Drug License
D rug License is essential to carry out drug, Medicine, Cosmetics business in India. The Central Drugs Standard Control Organization and State Drugs Standard Control Organization control the issue of drug license in India. Drug license for setting up a pharmacy business is usually under the purview of the State Drugs Standard Control Organization.
Regulation governing manufacture & sale of drugs are given in the Drugs and Cosmetics Act, 1940 and Rules framed thereunder. Control is exercised over drugs from the raw material stage during manufacture, sale, distribution and upto the time it is passed-on to a patient or consumer by a Pharmacist in retail Pharmacy, Hospital or a Dispensary.
Drug License is Mandatory for the Organisation engaged in Medicine and Pharmacy and therefore various provisions applicable on it so such Drug License should be as per provisions of the act otherwise such Non Compliance of these provisions lead to hefty fine, Penalty on the Management of organisation.
We, Compliance Hands, a team of more than 50 qualified professionals like CA, CS, Advocates etc, having experience of more than 5 years of handling tasks like this and have completed more than 2000 projects. We ensure all the compliance on time and you can carry on your business without any hiccups.
Drug License is mandatory to carry out the business of drugs, medicine, cosmetics products. There are 2 kind of sale drug license:
Retail Drug License-
Retail Drug License in India is issued by Licensing Authorities to retailers who are doing business in pharmaceuticals, stand-alone pharmacists, etc. The applicant should be registered pharmacist under the State Pharmacy Council.
Wholesale Drug License-
The wholesale Drug License in India is issued by CDSCO (Central Drugs Standard Control Organization) to those wholesalers who are doing business in pharmaceuticals. The person who wants to obtain this License must have some degree or diploma in pharmacy from a recognized university and a minimum of one year experience in drug dealing.
1. Copy of the Pan Card of the Company/Firm/LLP.
2. Self attested copy of, Bank Statement, Landline Bill, Power Connection Bill, water Bill in the name of the establishment, Any license/certificate/number issued by any Govt. authority etc., as address proof of the establishment.
3. In case of company Memorandum/Articles of Association/Partnership Deed.
4. ID, Address Proof,PAN, Mobile Number & E mail ID of all Directors/Partners.
5. Copy of registration certificate issued under Companies Act, Certified Copy of Resolution, GST, Shop & Establishment Registration etc
6. E-Mail id and Mobile number of the firm/company.
7. Application form duly filled and signed & Receipt of application fee deposit
8. Self-attested copy of the registered plant layout
9. Invoice of Refrigerator, AC for business purpose
10. Affidavit regarding non-conviction of Prop./Partner/Director as well as the firm under Drugs & Cosmetics Act, 1940.
Additional Documentation if applicant is Pharmacist
1. Copy for the diploma in pharmacy
2. Registration Certificate from The Pharmacy Council
3. Experience Letter, if any
4. Affidavit of pharmacist
5. Details of the educational certificate of a competent person
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Drug License are subject to State Govt there for documentation requirement may vary state to state.
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