What is Form 20b and 21b Drug License?

What is Form 20b and 21b Drug License?

In case you are intending to venture into the pharmaceutical industry in India, particularly as a wholesaler or a distributer, then acquiring a drug license is one of the initial legalities to observe. To be precise, you should know about Form 20B and Form 21B of Drugs and Cosmetics Act, 1940. These are mandatory wholesale licenses issued by the Drug Control Department. They allow you to sell, stock, exhibit, or distribute drugs either generally (Form 20B) or specially for Schedule C and C1 drugs (Form 21B). These licenses are your legal gate pass to enter and grow in the pharmaceutical distribution market.

Understanding the Legal Foundation of Drug Licenses

The Drugs and Cosmetics Act, 1940, and Rules of 1945 regulate drug manufacturing, sale, and distribution in India. The aim is simple—only safe and quality-tested drugs should reach patients.
Under this law:

• You need Form 20B for wholesale trading of non-biological allopathic drugs.
• You need Form 21B for Schedule C and C1 drugs like insulin, vaccines, and antibiotics.

These licenses are issued by the State Drug Licensing Authority (SDLA) where your business is based.

Who Needs These Licenses?

The licenses are meant for:

• Pharmaceutical wholesalers
• Pharma distributors
• Stockists
• Corporate hospitals with in-house pharmacies
• Third-party logistics providers handling drugs

If you're selling or storing drugs in bulk, you must have these two forms. Without them, your operation is illegal and liable for heavy penalties.

Read More  How to get a Drug License in Delhi

What Is Form 20B License?

Form 20B is issued to wholesalers who distribute general allopathic medicines that do not fall under Schedule C or C1.

Covered products include:

• Over-the-counter (OTC) drugs
• Non-biological prescription drugs
• Tablets, capsules, ointments (excluding vaccines and serums)

Why it matters:

Form 20B ensures that non-specialist drugs are sold only by trained vendors who understand drug safety norms and follow storage conditions.

What Is Form 21B License?

This has to be in form 21B in case you are handling schedule C and C1 drugs which are highly sensitive. These include:

• Vaccines
• Serums
• Injectable antibiotics
• Blood products
• Insulin
• Hormones

Why it matters:

These drugs need special handling—cold storage, expert care, and rapid distribution. Form 21B ensures that only qualified distributors manage such critical drugs.

Key Differences Between Form 20B and 21B

Documents Needed for Form 20B and 21B Registration

Getting these licenses requires a complete set of verified documents. Missing even one may lead to rejection.

1. Application Form in Prescribed Format
2. Covering Letter (signed by authorized person)
3. Proof of Premises (Rental agreement or ownership deed)
4. Site Plan/Layout of the storage facility
5. Declaration Form (as per Rule 65)
6. Pharmacist's Qualification Certificate (B.Pharm or D.Pharm)
7. Pharmacist's Registration Certificate
8. Experience Letter (if required)
9. ID and Address Proof of Proprietor/Partners/Directors
10. Affidavit for Technical Staff
11. Electricity and Tax Bill (for address verification)
12. Cold Storage Proof (for 21B, if applicable)

Read More How to Apply for a Drug License Wholesale and Retail Online

Step-by-Step Process to Apply for 20B/21B License

The application procedure has moved online in most states making the process smoother

Step 1: Choose the Right Drug License Portal

Visit your state's Drugs Control Department website.

Step 2: Create Your Profile

Register your business and upload key details—business name, location, contact info.

Step 3: Fill Application Form

Choose the type of license (Form 20B or Form 21B or both). Enter applicant info, drug type, premises details, and staff details.

Step 4: Upload Required Documents

Submit clear and valid scanned copies of all documents listed above

Step 5: Pay the License Fee

The fees vary slightly across states but are usually in the range of INR 3,000 to INR 6,000

Step 6: Site Inspection by Drug Inspector

An official will inspect your facility. They will verify:

• Storage hygiene
• Drug safety
• Record keeping
• Availability of cold storage (for 21B)

Step 7: Get the License

If everything is in order the authority issues your Drug License in Form 20B/21B usually within 15–30 working days

Validity and Renewal of Form 20B and 21B

• These licenses are valid for 5 years.
• Renewal application should be filed before expiry.
• Delay in renewal can result in penalty or cancellation.

You should also maintain stock registers, sales records and expiry records to stay compliant

Final Thoughts

The network of distribution of drugs in India is huge. However, along with it, there is a risk of falsified or handled drugs. The Forms 20B and 21B Drug Licensing system helps discard unethical business and inserts only competent business to deal with sensitive categories of drugs.

These licenses are the backbone of your business whether you are starting out a new project or going large with your pharmaceuticals distribution.

Navigating the drug license registration process can be time-consuming and complex. That’s where Agile Regulatory comes in. Our experts handle everything—from documentation to inspections—so you stay focused on your business.

Let Agile Regulatory simplify your Form 20B/21B licensing journey.