Saturday, 20 October 2012

How to Put-up a Drugstore Business in the Philippines

CONSIDERATIONS
To start-up a drugstore business in the Philippines many things are to be considered. They are:
  1. Location - You should have a very good prospective place to establish your drugstore. As in marketing, strategies of pointing out the volume of the consumers in the area is very important, because they are your target clients who might be the buyer in the future. Also the nearby establishments are being considered. Nearby hospital premise is a very excellent location for your drugstore, where patient-consumers are directly go to your drugstore to purchase drugs. In the market place is also a possible place to put up your drugstore, because people tend to procure medicines at the same time as they are buying food, vegetables, fish and alike. Inside the mall, wherein one-stop-shop is the business.
  2. You must have a REGISTERED PHARMACIST - He is the important person to be hired. Without him, your drugstore business will not operate. He must be licensed by the Professional Regulation Commission (PRC) of Board of Pharmacy through passing the Philippine Licensure Exam for Pharmacists which needed to be enlisted among the registered professionals.
  3. Secure Certificate of Business Name Registration (DTI, SEC or CDA), Business Permits and must be registered to Bureau of Internal Revenue (BIR) for taxes, and Franchise Agreement if franchised.
  4. Food and Drug Administration's (FDA) approval granting the License to Operate as a Drugstore.
REQUIREMENTS:
  • Drugstore's floor plan should not be less than 15 square meters, and must have sink with faucet and comfort room which is optional. Signage and signboard, containing the name of your drugstore, should be readable up to 20 meters. Floor must be tiled or concrete but not raw soil.
  • Pharmacist should photocopy his/her PRC ID, Board Certificate, PTR, 2x2 picture (for application), and including the certificate of Attendance for Licesnsing a Drugstore or AO 56 which a seminar conducted by FDA in different places and schedules. Original copy should be brought for verification when the FDA inspection is being made.
  • Availability of Reference Materials, which are latest edition, and Law abiding such as 
  1. Philippine National Drug Formulary, USP/NF
  2.  Remington: The Science and Practice of Pharmacy
  3.  Goodman and Gilman's: the Pharmacological Basis of Therapeutics
  4.  Medi-media Index of Medical Specialities or Physicians' Desk Reference 
  5.  RA 3720
  6.  RA 6675,
  7.  RA 5921
  8.  RA 8203
  9.  RA 9502
  10. AO # 56 s. 1989, EO # 821
  11. Advisory Council for Price Regulation # 2009-001 (GMAP)
  12. RA 9711
  •  Other requirements:
    1. Record books like Prescription Book, Senior Citizen's book, Disabled book. 
    2. Menu Card (Generics, MDRP, GMAP)
    3. Tablet counter, Graduated Cylinder
    4.  Generic Dispensing Flow Chart
    5.  Temperature monitoring facility and Air conditioning appliance (optional, provided that temperature does not exceed 30 C
    6.  Rubber stamp of the drugstore

APPLICATION TO FDA

Upon completing the checklist (downloadable in FDA's website) of requirements for drugstore, you are ready to apply your drugstore for FDA license. You should accomplished first the Petion Form and Joint Affidavit of Undertaking duly notarized, downloadable in the FDA's website or available in FDA main office. The application folder you will submit should be color yellow in two sets, and arranged according to the checklist provided. FDA has a pattern to follow in arranging the documents in the folder, a coupon bond is being place each before the next document. Eartag is placed on each paper bond to introduce the next document. The arrangement follows like this with paper bond before each document:

Basic Checklist on How to open a drugstore in Philippines 
  1. Petition Form (notarized)
  2. Joint Affidavit of Undertaking (notarized)
  3. Tentative list of Products using Generic and Brand names
  4. Generic White Label and Red Lable
  5. Rubber Stamp of Outlets
  6. Picture of drugstore with Signboard
  7. *Copies of Pharmacist Board Certificate, PRC ID, valid PTR, 1 (2x2) ID Picture, Duties and Responsibilities of the pharmacist and Certificate of Attendance of Owner/Pharmacist to a FDA sponsored/accredited Seminar on Licensing of Drug Establishments and Outlets.
  8. *DTI Registration (for Single Proprietorship), or SEC (for Corporation or Partnership), or CDA (for Cooperative)
    • If the Corporate Name is different from the Business Name, secure Business Name registration with DTI
    • If the Corporate Address is different from the Business Address, secure either Mayor's Permit or registration with DTI reflecting the Business Address.
    • If Franchisee, submit copy of Franchise Agreement 
  9. *Contract of Lease for the space occupied if not owned, or any proof of ownership if owned or notarized Certificate of  Occupancy
  10. Sketch of Location (Should be 15 sq meter at least)
  11. Sketch of Floor Plan 
* Bring Original Copies for verification

Your application will be submit to the Drug window and given you a clearance form for pharmacist to be filled up by pharmacist and submitted and cleared in Regulation Division II. When pharmacist is cleared, an interview will be held. The interview is regarding your application and the place of your business which last for about 15 minutes. After interview, the interviewer let you pay a licensing fee base on AO #50 s. 2001 for opening/initial which is valid for one year and amounting of PhP1010.00, inclusive of 1% miscellaneous fee, returning the duplicate copy to the interviewer..The last thing to do in your application is asking for the name of the officer-in-charged to evaluate your drugstore and ask, then, the contact number for communication.

EVALUATION AND INSPECTION PROPER

When the schedule date of evaluation comes, the pharmacist should be present in the meeting and inspection with/without the owner. The FDRO will thoroughly scrutinize each requirement and see to it that all the requirements are available, genuine and passed each of them. Especially the pharmacist's papers, floor plan, signboard, reference materials, apparatuses, facilities, books and the certificate of registrations and permits. Sometimes the FDRO will interrogate the owner or pharmacist about the opening and requirements, causing them to tremble and nervous. If there will be no deficiencies the inspector will note on the evaluation sheet "for issuance of License to Operate" and wait for the time when the Certificate of License to Operate as a Drugstore is available.The duplicate of his/her report should be given to you as a proof of inspection and approval. You can call the Releasing office or visit them in their office in FDA located at Civic Drive, Filinvest, Alabang, Muntinlupa City  to update if your LTO is available already. If deficiencies are present the owner and the pharmacist should comply and complete them.

PROBLEMS AND CONTROVERSIES
  • Long waiting for the releasing of the LTO that does not coincide with the maximum prescribe issuance of it which is 5 days from the time of inspection.
  • The inspector could not be contact or often out of office causing of defer and delay of operation of the drugstore.
  • The FDRO does not make it to the time of inspection, rescheduling of the inspection that causing delay again.
  • Incomplete requirements and presence of deficiencies that must be fixed as soon as possible.
  • Can not contact the trunkline of FDA, if ever you made it, no answering the phone or the person you are looking is not available.
  • Not organized in their processing of papers.
  • Invalid land area.
  • Pharmacist's requirements are not available.
  • Asking for other requirements that are not much connected to the drugstore.
  • Inspectors are being bribed and accepted gifts which they do not usually. (But this is really happening, we might not know)
  • Purchased drugs without the LTO from FDA to procure drugs leading to non issuance and disapproval  



  
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