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Checklist & Procedure for Retail Drug License (Homeopathy)

Checklist & Procedure for Retail Drug License (Homeopathy)

Legal & Compliance

Anil Ganga

Anil Ganga

12 Jun 2021, 11:00 — 5 min read

The government has stringent rules for granting license for selling of drugs and medicine. Examining the procedure for procuring a Homeopathy drug license.

 

Application: As per the Drugs and Cosmetics Act – 1940 and Rules made there under, online application shall be filed in Form 19-B with all annexures as follows to State Government at "Online Drug Licensing System" retail sale license. 

 

Application Fee / Online Challan: Rs 3000/- for each license (for each outlet) by net banking. 

 

Annexures to Application

1. Declaration by the proprietor / Partner / Director / Competent Persons / Regd. Pharmacist with proof of residential address (Present and Permanent) for proof of residential address – Aadhar Card, Ration Card, Pass Port, Driving License, Voter ID.

2. Attested copy of partnership deed (on Rs 500/- stamp paper) / Memorandum and Articles of Association.

3. Copy of list of Directors downloaded from ROC website signed by Company Secretary / Managing Director (In case of company).

4. In case of company an Affidavit under Section 34 of Drugs and Cosmetics Act, 1940 on Rs.20/- stamp paper duly notarized along with copy of its board resolution to this effect signed by company Secretary or Managing Director or Majority of the Directors of the company.

5. Special declaration by Registered Pharmacist on Rs 20/- non-judicial stamp paper.

6. Attested copy of Registered Pharmacist certificate (renewal up to date) affixed with latest original photograph and signature of the candidate / original to be produced to the Drugs Inspector at the time of inspection for endorsement.

7. Original plan of the premises indicating the carpet area (specifying length and breadth in meters and area in Sq.m) by the Licensed Draftsman / Planner along with the signature of Building owner and the applicant (Prop/ partners / Authorized signatory / Managing Director, etc,.) in a legal size.

8. Original declaration of building owner attested by Gazetted officer (Photograph of the building owner to be attested by the Gazetted officer).

9. Attested photocopy of the document showing the proof of ownership of the building owner for the premises to be licensed (E.C / any other legal document showing the present ownership.

 

Timelines: Approximately 14 Days from the date of Application

 

Conditions of license  License in Form 20-C or 20-D shall be subject to the conditions stated therein and to the following further conditions, namely:- 

(1). The premises where the Homeopathic medicines are stocked for sale or sold are maintained in a clean condition. 

(2). The Sale of Homeopathic medicines shall be conducted under the supervision of a person, competent to deal in Homeopathic medicines. 

(3). The licensee shall permit an Inspector to inspect the premises and furnish such information as he may require for ascertaining whether the provisions of the Act and the Rules made thereunder have been observed. 

(4). The licensee in Form 20-D shall maintain records of purchases and sale of Homeopathic medicines containing alcohol together with names and addresses of parties to whom sold. 

(5). The licensee in Form 20-C shall maintain records of purchases and sale of Homeopathic medicines containing alcohol. No records of sale in respect of Homeopathic potentised preparations in containers of 30 ml or lower capacity and in respect of mother tinctures made up in quantities up to 60 ml, need be maintained.

(6). The license shall maintain an Inspection Book in Form 35 to enable an inspector to record his impressions and the defects noticed.

 

Also read: Pharma packaging is moving toward customer-centricity

 

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Image source: shutterstock.com

 

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Anil Kumar Ganga

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