Drug License

Drug Licence in India

Drug license in India is a permission granted by the proficient authority under Drugs and Cosmetic Act, 1940 to start a business concerning Drugs / Medicines or Cosmetics. The license covers all types of drugs or cosmetics businesses such as Allopathic, Homeopathic, Ayurvedic, or Unani Drugs. In this article we will discuss the need of a Drug Licence and Drug License online  procedures in India.


What is the Meaning of Drugs?

Drug License in India is a kind of permission by the respective State Authority to the manufacturers, wholesalers, retailers, distributors and all others, who are engaged in the business of pharmaceuticals for carrying out the business activities related to the pharmaceutical industry.

According to Section 3(b) of the Drugs and Cosmetics Act, 1940 “Drugs” includes: –

  • All the Medicines and Devices, which are in the use of Human Beings or Animals Internally or Externally.
  • All Substances planned to be in used for the Diagnosis, Mitigation, Treatment, or Prevention of any disorder or disease in Human Beings or Animals.


How many types of Drug License in India?

Respective State Drug License Authority issues Drug License under the Drugs and Cosmetics Act, 1940. Drug License in India is mainly classified in 5 Broad Categories.

  • Manufacturing License
  • Sale License– Sale License can be obtained as follows –
    • Wholesale Drug License
    • Retail Drug License
    • Restricted Drugs License
  • Loan License
  • Import License
  • Multi-Drug License

What are the Conditions for Obtaining a Drug License?

  • Pharmacist or Competent Individual – In case of retailer Business, Individual should be pharmacist under the State Pharmacy Council. In case of a wholesale business, the individual should be a graduate with at least 1-year Experience or an undergraduate with 4 years of Experience.
  • Space Requirement –The other important condition is requirement of space. The minimum area required for pharmacy or unit is:
    • Space  – 15 square meters. (for both retail & Wholesale)
    • Rest for all other Cases – 10 square meters.
  • Storage Facility – It is mandatorily required to have an Air conditioner and Refrigerator on the premises,


What are the mandatory documents required for Drug License?

Essential documents required for obtaining Drug License in India are as under-

  • Constitution of business organization as for-
    • Company – Memorandum of Association (MOA) and Articles of Association (AOA) and a Copy of resolution Passed.
    • Partnership Firm – partnership deed, duly attested by Notary Public.
    • Trust / Society – Trust deed.
  • ID proof of Proprietor / Partner / Director.
  • An Affidavit regarding non-conviction of Proprietor/Partner/Director and the Firm.
  • Key plan along with the site plan of the premise.
  • Receipts of Online Fees Deposit.
  • Online Affidavit from the Registered Pharmacist or Competent Person.
  • Proof of availability of storage space as cold storage, refrigerator, etc.
  • For registered Retail Sale Pharmacist –
    • Qualification – Certificate of Final Degree / Provisional Certificate with Mark Sheets.
    • Registration of local Pharmacy Council.
    • Appointment Letter and Bio-data.
  • For registered whole sale Pharmacist –
    • Qualification – Final Degree / Provisional Certificate with Mark Sheets.
    • Experience Certificate
    • Appointment Letter and Bio-data.
  • Document Related to Premises:
    • If Owned:

Registered Sale Deed / Registered General Power of Attorney (GPA) / Transfer Deed in the name of owner or Unregistered Sale Deed / unregistered General Power of Attorney (GPA) supported with Electricity Bill / Water Bill / property tax receipt.

  • If Rented:

Rent receipt, Registered Rent Agreement, Unregistered Rent Agreement along with ownership documents of the Property Owner.


What is the Procedure for obtaining Drug License in India?

Drug License application Procedures-

  1. Applicant shall apply for the license online, as per the line of business.
  2. Fill the form and Upload the documents, as mentioned above.
  3. After uploading all the documents, requisite fees of the form should be paid & a Challan will be generated for further processing.
  4. DCO will send the report to the SDCO of the zone for granting the License.
  5. The authority will issue the Drug Licence.


 What is the validity of a Drug License in India?

In most of the cases, a Drug Licence in India is valid for 5 Years.


We have already discussed about the documents and procedure of obtaining Drug Licence. It is always would to take help of Experts. If you have any query regarding Drug Licence or you want to obtain this license, feel free to contact Manthan Experts at info@manthanexperts.com.

Knowledge Source:

MSME Registration in India – Procedure, Benefit

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