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License Procedure

Food and Drug Administration Haryana Grants Selling Licenses for Drugs as per the provisions of Drugs Cosmetics Act-1940. 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:-
  1. For Retail sale - 10 square meter.
  2. For Wholesale - 10 square meter.
  3. 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 online in the requisite Form viz 19, 19A,19B, 19AA details of Forms and pay Necessary fees as given in fee chart in Appendix A
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-
  1. 0210 - Medical and Public Health.
  2. 04 - Public Health.
  3. 104 - Fees and Fines, etc.
Documents to be uploaded along with the application form:
  1. Requisite Application Form.
  2. Receipt for the fees paid or challan, as the case may be or their attested copies.
  3. Layout plan of selling premises in 3 copies.
  4. Documents viz. rent receipt, purchase documents or its attested copies showing lawful possession of the premises.
  5. Documents relating to the constitution of the firm viz. Partnership-deed, memorandum and article of association etc.
  6. Full particulars of the competent technical staff /registered persons along with copies of their educational qualification, experience and registration certificates.
  7. 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.
  8. 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 for Retention of Drug Sale Licence

1.  Govt. of India vide its notification no. GSR-1337 dated 27.10.2017 has omitted the word "Renewal" and instead of renewal procedure of license retention by the licensee, “ïf the licensee deposits a license retention fee before the expiry of a period of every succeeding five years from the date of its issue, unless, it is suspended or cancelled by the Licensing Authority”.

2.  The license retention fee shall be equivalent to the respective fee required for the grant of such license excluding inspection fee paid for grant of license.

3.  If the licensee fails to pay license retention fee on or before the due date, he shall be liable to pay license retention fee along with a late fee calculated at the rate of two percent of the license fee for every month or part there of up to six months, and in the event of non-payment of such fee, the license shall be deemed to have been cancelled.

4.  Licensee at the time of submission of license retention fee should submit an undertaking that (a) there is no change in constitution (b) there is no change in premises (c) there is no change in approved technical staff (d) list of already approved items and required fee which firm intends to retain.

5.  Validity certificate on receipt of license retention fee shall be issued forthwith if full fee in all respect is deposited