Counterfeit monitoring licensing

transcript

Republic of the PhilippinesDepartment of Health

Food and Drug Administration

Counterfeit Monitoring

Product Research and Standards Development DivisionCenter for Drug Regulation and Research

Presentation Outline

• Counterfeit Medicines• Current Legislation on Counterfeit

medicines• Local incidence• Product Verification Process

What are counterfeit drugs?

World Health Organization (SSFFC)SubstandardSpuriousFalsely LabeledFalsified andCounterfeit Medical Products

It is a drug which is deliberately and fraudulently mislabeled with respect to identity and/or source. (World Health Organization)

(World Health Organization)

correct ingredients wrong ingredients

without active ingredientsinsufficient ingredients

fake packaging (World Health Organization)

Current Legislation on Counterfeit medicines

Republic Act No. 8203

Special Law on Counterfeit Drugs• Enacted on 06 September 1996• Effective on 27 October 1996

Generally prohibits activities related to the importation, manufacture, sale, distribution or mere possession of “counterfeit drugs”

Refers to medicinal products

correct ingredients but not in the amounts as provided

wrong ingredientswithout active ingredients

insufficient quantity of active ingredient reduction of the drug’s safety, efficacy, quality, strength or

purity

Counterfeit drug/medicine

Counterfeit drug/medicineBearing without authorization the trademark, trade name or other identification mark or imprint or any likeness to that which is owned or registered in the Bureau of Patent, Trademark and Technology Transfer (BPTTT) in the name of another natural or juridical person

refilled in containers by unauthorized persons if the legitimate labels or marks are used;

Counterfeit drug/medicinean unregistered imported drug product (with registered counterpart brand in the Philippines)

EXCEPT drugs brought in the country for personal use as confirmed and justified by accompanying medical records

a drug which contains no amount of or a different active ingredient or less than eighty percent (80%) of the active ingredient it purports to possess as distinguished from an adulterated drug including reduction or loss or efficacy due to expiration.

Manufacture, sale, or offering for sale, donation, distribution, trafficking, brokering, exportation, or importation

Prohibited Acts

Possession of any such counterfeit drugs

Prohibited Acts

Forging, counterfeiting, simulating or falsely representing, or without proper authority, using any mark, stamp, tag, label or other identification mark or device authorized or required by Republic Act No. 3720

Prohibited Acts

• Manufacturer, exporter or importer of the counterfeit drugs and their agents

• The seller, distributor, trafficker, broker or donor and their agents• The possessor of counterfeit drugs • The manager, operator or lessee of the laboratory or laboratory

facilities • The owner, proprietor, administrator or manager of the drugstore,

hospital pharmacy or dispensary, laboratory or other outlets or premises

• The registered pharmacist of the outlet where the counterfeit drug is sold or found, who sells or dispenses such drug to a third party and who has actual or constructive knowledge that said drug is counterfeit

Parties Liable

Any person may file a complaint

IRR of 8203RULE IV: PROCEDURE IN THE FILING OF ADMINISTRATIVE COMPLAINT

Filing Of Administrative Complaint

Brand owner

Affidavit of complaint

Consumer

Letter of complaint

Submitted together with samples

Letter of complaint–Name of product–Source or the name and address of the

person from whom the product was acquired–Mode of acquisition–Reason or fact giving rise to the suspicion

Filing of Administrative Complaint

Local Incidence

Commonly counterfeited• Popular medicines with high demand– Antihypertensive, Antibiotics

Local incidence

Local incidence• Lifestyle medicines

- slimming products- products for erectile dysfunction containing ingredients

present in Viagra or Cialis

• Patented medicines

Local incidence

• Leading branded-generic medicines in the market

Local incidence

Unregistered Drugs

• Licensing requirements for drug establishments

• Post market surveillance and enforcement

• Internal Collaboration (CDRR, RFO, CHDs, LSSC, REU)

• In-house lab testing of drug products

Strategies in place

• Collaboration with local enforcement agencies (PNP/NBI/CIDG)

• Collaboration with stakeholders/companies

• International collaboration (ASEAN, WHO, Interpol)

• Consumer advisories to increase public awareness

Strategies in place

• Active Surveillance– Stimulated reporting (Enforcement agencies)– Data gathering (FDA Routine PMS)

• Passive Surveillance– Consumer/Stakeholders Complaints

Source of Reports for Suspected Counterfeit Drug Products

Verification of Suspected Counterfeit Products

Suspected Counterfeit Products

1• Collection/Receipt

2• Evaluation

3• Enforcement Action

Sources: • FROO, CHDs• PNP/NBI• Reports from Concerned Citizen• Reports from company• Central Laboratory

1• Collection/Receipt of Report

Referral Letter + Sample

What are the necessary information? • Information on Samples : –Name–No. of samples submitted – Batch No./ Lot No. –Manufacturer/Distributor –Date of Manufacture – Expiry date

Submission of Reports

What are the necessary information? • Name of Source• Location/Address• Sales invoice/Official documents• If available–Date of sampling –Requesting Officer

Submission of Reports

Center for Drug Regulation and Research

2•Evaluation

References– Republic Act 8203

– Administrative Order No. 55 s. 1988

– Department Circular No. 2011 – 0101

– Product Dossier

Evaluation of Suspected Counterfeit Product

Referral Letter + Sample

Validate the information

Physical Evaluation

Can conclude?

Certification

Verify from MAH

Laboratory AnalysisYes

Section 3 of the IRR of RA 8203The Center [Regulation Division I] may also require the registered brand-owner of the

suspected counterfeit drug to certify whether or not the suspected drug product has been manufactured, imported and/or distributed by them; or whether they own the Lot Number and Expiry Date of the same suspected drug product. The certification issued by the registered brand-owner shall be supported by the batch, production and distribution records. However, the brand-owner's certification shall be validated for evidentiary purpose.

Evaluation of Suspected Counterfeit Product

Verify from MAH

Evaluation Results• Unregistered drug product

• Unregistered with registered counterpart brand

• Counterfeit drug product40

2•Evaluation

Evaluation Results• Registered and compliant to approved label/

labeling requirements

• Registered but non-compliant to approved label/ labeling requirements

• Out of specifications

2•Evaluation

Most common signs that a medicine is unregistered:

2•Evaluation

purchased in an unlicensed outlet/establishment and was not issued with an official receipt

no name and address of any drug establishment licensed in the Philippines

no drug registration number

foreign markings

Basis:• Republic Act No. 3720: Food, Drug, and

Cosmetic Act• Administrative Order No. 55 s. 1988• Bureau Circular No. 05 s. 1997

Generic Labeling Exemption

Grounds:• Administrative Order No. 55 s. 1988– Primary pack is enclosed in transparent covering

and the particulars are clearly visible– Compounded by a pharmacist– Investigational Products– Donated Products

Grounds:• Bureau Circular No. 05 s. 1997– Service item– Specially packed– Low volume of importation• < 500 units/ month or 6000 units/ yr

– Drug product requires special handling

2•Evaluation

• Appropriate Administrative Sanctions

• Closure of Case

FROO - RFOREULSSC

3•Enforcement Action

National Consciousness Week Against

Counterfeit Medicines

16 – 20 November 2015

Presidential Proclamation No. 2082 dated 15 June 2010

Mamamayan Makialam, Pekeng Gamot Labanan.

Thank you!

Counterfeit monitoring licensing

Health & Medicine