Drug License

What is Drug License?

The Drug License is an official permission granted by the government to deal with drugs in India. It comes in two forms, retail and wholesale, for the distribution or sale of drugs. The license is issued based on certain conditions that are applicable to the premises and the competent person responsible for dealing with drugs.

According to the Drugs and Cosmetics Act of 1940, a drug license is mandatory for any person or entity looking to conduct a business involving drugs, medicines, or cosmetics in India. This applies to all types of drugs, including allopathic, homeopathic, ayurvedic, or unani drugs. The responsibility of maintaining the quality of drugs and cosmetics lies with all individuals involved in their production and distribution.

It is important to note that any harm caused to a person consuming or using a drug or cosmetic due to negligence on the part of the manufacturer or seller is considered a serious offence. Such cases are tried under the Indian Penal Code as offences of grievous hurt.

Rietway Consultants Drug License Package

The Services which are included in our package are as Follows:
✅ Consultation for Type of license required
✅ Preparation of Documents
✅Application Filing
✅Paying Government Fees
✅ Drug License

Documents required to obtain Drug License

o apply for a drug license in India, the following documents must be submitted along with the application form:

  1. Memorandum of Association/Articles of Association to establish the firm’s constitution.
  2. A valid photo ID proof of the proprietor, partner, or director.
  3. Copy of the property papers, if the property is owned by the applicant.
  4. Copy of the rent agreement, if the property is rented.
  5. Site plan and key plan of the premises where the drugs will be stored or sold.
  6. Invoice and details of the refrigerator used for drug storage.
  7. An affidavit stating compliance with the Master Plan of Delhi 2021, if the premises are situated in a DDA residential flat/plot/building.

These documents are mandatory for obtaining a drug license, and must be provided in order to carry out a business that involves dealing with drugs or cosmetics in India. It is the responsibility of all persons involved in the distribution of drugs and cosmetics to ensure their quality, and failure to do so may result in legal consequences.


Additional document for Retail Sale Registered Pharmacist
1. Proof of qualification i.e. final degree certificate/provisional certificate with mark sheets
2. Registration of Delhi Pharmacy Council
3. Appointment Letter and Bio-data

Additional document for Wholesale Licence Competent person
1. Proof of qualification i.e. final degree certificate/provisional certificate with mark sheets
2. Experience Certificate
3. Appointment Letter and Bio-data

Drug License procedure

Step 1: Documentation: The most important step in obtaining the drug License is the preparation of documents which includes, preparation of key plan and site plan and various affidavits and declaration as prescribed under law.
Step 2: Application Filing: The Drug License applications are filed online, these days including the payment of government fee. All documents are scanned and uploaded at the time of filing the application. However, filed documents are verified by the inspector.
Step 3: Inspector: Visit After the application for grant of drug license is filed, the same is marked for inspection and thereafter the drug inspector personally visits the shop to verify the documents and correctness of information.
Step-4: Grant Of License: After the Inspection is complete and in case personal interview is called for is cleared by the competent person and upon verification all information and documents furnished is correct the controller of drugs issues the Drug License.

Conditions for obtaining Drug License

To obtain a retail or wholesale drug licence, the applicant must provide an independent shop with a sufficient area as specified below:

  • For a licence in Form 20 or Form 21 or both, the premises must be at least 10 square metres in area.
  • For a licence in Form 20-B or Form 21-B or both, the premises must be at least 10 square metres in area.
  • For a licence in Form 20 or Form 21 or both and in Form 20-B or Form 21-B or both, the premises must be at least 15 square metres in area.

The height of the sales premises must comply with the National Building Code of India, 2005 and its amendments.

Drug licences are not granted for premises situated on a DDA allotted residential plot/land or flat unless they meet the requirements of MPD-2021.

FAQ on Drug License

Is it necessary to obtain a drug license prior to commencement of the drug business?
Yes, before you start any business dealing in drugs, whether it is Allopathic Drugs, Ayurvedic Medicine, Homeopathy or Unani, to manufacture, distribute or sell the drugs It is mandatory to obtain a license as per the nature of business by applying to the controller of the drugs and cosmetics.

Is it true that for grant of a drug license my shop must be located at a commercial premise?
Licenses for the sale of drugs can be granted only at premises which is commercial premises or other premises independent of residence, also known as mixed land use. For this purpose, state drug office issues guidance which may be referred to.

What are different types of Licenses Issued for the Pharmaceutical Business?
i. rug Manufacturing License,
ii. Wholesale Drug License,
iii. Retail Drug License,
iv. Import of Drugs or Cosmetics,
v. Import of Medical Equipment,
vi. Export of Medicine

Do I have to apply and seek separate drug license for Branches of My Pharmaceutical Business?
In case a business is operating in more than two states, it has to obtain drug license in every state in which business is being carried on. Drug licence is location specific, and hence within state application, all site must be included.

How to import Drugs or Cosmetics ?
Drugs and Cosmetic Act aims at ensuring safety, effectiveness and conformity of the drugs and cosmetics sold in India to the state quality standards. Drugs or cosmetics of schedule can be imported into India only after obtaining a License.