Manufacturing
Author: CA Sandeep Rawat | Email: sandeeprawatca@gmail.com | Contact: 9315776867
Drug and Cosmetics Act, 1940
Drug license is mandatory under the Drugs & Cosmetics Act, 1940 which regulates the import, manufacture, distribution, and sale of drugs and cosmetics, including allopathic, homeopathic, Ayurvedic, Siddha, and Unani medicines.
Importance of Drug License
- Gives legal permission to sell, resell, manufacture, trade, or market drugs and cosmetics.
- Ensures the quality and safe usage of drugs in India.
- Protects the public from misuse or abuse of medicines.
- Dealing with drugs without a license is a cognizable offence.
- Specifies rules and regulations for the premises and business operations.
Who Needs a Drug License?
Any business dealing with drugs or cosmetics, including individuals, partnerships, LLPs, companies, or corporations distributing drugs in India must hold a valid drug license:
- Businesses dealing with cosmetics for human use or beautification.
- Businesses selling medicines for internal or external use in humans or animals.
- Manufacturers and distributors of insect-repelling drugs and medicines.
- Dealers of empty gelatin capsules.
- Businesses manufacturing, storing, or distributing medicines for diagnosis, treatment, prevention, or mitigation of diseases.
Basic Requirements for Drug License
- Area Requirement: Minimum 10 sq. meters for a medical shop; 15 sq. meters for combined retail & wholesale.
- Storage Facility: Refrigeration and air conditioning for drugs like vaccines and insulin.
- Technical Staff: Retail requires a registered pharmacist present during working hours. Wholesale requires a qualified pharmacist or a competent person approved by the state drug control department.
Types of Drug License
Sale License
Two main types of sale licenses:
- Retail License: For selling drugs in India.
- Wholesale License: For businesses engaged in wholesale distribution of drugs.
Application Processing Time
Timeframe for grant or renewal of retail, wholesale, and manufacturing licenses: 14 days from the date of application.
Documents Required
Documents for retail license include:
- Statutory application form – Form 19 (for Form 20/21 licenses).
- Residential proof of proprietor/partner/director/pharmacist.
- Partnership deed or list of directors signed by company secretary/MD.
- Affidavit on Rs. 20 stamp paper for company directors.
- Special declaration by registered pharmacist on Rs. 20 stamp paper.
- Self-attested copy of registered pharmacist certificate with photo & signature.
- Premises plan indicating carpet area with signatures.
- Proof of ownership of the premises (Encumbrance Certificate or legal document).
For wholesale license, additional experience certificate of the competent person and Form 19 for licenses in Form 20B/21B are required.
Verification by Drug Inspector
- Site inspection to verify area, storage facilities, and compliance with statutory limits.
- Inspection report submitted to Assistant Director for verification of documents.
Obtaining Drug License
The approved license can be downloaded from the Drugs Control Administration website. The license must be prominently displayed and all conditions must be complied with throughout business operations.
Professional Assistance
For queries or assistance, connect with:
CASandeep Rawat.
Email: sandeeprawatca@gmail.com
Contact: 9315776867
Managed by CA Sandeep Rawat – Expert in compliance, taxation, and business advisory.
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