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What is Form 20 & Form 21? – Retail Drug Licenses by PSR Compliance
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Wed, May 20 2026

Raju Karn

What is Form 20 & Form 21? – Retail Drug Licenses (2026)

Retail pharmacies and chemist shops are an important part of India’s healthcare system. Any business that wants to legally sell medicines directly to customers must obtain the required drug license under the Drugs and Cosmetics Act, 1940.

Among the most commonly issued retail drug licenses are Form 20 and Form 21. These licenses are issued by the State Drug Control Department and allow pharmacies to sell different categories of medicines.

This guide explains what Form 20 and Form 21 are, who needs them, their differences, eligibility requirements, and the registration process in simple terms.

What is Form 20?

Form 20 is a retail drug license issued by the State Drug Control Department under the Drugs and Cosmetics Act, 1940. This license allows pharmacies, chemist shops, and medical stores to legally sell general allopathic medicines directly to customers. It is one of the most common drug licenses required for operating a retail pharmacy in India.

The license mainly covers medicines that are not included under Schedule C and Schedule C1 of the Drugs and Cosmetics Rules. These are usually regular medicines that do not require special storage conditions like refrigeration or cold chain handling.

Form 20 is commonly used by:

  • Retail medical stores
  • Local chemist shops
  • Hospital pharmacies
  • Standalone pharmacies
  • General medicine outlets

The medicines covered under Form 20 generally include:

  • Tablets
  • Capsules
  • Syrups
  • Ointments
  • Creams
  • Pain relief medicines
  • Antibiotics (non-injectable)
  • Common prescription medicines
  • Over-the-counter medicines

A business cannot legally sell these medicines without obtaining a valid Form 20 license from the state drug authority. Selling medicines without a license may result in penalties, cancellation of business operations, or legal action.

To obtain Form 20, the pharmacy must meet certain conditions such as:

  • Having a suitable commercial premises
  • Appointing a registered pharmacist or qualified competent person
  • Maintaining proper storage facilities
  • Following drug safety and record-keeping requirements

Form 20 is important because it helps ensure that medicines sold to the public are:

  • Genuine and approved
  • Properly stored
  • Safely handled
  • Dispensed under professional supervision

In simple terms, if you want to open a regular medical store or pharmacy in India and sell general allopathic medicines, obtaining a Form 20 retail drug license is mandatory.

Who Needs Form 20?

Form 20 is required for businesses involved in:

  • Retail sale of general allopathic medicines
  • Running a pharmacy or chemist shop
  • Selling medicines directly to consumers

Examples of Businesses That Need Form 20

  • Medical stores in residential or commercial areas
  • Standalone chemist shops
  • Hospital pharmacies selling medicines to walk-in patients
  • Retail pharmacies selling tablets, syrups, ointments, and capsules

What is Form 21?

Form 21 is also a retail drug license, but it is specifically issued for the sale of Schedule C and Schedule C1 drugs.

These medicines require stricter handling, storage, and monitoring because they are considered sensitive pharmaceutical products.

Schedule C and C1 Drugs Include

  • Vaccines
  • Biological products
  • Insulin
  • Injectable antibiotics
  • Sera and similar medicines

Who Needs Form 21?

A Form 21 license is needed if your pharmacy plans to:

  • Sell vaccines or injectable medicines
  • Store and distribute biological products
  • Operate a pharmacy handling Schedule C and C1 drugs

Key Features of Form 20 and Form 21 Licenses

AspectForm 20Form 21
Applicable DrugsGeneral allopathic medicinesSchedule C & C1 drugs
Issuing AuthorityState Drug Control DepartmentState Drug Control Department
Suitable ForGeneral pharmacies and chemistsPharmacies selling vaccines and injectables
Storage RequirementsStandard storage facilitiesRefrigeration and cold chain may be required
Qualified PersonnelRegistered pharmacist or competent personRegistered pharmacist or competent person
ValidityTypically 5 years, renewableTypically 5 years, renewable

Eligibility Criteria for Form 20 and Form 21

To apply for either license, the business must meet certain conditions.

Premises Requirement

The pharmacy premises must meet the minimum area requirement prescribed by the state authority. In many states, a retail pharmacy requires at least 10 square meters of space.

Qualified Personnel

The pharmacy must appoint:

  • A registered pharmacist, or
  • A competent person with required qualification and experience

Storage Facilities

The premises must have proper storage arrangements to safely store medicines. For Form 21, refrigeration and cold chain systems may also be necessary.

Registration Process for Form 20 and Form 21 License

Step 1: Finalize the Pharmacy Premises

Choose a commercial premises suitable for operating a pharmacy. Ensure the premises meet the minimum area and storage requirements.

Step 2: Appoint a Registered Pharmacist

Hire a qualified registered pharmacist who will supervise the sale and handling of medicines.

Step 3: Prepare Required Documents

Collect all required documents such as:

  • Identity and address proof
  • Pharmacist registration certificate
  • Premises proof
  • Rent agreement or ownership proof
  • Refrigerator details (for Form 21 if applicable)

Step 4: Submit Application to State Drug Authority

File the application with the State Drug Control Department through the prescribed online or offline process.

Step 5: Inspection by Drug Inspector

The Drug Inspector may inspect the pharmacy premises to verify:

  • Storage facilities
  • Refrigerator and cold chain setup
  • Availability of pharmacist
  • Compliance with drug storage norms

Step 6: Verification and Approval

After successful verification, the licensing authority reviews the application and grants the license.

Step 7: Issuance of Form 20 and/or Form 21 License

Once approved, the pharmacy receives the retail drug license and can legally begin selling medicines.

Difference Between Form 20 and Form 21

Form 20

Allows retail sale of general allopathic medicines.

Form 21

Allows retail sale of Schedule C and C1 medicines that require stricter storage and handling.

Why Are These Licenses Important?

Legal Compliance

Selling medicines without a valid drug license is illegal in India.

Public Safety

These licenses ensure medicines are genuine, properly stored, and safely distributed.

Consumer Trust

Licensed pharmacies build confidence among customers and healthcare professionals.

Conclusion

If you plan to open a pharmacy or chemist shop in India, obtaining the correct drug licenses is essential. Form 20 and Form 21 allow pharmacies to legally sell different categories of medicines while ensuring compliance with the Drugs and Cosmetics Act.

Understanding the difference between these licenses helps avoid regulatory issues and supports smooth pharmacy operations.

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Frequently Asked Questions (FAQs)

Is Form 20 mandatory for opening a medical store?

Yes. A Form 20 license is required for selling general allopathic medicines through a retail pharmacy.

Can a pharmacy operate with only Form 20?

Yes, but only for general medicines. To sell vaccines or injectable drugs, Form 21 is also required.

Who issues Form 20 and Form 21 licenses?

These licenses are issued by the State Drug Control Department.

What is the validity of Form 20 and Form 21?

The licenses are generally valid for 5 years and can be renewed.

Is a registered pharmacist mandatory?

Yes. A registered pharmacist or qualified competent person is required.

Can Form 20 and Form 21 be obtained together?

Yes. Most pharmacies apply for both licenses together to sell a wider range of medicines.

Are refrigeration facilities compulsory for Form 21?

Yes. Proper cold storage may be required for vaccines and biological products.

What happens if medicines are sold without a drug license?

Selling medicines without a valid license can result in penalties, cancellation, or legal action.

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