Aug 31 2025
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Drug Licence Form 20 & 21 in India: Complete Guide (2024–2025)

Running a business in the pharmaceutical sector in India requires strict compliance with the Drugs and Cosmetics Act, 1940 and related rules. Whether you are planning to open a retail pharmacy, wholesale drug store, or distribution business, obtaining a valid drug licence is mandatory.

Among the most commonly issued licences in India are Drug Licence Form 20 and Form 21. These forms authorize businesses to sell, stock, distribute, or exhibit drugs and medicines under specific categories.

This article explains what Drug Licence Form 20 and 21 mean, their eligibility, documents required, application process, validity, and compliance in India (2024–2025).

1. What is a Drug Licence in India?

A Drug Licence is an official permit issued by the State Drugs Standard Control Organization (SDSCO) or the Central Drugs Standard Control Organization (CDSCO). It allows businesses to legally deal in pharmaceuticals.

  • No person or business can sell, stock, or distribute medicines in India without a valid drug licence.
  • Each state issues its own licences, though the rules are based on the national Drugs & Cosmetics Act, 1940.
  • Different forms are prescribed for different types of businesses.

2. Understanding Form 20 & Form 21

The government issues licences in specific Forms depending on the type of drug and business model.

Form 20 – Retail/Wholesale Licence for Non-Schedule X Drugs

  • Form 20 is required for retail or wholesale sale of drugs (excluding those covered under Schedule X).
  • Examples: General medicines, antibiotics, syrups, ointments, tablets, injections, etc.
  • Issued to pharmacies, druggists, chemists, and distributors.

Form 21 – Retail/Wholesale Licence for Schedule C & C1 Drugs

  • Form 21 is mandatory for businesses dealing with biological and special category drugs such as:
    • Vaccines
    • Insulin
    • Sera
    • Toxins
    • Ophthalmic preparations
    • Parenteral preparations
  • These medicines are more sensitive and need stricter handling and storage conditions.

👉 In short:

  • Form 20 → General drugs (non-Schedule X).
  • Form 21 → Schedule C & C1 biological drugs.

3. Who Needs Drug Licence Form 20 & 21?

The following businesses must apply for Form 20 and/or Form 21:

  • Retail pharmacies & chemist shops.
  • Wholesale distributors of medicines.
  • Hospital pharmacies.
  • Online pharmacies (with physical storage).
  • Medical shops selling vaccines, injections, and biological products.

4. Eligibility for Drug Licence

To apply for a Drug Licence (Form 20/21) in India, the following conditions apply:

  • Premises: Minimum area of 10 sq. meters (for retail/wholesale).
  • Storage Facility: Refrigerator & cold storage for medicines.
  • Pharmacist Requirement (Retail):
    • A registered pharmacist under the Pharmacy Act, 1948, OR
    • A competent person with drug sale experience.
  • Competent Person (Wholesale):
    • A graduate with at least 1 year of experience in drug sales, OR
    • A person with 4 years of experience in pharmaceuticals.

5. Documents Required for Form 20 & 21

The following documents are generally required across most states in India:

Business Documents

  • Certificate of Incorporation / Partnership Deed / Proprietorship Proof.
  • GST Registration Certificate.
  • PAN card of business entity.
  • Address proof of premises (rent agreement/ownership papers + electricity bill).

Pharmacist / Competent Person Documents

  • Qualification Certificate (Degree/Diploma in Pharmacy).
  • Registration Certificate with Pharmacy Council.
  • Appointment/Employment letter.
  • ID proof & passport-size photographs.

Premises & Infrastructure Documents

  • Blueprint/layout of premises (10 sq. meters min.).
  • Refrigerator bills/invoices.
  • Cold storage facility proof (for vaccines & biologicals).

Other Documents

  • Affidavit regarding compliance with Drugs & Cosmetics Act.
  • Covering letter to the licensing authority.
  • Partnership deed/board resolution (for companies/LLPs).

6. Application Process for Drug Licence (Form 20/21)

The process varies slightly state-wise, but generally follows these steps:

  1. Online Application
    • Visit the State Drugs Control Department portal.
    • Select New Drug Licence Application.
    • Fill details of business, pharmacist/competent person, premises.
  2. Document Upload & Fee Payment
    • Upload scanned copies of all required documents.
    • Pay government fees online (₹3,000–₹6,000 approx. depending on type).
  3. Inspection by Drug Inspector
    • A drug inspector visits premises to check area, storage, pharmacist availability, etc.
  4. Approval & Licence Issuance
    • If all requirements are satisfied, licence is issued in Form 20 and/or Form 21.

7. Validity and Renewal

  • Validity: 5 years (unless cancelled/suspended).
  • Renewal: Must be applied before expiry.
  • Late fee may be charged for delayed renewal.

8. Key Compliance After Getting Licence

  • Maintain proper records of purchase & sale of drugs.
  • Display drug licence prominently in the shop/office.
  • Ensure pharmacist/competent person is always present.
  • Do not sell medicines after expiry date.
  • Comply with labeling and packaging norms.
  • Permit periodic inspections by authorities.

9. Penalties for Non-Compliance

Operating without a valid drug licence or violating conditions can result in:

  • Cancellation or suspension of licence.
  • Heavy fines.
  • Imprisonment (in case of serious violations).

10. Cost of Drug Licence in India

  • Retail licence (Form 20): ₹3,000 – ₹5,000 (government fee only).
  • Form 21 (Schedule C/C1 drugs): Additional ₹3,000 – ₹5,000.
  • Consultant/Professional charges: Vary between ₹10,000 – ₹25,000 depending on city & complexity.

Conclusion

Obtaining a Drug Licence Form 20 and 21 in India is a legal requirement for any business dealing in medicines, whether retail, wholesale, or hospital pharmacy.

  • Form 20 covers general drugs (non-Schedule X).
  • Form 21 covers biological & special drugs (Schedule C & C1).

With the right eligibility, documentation, and compliance, businesses can smoothly obtain and maintain their licences. Staying compliant not only avoids penalties but also builds credibility, customer trust, and long-term growth in the pharmaceutical sector.

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