If you are planning to start a business in the pharmaceutical sector—whether it’s a retail pharmacy, a wholesale distribution unit, or a manufacturing facility—you must obtain a drug license. In Delhi, this license is mandatory under the Drugs and Cosmetics Act, 1940, and is regulated by the Drugs Control Department, Government of NCT of Delhi.

A drug license ensures that your business complies with laws governing the sale, storage, and distribution of drugs and medical products. Without this license, operating any drug-related business is illegal and subject to penalties, including fines and closure of operations.

Types of Drug Licenses in Delhi

There are several types of drug licenses, depending on the nature of your business:

1. Retail Drug License (RDL)
   For individuals or businesses selling drugs directly to customers, such as medical shops, pharmacies, or chemists.

2. Wholesale Drug License (WDL)
   For distributors or stockists who sell drugs to retailers, hospitals, or other wholesalers, but not directly to the public.

3. Manufacturing Drug License
   Required for units engaged in the manufacturing or repackaging of drugs or cosmetics.

4. Restricted License for General Stores
   For general stores intending to sell over-the-counter (OTC) drugs that don’t require a pharmacist.

Each of these licenses comes with specific compliance requirements related to infrastructure, staff qualification, and documentation.

Key Requirements for Obtaining a Drug License in Delhi

To apply for a drug license in Delhi, the applicant must fulfill the following key conditions:

1. Qualified Person: A competent individual with a degree in pharmacy (B.Pharm) or diploma in pharmacy (D.Pharm) registered with the Delhi Pharmacy Council. For wholesale licenses, a graduate with relevant experience may also qualify.

2. Business Premises: The premises must have adequate space (usually a minimum of 10–15 square meters), proper ventilation, clean storage conditions, and refrigeration for temperature-sensitive medicines.

3. Ownership Documents: This includes proof of ownership or rental agreement, property tax receipt, and site plan.

4. Registration on Online Portal: Applications must be submitted through the online Drugs Licensing Portal of Delhi Government, along with the prescribed fees.

5. Other Documents: PAN card, photo ID, company constitution (in case of partnership/private limited firm), and affidavit/declaration forms are also required.

Application Process

1. Online Registration: Create an account on the Delhi Drugs Control portal.

2. Form Submission: Fill in the required details and upload supporting documents.

3. Fee Payment: Pay the license fee online.

4. Inspection: A Drug Inspector will inspect the premises and verify the documents.

5. Approval & Issuance: Once verified, the license is granted digitally.

The entire process can take 30–45 working days, depending on the accuracy and completeness of your submission.

Validity and Renewal

Drug licenses issued in Delhi are generally valid for five years. Renewal applications must be submitted at least 30 days before expiry to avoid penalties or cancellation. In case of changes in business address, constitution, or pharmacist in charge, the license must be updated accordingly.

Why It Matters

Operating without a drug license is not just a legal risk—it can severely damage your business reputation. A valid license:

1. Builds trust with suppliers, customers, and regulators

2. Enables access to wholesale and branded products

3. Opens doors to government tenders and institutional supplies

4. Protects your business from fines, legal action, or closure

Need Help?

At PSR Compliance, we assist businesses in navigating the end-to-end process of obtaining and maintaining drug licenses in Delhi and across India. Our experts help with documentation, follow-ups, and inspections to ensure smooth approvals without delays.

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