New Delhi Drug Licenses: Which One Applies to Your Pharmacy?

Why Do You Need a Drug License in New Delhi?

The Delhi State Drug Control Department ensures that pharmaceutical trade is regulated, safe, and in public interest. A drug license is mandatory for:

• Retail sale of medicines (pharmacies/medical shops)

• Wholesale drug distribution

• Online medicine delivery (e-pharmacy)

• Drug manufacturing and repacking

• Ayurvedic, Siddha, or Unani product sales

Types of Drug Licenses in New Delhi

Depending on your pharmacy’s business model, you may require one or more of the following licenses:

1. Retail Drug License (Form 20 & 21)

Purpose: To sell medicines directly to end consumers through a pharmacy or medical shop.

• Form 20 – General drugs (non-prescription)

• Form 21 – Scheduled drugs (e.g., Schedule H, H1, X)

Who Needs It:

• Standalone pharmacies

• Hospital pharmacies (open to the public)

• Chemist shops

Requirements:

• Minimum area: 10 sq. meters

• Pharmacist with valid D.Pharm/B.Pharm registration (DPCI)

• Refrigerator and storage conditions as per norms

2. Wholesale Drug License (Form 20B & 21B)

Purpose: For distribution or wholesale of medicines to retailers, hospitals, and institutions.

• Form 20B – Non-scheduled wholesale drugs

• Form 21B – Scheduled prescription drugs

Who Needs It:

• Drug wholesalers/distributors

• Super stockists

• Online pharmacies with warehousing

Requirements:

• Minimum area: 15 sq. meters

• Qualified person (pharmacist or experienced graduate)

• Documented cold chain (if dealing with temperature-sensitive drugs)

3. Restricted License (Form 20A & 21A)

Purpose: For non-pharmacist sellers (e.g., general stores) selling limited OTC drugs.

• Applicable only to specific non-prescription drugs

• Not allowed to sell Schedule H/X drugs

4. Manufacturing License (Form 25, 28, etc.)

Purpose: Required to manufacture allopathic drugs, repack medicines, or produce ayurvedic formulations.

• Form 25 – Allopathic drug manufacturing

• Form 28 – Schedule C/C1 drugs (injections, vaccines)

• Form 25D – Cosmetics manufacturing

• Form 24B – Repacking license

Who Needs It:

• Drug manufacturing units

• Contract manufacturers

• Cosmetic manufacturers in Delhi

5. Ayurvedic & Unani Drug License

Issued by the Department of Ayush, Delhi, for selling or manufacturing herbal/AYUSH products.

Requirements:

• Qualified Ayurveda/Unani expert (BAMS/BUMS)

• Herbal formulation space

• GMP compliance for manufacturing

6. E-Pharmacy License

With digital medicine delivery on the rise, New Delhi also allows e-pharmacies to operate under proper licensing.

• Must hold both retail and wholesale license

• Comply with IT Act and Drugs Rules

• Dedicated storage and pharmacist oversight required

How to Choose the Right License for Your Pharmacy in Delhi Business TypeRequired License(s)Retail PharmacyForm 20 & Form 21Wholesale DistributionForm 20B & Form 21BHospital Pharmacy (Public Sale)Form 20/21Online Pharmacy (with stock)Form 20/21 + 20B/21BManufacturing UnitForm 25, 28, etc.Ayurvedic Drug ShopAYUSH License (Dept. of Ayush)Cosmetic Shop/ManufacturerForm 32 & 32A

Application Process for Drug License in Delhi Step-by-Step Process:

1. Visit the official portal: https://xlnindia.gov.in/

2. Register your firm and applicant details

3. Fill out the online application for the relevant form

4. Upload required documents

5. Pay the fee online

6. Schedule for inspection by Drug Inspector

7. Receive drug license after verification

Documents Required

• PAN, GST, and business registration

• Pharmacist qualification and registration proof

• Site layout & premises ownership/rental documents

• Refrigerator purchase bill and electricity connection

• Photograph, signature, and ID proof

• Affidavit and declaration forms

Final Thoughts

Choosing the right drug license for your Delhi-based pharmacy is essential for legal and hassle-free operations. Whether you're a retailer, wholesaler, or manufacturer, compliance with the Delhi State Drug Control norms ensures smooth approval and renewals.

Read more here: https://www.psrcompliance.com/blog/what-are-the-key-documents-needed-for-a-drug-license

Psr Compliance is a leading consultancy firm specializing in regulatory compliance, certifications, and licensing for businesses across India.