Drug License
The Government of India has laid down several drug laws that regulates and control the manufacture and sale of drugs. The issuance of license for drugs is subject to conditions laid under Drugs and Cosmetic Act, 1940 and Rules, 1945. In order to pursue any business activity in relation to drugs, it is mandatory to obtain a valid drug license from competent state authority of drugs control department.
At E-tax, we remarkably deal with the licensing of entities that are engaged in the business of manufacturing or sale of drugs or medicine. Our range of service covers different types of drug licenses based of specified drug category. For any query in relation to grant of drug license, you can certainly consult the E-tax executives. We would be happy to help.
Scope of our Registration Services:- Drug Sale License
- Drug Manufacturing License
Documents for Drug Registration: (A) Sale License
- Site plan and key plan of the premise
- Identity proof of proprietor / partner / director
- Copy of challan as a proof of fees deposited
- Certificate evidencing registration or incorporation
- Address proof documents for owned or rented premises
- Proof of storage space as cold storage, air conditioner, refrigerator, etc
- Affidavit from the registered pharmacist/competent person
- Affidavit of non-conviction of Proprietor/Partner/Director and Firm/Company
- Affidavit of compliance of MPD 2021, if premises are located on DDA property
- Appointment Letter, Bio Data and Proof of qualification of registered pharmacist or competent person
- Experience Certificate of competent person for wholesale or Pharmacy Council Registration Certificate of pharmacist for retail
- Constitutional documents like Memorandum and Articles of Association/Partnership Deed/LLP Agreement/Trust Deed
(B) Manufacturing License:
- Site plan and key plan of the premise
- Copy of challan as a proof of fees deposited
- Certificate evidencing registration or incorporation
- No Objection Certificate from appropriate authorities
- Address proof documents for owned or rented premises
- List of Formulations with product information for each drug separately
- Affidavit about owner / user of the trade name
- Full time working affidavit from employer and technical staff
- Affidavit of Non Conviction as given in Guide Line Booklet
- Consent of Approved Testing Laboratory for sophisticated testing
- List of Equipment and Machineries for manufacturing and testing
- Constitutional documents like Memorandum and Articles of Association/Partnership Deed/LLP Agreement/Trust Deed
- List of Technical Staff in manufacturing and testing with self-certified copies of Education Qualification, Experience Certificate, Bio data, Appointment Letter, three photographs
Our Registration Process Inclusions:
- Registration related consultancy
- Compliance of license requirements
- Gathering information and documents
- Drafting of relevant documentations
- Preparation and submission of application
- Support for online or offline fee payment
- Procurement of Drug License