Drug License
Deliverables - Documents Required - Timeline
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Deliverables
Drug License
Licenses and Compliance Documents
Customs or Legal Documentation
Documents Required For Partnership Firm Registration
- Constitution of the entity, Memorandum of Association (MOA), Articles of Association (AOA) for a company, partnership deed, LLP agreement in case of partnership and LLP
- ID proof of partner/director/proprietor
- Documents related to premises – Copy of ownership documents of property or rental agreement and NOC (No Objection Certificate) from the owner of the rented premises as the case may be
- Site plan and key plan of the premises
- Copy of Board resolution permitting obtaining of a license
- Affidavit regarding non-conviction of proprietor/partner/director and the firm
- Proof of availability of storage space as cold storage, refrigerator, etc.
- Applicant’s qualification certificate
Timeline
30 Days
(from receipt of all documents)
Step 1
Filing Of Application online on the respective drug controlling authority website. The applicant must fill all the details asked in the application form.
Step 2
Uploading Documents along with the applicable fees.
Step 3
Visit by drug inspector : After receiving the application form, the drug Inspector will personally visit the company premises, shop or the drugstore for the verification of documents and correctness of facts stated in the application.
Step 4
Grant of the drug license.
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FAQs
A Food and Drug Administration (FDA) license is a license obtained under the Federal Food and Drugs Act. The Food, Drug and Cosmetic Administration (FDA), established in 1906, is a government agency under the Federal Food, Drugs and Cosmetic Act for consumer protection. The FDA license or certification is mandatory for placing food, drug, cosmetics and medical products in the USA.
Drug license verification can be done online through the respective state’s drug authority website. You need to enter the unique drug license number to verify the details of the drug license on the website.
The application fees for obtaining a license vary from Rs.1,500 to 500 depending on the type of application. However, there may be additional charges that the applicant needs to pay for obtaining lab tests, tests or analysis by the Central Drugs Laboratories or State Drugs Laboratories or test or analysis by the Pharmacopoeial Laboratory for Indian Medicine (PLIM) or the government analyst for obtaining the license. The Drugs and Cosmetics Rules, 1945 prescribes the fees for every license application and different tests for different products.
