THE FOLLOWING PROCEDURE MAY BE USED TO OBTAIN THE DRUG LICENCE FOR THE SALE OF DRUGS GENERALLY .....
A. Requirement of documents for grant of Licences for sale of drugs. 1.Application forms.
2. Chalan of fee deposited. 3. Declaration form. 4. Key plan (Blue print) 5. Site plan (Blue print)
6. Basis of possession of the premises.
7. Proof of ownership of the premises, if rented. 8. Proof of constitution of the firm (Certified copy) 9. Affidavit of non-conviction of Proprietor/Partners/Directors under Drugs & Cosmetics Act, 1940. 10. Certified copy of Regn. Certificate of MEDICAL Pharmacy Council/Experience 11. Certificate of the Registered Pharmacist/Competent person and qualification certificates. 12. Bio-data form. Affidavit of Registered Pharmacist/Competent person regarding fulltime working with the firm duly attested by Notary. 13. Appointment letter of Registered Pharmacist/Competent person in charge, if employed person.
23 November 2012
FOR GRANT OF DRUG LICENCE FOLLOWING FORMS UNDER DRUG AND COSMETICS ACT 1940 ARE TO BE FILLED UP ..............AND FOLLOWING REQUIREMENTS ARE TO BE FULFILLED ....
For the sale of Allopathic, Homeopathic drugs in Form 20, 21, 20B, 21B, 20A, 21A, 20C, 20D, 20F, 20G, 20BB,21BB.
For the sale of Ayurvedic Drugs and Cosmetics no sale licence is required.
The Requirements of Sales premises are as follows: Minimum carpet area:- For Retail sale - 10 square meter For Wholesale - 10 square meter For Retail - Wholesale together - 15 square meter
Storage facilities
Adequate storage facilities including cupboards with glass doors, racks refrigerator is required.
Procedure to obtain Drug Selling Licence(Fresh)
Stage1
Application for grant of Selling Licence The applicant has to make application in the requisite Form viz 19, 19A,19B, 19AA details of Forms and pay
Fee can be paid in cash at Head Office/Division as well as any other District Officer. The fee can also be paid through challan at Government Treasury, Reserve bank of India, State Bank of India and State Bank of Hyderabad for Maratha Wada Region under Head of Account-
0210 - Medical and Public Health. 04 - Public Health 104 - Fees and Fines, etc. Documents to be attached along with the application form:
Requisite Application Form.
Receipt for the fees paid or challan, as the case may be or their attested copies.
Layout plan of selling premises in 3 copies.
Documents viz. rent receipt, purchase documents or its attested copies showing lawful possession of the premises.
Documents relating to the constitution of the firm viz. Partnership-deed, memorandum and article of association etc.
Full particulars of the competent technical staff /registered persons along with copies of their educational qualification, experience and registration certificates.
Full name of the proprietor or the partners, as the case may be shall be provided in the application. In case of private or public limited concerns, full name of the Directors who sign the application and the authorised signatory, if any , shall be provided in the application.
Documents for the purchase of Refrigerator/Deep freezer (For Vaccines / Sera).
Stage 2
Inspection
The application is scrutinized and premises inspected.
Stage 3
Grant of Licence
If all conditions as prescribed by the act are complied licence is granted.
Procedure to Renew Drug Selling Licence Licenses in Forms 20, 21, 20B, 21B, 20A, 21A, 20C, 20D, 20F, 20G, 20BB, 21BB be renewed.
Stage 1 Application for renewal of Drug Selling Licence The applicant has to make application in the requisite Form 19, 19A, 19B, 19AA and pay Necessary fees as given in fee chart in Appendix A The mode of payment of fees is same as fresh licence.
Documents to be enclosed along with application of renewal of licence :-
Copy of cash receipt or challan for payment of fees.
Xerox copy of Licence /Previous renewal certificate.
Documents viz. rent receipt, purchase documents or its attested copies showing lawful possession of the premises.
Full particulars of the competent technical staff /registered persons along with copies of their educational qualification, experience and registration certificates.
Stage 2
Inspection
The application is scrutinized and premises inspected .
Stage 3
Grant of Licence
If all conditions as prescribed by the act are complied licence is granted
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