Legal Requirements.pptx

Legal Requirements

1. LEGAL REQUIREMENTS FOR STARTING A DRUG STORE Dr. Ajith JS Asst. Professor Department of Pharmacology Sanjivani College of Pharmaceutical Education & Research, Kopargaon

2. INTRODUCTION The sale of drugs is quite different from the sale of other goods 1.Minimum Qualifications  A person who wishes to start a retail drug store should either be a registered pharmacist himself or should engage the services of a registered pharmacist. In order to become a Registered Pharmacist but in case of drugs, the choice is in the hands of a physician. ( i ) The person should have attained at least 18 years of age. (ii) He should be a resident of the state or should be carrying out his business or profession of pharmacy in the state. (iii) Should possess a degree of diploma in Pharmacy or any other approved qualification.

3. 2.Minimum Space : Adequate space is required for running a retail or wholesale drug store. The area should be equipped with proper storage facility for preserving the properties of drugs to the license applies. For the storage of thermo labile substances such as vaccines, sera, enzymatic  preparations, antibiotics, vitamins, etc , a refrigerator is required in order to store these drugs at a temperature be at °C . There should be sufficient number of storage racks for storing the drugs and Pharmaceuticals case of a Pharmacy , the requirements as specified in Schedule Drugs and Cosmetics Act should be fulfilled.

4. 3.Application for Grant of License categories : (I) Drugs specified in. Schedule C and C1 to the Drugs & Cosmetics Act. (ii) Drugs specified in Schedule X to the Drugs & Cosmetics Act. (iii) Drugs other than those specified in Schedule C, C1 and X. The retail and wholesale licenses are granted with respect to all the above three categories. Any person desirous of getting a license to sell, stock, exhibit or offer for sale or distribute the drugs should apply to the licensing

5. 4.Conditions of Licence  The licensee for the sale of drugs are granted based on certain conditions including the following :  ( i ) The licensee shall be displayed in a prominent place in a part of the premises open to the public.  (ii) The licensee shall comply with the provisions of the Drugs and Cosmetics Act, 1945 and Rules there under for the time being in force.  (iii) No drug, shall be sold unless such drug is purchased under cash or credit memo from a duly licensed dealer or a duly licensed manufacturer. (iv) No Physician's Sample (not for sale) or expired drugs will be stocked on the sale premises.  However. expired drugs may be kept in separate packages or carton, the top of which shall display prominently the words 'Not for Sale'. 

6. (v) No drug belonging to CGHS , Armed Forces Medical store or a Government Hospital shall be present in the licensed premises.  (vi) In case of Pharmacy, the compounding of the prescription would be done under the personal supervision of a Qualified Person.  (vii) All registers and records required to be maintained under the Act would be preserved for a period of at least 2 years from the date of the last entry therein.  viii) The license will be renewed as and when required.  (ix) Any change in ownership or "Qualified person" shall be notified to the licensing authority within  three months.

7. 6. Duration of Licensee: A license for the sale of drugs remains valid upto 31st December of the year following the year  ill which the licensee is  granted or renewed.

8. 7.Renewal of License :   Application for the renewal of the license may be made before the expiry or within six months of the date of its expiry, along with late fees . The license shall be deemed to have expired if the application for renewal of license is not made within six months after its expiry . In the event of do change in constitution of a licensed firm, the licensee shall inform the licensing of change unless in the authority. Licenses of such firms are deemed to be valid for a period of three months from the date meantime a fresh license has been obtained.