Drug License – Application, Documents, Registration & Forms

Updated on: Jun 17th, 2024 | 7 min read

Ensuring everyone has equal and fair access to drugs and medicine is the primary concern of any government. But the right to manufacture and sell drugs and medicines has to be given cautiously. Hence, the government has stringent rules for granting licenses for the manufacturing and selling of drugs and medicine.

The Act that governs the end-to-end process from manufacture to the sale of drugs in India is the Drugs and Cosmetics Act, 1940 (“Act”).

Meaning of Drugs

Section 3(b) of the Drugs and Cosmetics Act, 1940 defines “drug” to include all medicines and devices for the use of human beings or animals, internally or externally, and all substances planned to be used for or in the diagnosis, mitigation, treatment, or prevention of any disorder or disease in animals or human beings.

This includes preparations applied on the human body for the purpose of repelling insects like mosquitoes; and also all substances used for the destruction of insects and all components of a drug – like empty gelatin capsules.

Note: The definition was amended in 1964 to include Ayurvedic and Unani drugs.

Purpose of Drug License

The access to medicines and drugs must be restricted and regulated to ensure that such goods are not abused or misused by individuals. Thus, all pharmacists, wholesalers, retailers, manufacturers, sellers, dealers and importers of drugs, cosmetics, Ayurvedic, Siddha and Unani drugs must mandatorily obtain a drug license under the Drugs and Cosmetics Act, 1940.

The main purpose of the drug license is to grant legal permission to allow enterprises or individuals to engage in businesses related to drugs and cosmetics.

No enterprise or individual can operate a business dealing in drugs, medicines or cosmetics without obtaining a drug license in India. In addition to a drug license, they must also obtain a trade license and a shop and establishment registration.

Scope and Regulation

The Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945, help the government regulate and monitor the quality of drugs sold in India. The government exercises control over drugs from:

• The raw material stage
• During manufacture
• Sale and distribution
• Till it reaches the patient or consumer via retail pharmacy, hospital, or dispensary

The government also exercises control over aspects such as:

• Import and export of medicines
• Sale of drugs to minors
• Consumption of Schedule H & X drugs

These regulations require thorough monitoring and cautious execution. The drug license is granted by the drug controlling authority under the Drugs and Cosmetics Act, 1940.

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Types of Drug License

In India, the following types of drug licenses are required depending on the nature of the drug business:

• Manufacturing License – License issued to a business that manufactures drugs inclusive of allopathic or homoeopathy medicines.
• Sale License – License issued for the sale of drugs, further categorized into:
  • Wholesale Drug License – Required for selling drugs to retailers for further sale.
  • Retail Drug License – Required for the sale of drugs or cosmetics to end consumers, hospitals, dispensaries, educational or research institutes.
• Loan License – For businesses that do not own a manufacturing unit but use facilities of another license holder.
• Import License – Required for dealers importing drugs or raw materials used for drug manufacturing.
• Multi-Drug License – For businesses with pharmacies in multiple states under the same name.

Drug Controlling Authority or Regulatory Authority

The drug controlling authority (also known as the licensing authority) under the Drugs and Cosmetics Act is responsible for issuing different types of drug licenses:

• State Drugs Standard Control Organisation (SDSCO) – Issues licenses for sale, distribution, and manufacture regulated by state authorities.
• Central Drugs Standard Control Organisation (CDSCO) – Responsible for licensing new drugs, clinical trials, import quality control, and coordination with SDSCO.
• State Drug Controlling Authority (with Central License Approving Authority’s approval) – Issues licenses for blood banks, vaccines, sera, and similar biological products.
• Department of Ayush – Issues licenses for Ayurvedic, Unani, Siddha, Homoeopathic, and herbal medicinal/cosmetic products.

Prerequisites for Obtaining a License

• Pharmacist / Competent Individual:
  • Retail: Must be a qualified pharmacist.
  • Wholesale: Graduate with 1-year experience or undergraduate with 4 years of experience.
• Space Requirement:
  • Wholesale & Retail: Minimum 15 sq. meters
  • Medical Retail Shop: Minimum 10 sq. meters
  • Height: As per National Building Code of India, 2005
• Storage Facility:
  • Refrigerators and cold storage required for temperature-sensitive drugs
• Technical Staff:
  • Retail: Must be knowledgeable and experienced
  • Wholesale: Graduate with 1 year or undergraduate with 4 years of experience

Application for a Drug License

The applicant must apply to the respective drug controlling authority depending on the type of license required. The process includes:

1. Visit the Respective Drug Controlling Authority Website:

   Choose SDSCO, CDSCO, or Ayush depending on the license type as each authority handles specific license categories.

Filing of Application

The applicant must file the drug license application online on the respective drug controlling authority website. The application form must be filled with accurate and complete details as requested.

Upload Documents

After completing the application form, the applicant must upload the necessary documents and submit the application along with the applicable fees. It is important to ensure that all documents are up to date before submission.

Visit by Drug Inspector

Once the application is submitted, a Drug Inspector will visit the applicant’s premises (shop, company, or drugstore) for the physical verification of the documents and the facts stated in the application form.

Grant of the Drug License

After successful inspection and verification, the Drug Controller will issue the drug license to the applicant.

List of Essential Documents for Obtaining a Drug Sale License

The following documents are required for applying for a sale license (wholesale or retail):

• Constitution of the entity:
  • Memorandum of Association (MOA)
  • Articles of Association (AOA) for a company
  • Partnership deed for partnership firm
  • LLP agreement for LLP
• ID proof of partner/director/proprietor
• Premises-related documents:
  • Ownership documents or rental agreement
  • No Objection Certificate (NOC) from the owner (if rented)
• Site plan and key plan of the premises
• Board resolution permitting obtaining of a license (for companies)
• Proof of availability of storage space such as refrigerator or cold storage
• Copy of challan as proof of fee payment
• Affidavit stating non-conviction of proprietor/partner/director and the firm
• Affidavit from the registered pharmacist/competent person
• Cover letter with the name and designation of the applicant
• Declaration form in prescribed format
• Applicant’s qualification certificate
• For a pharmacist at a retail outlet:
  • Proof of qualification
  • Registration certificate from local pharmacy council
  • Appointment letter
• For a pharmacist at a wholesale outlet:
  • Proof of qualification
  • Experience certificate
  • Appointment letter

List of Application Forms for Drug License

Frequently Asked Questions (FAQs) – Drug License in India

Frequently Asked Questions (FAQs) – Drug License & FDA/CDSCO in India