Drug Licence

[ Starting at 19,999/- Onwards ]

  • Application form in the prescribed format
  • Proof of ownership of the premises
  • Proof of constitution of the business (Incorporation Certificate / MOA / AOA / Partnership Deed)
  • KYCs of Directors / Partners / Proprietor
  • Covering Letter with the intent of the application signed with name and designation of the applicant
  • Key plan(Blue print) for the premises
  • Site plan (Blue print) for the premises
  • Affidavits as prescribed
  • Declaration form in the format prescribed
  • Additional documents as may be applicable on case to case basis.
Submit your Details
WHAT?

Drugs and medicines in India are regulated by the Drugs and Cosmetics Act, 1940. Any person who intends to manufacture, sale or distribute any type of Drugs or Pharma products or import any Drugs in India for the purpose of carrying out the business in pharmaceutical industry are required to obtain a License from the Government of India. The rules and regulations pertaining to drug license is governed by the Food Safety and Drug Administration Department of the concerned State Government.

WHY?
  • Mandatory under Drugs and Cosmetics Act, 1940
  • Separate License for different States
  • Areas and Storage conditions to be fulfilled before applying for the license
  • Ensures the tampering of the Drugs and medicines
  • Different Types of License for different Purpose
WHO?

Every person/entity engaged in the business of pharmaceuticals products are required to obtain different license for different categories.

The five main categories of licenses to be obtained:
IMPORT LICENSE
  1. Required for import of drugs and medicines
  2. Application in Form 8 (Form 8A for drungs mentioned in Schedule X of the precribed Act)
  3. Valid for 3 years
MANUFACTURE LICENSE
  1. Required for manufacture, sale, distribution of drugs or medicines
  2. Application in Form 40
  3. Valid for 3 Years
LICENSE FOR EXAMINATION, TEST, ANALYSIS
  1. Required for the import of drugs in small quantities used for the purpose of examination, testing and analysis
  2. Applicantion in Form 12
SALE LICENSE
  1. Required for the sale of Drugs and medicines
  2. Application in Form 19AA
  3. Valid for 5 Years
LOAN LICENSE
  1. Required in case an applicant intends to avail the manufacturing facilities owned by another licensee.
  2. Application in Form 24B
  3. Valid for 5 Years
HOW?
  • Step 1: Application Form :- Fill up the prescribed application form to be filed with the concerned authority.
  • Step 2: Documentation :- Provide the prescribed documents required to be submitted along with the application form.
  • Step 3: Application Submit :- Once the application form is complete, it will be filed with the Drug Control Department along with the prescribed fees depending upon the type of license required.
  • Step 4: Drug License :- Once the application is completely verified by the Department, certificate is issued in the name of the Applicant. The whole process takes 35-40 days to complete.
Penalty for Non-Registration
  • Imprisonment of Min 1 Year and Max 3 Years. In certain case for the Lifetime.
  • Penalty of Rs. 5,000/-
  • Confiscation of the stock.