Drug License in Bihar – Step by Step Application Guide (2026)

If you want to manufacture, sell, stock, distribute, or wholesale medicines in Bihar, obtaining a drug license is mandatory under the Drugs and Cosmetics Act, 1940. Without a valid license, operating a pharmacy, wholesale unit, or manufacturing setup is illegal and can attract heavy penalties.

This guide explains everything you need to know about drug license in Bihar, including application process, Form 20 and 21 drug license, wholesale drug license, renewal, verification, and drug license download—written in simple, practical language.

What is a Drug License?

A drug license is an official approval issued by the Drug Control Department that allows individuals or companies to deal in drugs and medicines legally. It ensures that medicines sold or distributed meet safety, quality, and storage standards.

In Bihar, drug licenses are issued by the State Drug Control Authority under the supervision of the Central Drugs Standard Control Organization (CDSCO).

Types of Drug Licenses in Bihar

Depending on your business model, different drug licenses apply:

1. Retail Drug License (Form 20 & 21)

● Form 20: For retail sale of drugs other than Schedule C and C(1)

● Form 21: For retail sale of Schedule C and C(1) drugs (excluding Schedule X)

These licenses are required for medical stores and pharmacies selling medicines directly to consumers.

2. Wholesale Drug License

A wholesale drug license is required if you supply medicines to retailers, hospitals, or other wholesalers. Storage conditions and appointment of a competent person are mandatory.

3. Manufacturing Drug License

Required for companies involved in manufacturing medicines, cosmetics, or medical drugs. This license involves stricter inspections and compliance requirements.

Who Needs a Drug License in Bihar?

You need a drug license if you are:

▸Opening a medical store or pharmacy

▸Running a wholesale medicine business

▸Manufacturing drugs or pharmaceuticals

▸Supplying medicines to hospitals or clinics

▸Operating an online pharmacy (with conditions)

Advantages of Drug License in Bihar

Obtaining a drug license in Bihar offers several important benefits for individuals and businesses involved in the pharmaceutical sector:

• Legal Authorization to Operate: A valid drug license allows you to legally manufacture, sell, stock, distribute, or wholesale drugs in Bihar as per the Drugs and Cosmetics Act, 1940.

• Builds Trust with Customers & Authorities: Licensed pharmacies and wholesalers gain higher credibility among customers, hospitals, distributors, and regulatory authorities.

• Smooth Drug License Verification: A registered license makes drug license verification easier for inspections, audits, and online checks by CDSCO or state drug authorities.

• Business Expansion Opportunities: With a valid wholesale or retail drug license, businesses can expand operations, supply to hospitals, clinics, and participate in government or private tenders.

• Easy Renewal & Compliance: Holding a valid license simplifies drug license renewal and ensures continuous compliance with regulatory requirements.

• Avoids Penalties & Legal Issues: Operating without a license can lead to heavy penalties, seizure of drugs, or cancellation of business activities. A valid license protects your business from such risks.

• Supports Online Processes: Licensed entities can easily access drug license download, renewal, and application status through the online portal.

Drug License Application Process in Bihar

The drug license application process in Bihar is mostly online, followed by physical inspection.

Step 1: Prepare Documents

Ensure all documents are complete before applying to avoid delays.

Step 2: Online Application Submission

• Apply through the State Drug Control portal or designated online system
• Select the correct license type (Retail, Wholesale, or Manufacturing)
• Upload documents and pay the prescribed fee

Step 3: Inspection by Drug Inspector

The Drug Inspector conducts a site inspection to verify:

• Storage conditions
• Refrigerator and temperature control
• Presence of a registered pharmacist or competent person
• Compliance with legal requirements

Step 4: Grant of Drug License

If the inspection and documents are satisfactory, the drug license is issued.

Documents Required for Drug License in Bihar

Common documents include:

→ Application form (as per license type)

→ Identity and address proof of applicant

→ Shop ownership proof or rent agreement

→ Layout plan of premises

→ Refrigerator purchase bill

→ Affidavit and declaration

→ Qualification certificates of pharmacist or competent person

→ Appointment letter of pharmacist

Drug License Renewal in Bihar

A drug license renewal must be done before expiry to continue operations legally.

Renewal applications are filed online

Late renewal may attract penalties

Inspection may be required again in some cases

Timely renewal helps avoid suspension or cancellation of the license.

Drug License Verification

Drug license verification allows you to check whether a license is valid and genuine.

You can verify by:

⁃ Checking the official drug control portal

⁃ Matching license number and firm details

⁃ Confirming validity and scope of license

⁃ Verification is important for distributors, hospitals, and business partners.

Drug License Download Process

Once approved, you can complete the drug license download from the official portal:

▪ Log in using your credentials

▪ Navigate to approved licenses

▪ Download and print the license certificate

▪ A copy of the license must be displayed at the business premises.

Common Reasons for Drug License Rejection

⚠ Incomplete or incorrect documents

⚠ Inadequate storage conditions

⚠ Absence of qualified pharmacist

⚠ Premises not meeting size requirements

⚠ Incorrect license category selection

Penalties for Operating Without a Drug License

Running a drug business without a valid license can result in:

➤ Heavy fines

➤ Seizure of medicines

➤ Business closure

➤ Legal action under Drugs and Cosmetics Act

Need Assistance with Drug License in Bihar?

From application to approval, PSR Compliance helps you meet drug license requirements in Bihar.
📞 +91-7065883416

Frequently Asked Questions (FAQs)

1. Is a qualified pharmacist mandatory for running a pharmacy?

Yes. A registered pharmacist is mandatory for operating a retail pharmacy, and their physical presence is required during business hours.

2. What is the minimum area required to open a pharmacy?

A minimum area of 10 square meters is generally required for both retail and wholesale pharmacy shops, subject to local regulations.

3. How long does it take to get a pharmacy license?

The pharmacy license approval process usually takes 30 to 60 days, depending on document verification and inspection timelines.

4. What documents are required to apply for a pharmacy license?

Key documents typically include:

• Site plan of the premises
• Proof of ownership or rental agreement
• Affidavit for the registered pharmacist
• Constitution of the firm (Partnership Deed, LLP agreement, or incorporation certificate)

5. What is the difference between Form 20 and Form 21?

Form 20 is issued for the sale of general drugs.

Form 21 is required for selling Schedule C and C1 drugs, including biological products.

6. How often does a pharmacy license need renewal?

Pharmacy licenses must be renewed every 5 years. The renewal application should be submitted at least 30 days before the expiry date.

7. What is the penalty for operating a pharmacy without a license?

Operating without a valid license can result in strict legal action, including heavy fines and possible imprisonment, as per drug control regulations.