importation of unregistered drug products · sigmapharm labs llc. list of products drug company*...

Republic of the Philippines Department of Health

Food and Drug Administration

Importation of Unregistered Drug Products

Center for Drug Regulation and Research


I. Food and Drug Administration

II. Use of Unregistered Products

III. Issues for Discussion

Presentation Outline

5 May 2015 2

Discuss and solicit comments from stakeholders on issues arising from the importation of unregistered drug products

Objective

To ensure the safety, efficacy, purity, and quality of products we regulate through effective implementation of the national regulatory framework consistent with international best practice

MISSION 5

To be an internationally recognized center of regulatory excellence safeguarding the health of the Filipinos

VISION 6

QUALITY POLICY

Our highest commitment is to ensure the safety, efficacy and quality of health products.

Toward this end, we commit to establish science-based standards as basis for regulatory policies, to continually improve and maintain our competencies in relation to our regulatory function, and to deliver quality public service with integrity.

7

Regulatory Framework Elements

1. Licensing/Accreditation of establishments • GMP, GDP, GSP, GCP, and GLP

2. Pre-marketing assessment • Quality, safety, and efficacy (for innovative medicines)

• Quality+interchangeability (for generics)

3. Post-marketing surveillance • Safety (benefit/risk balance)

• Quality (quality testing and compliance monitoring)

4. Communication 8

1. Pharmacovigilance

• Safety monitoring of drugs on the market for unexpected health risks and informing the public of risks posed by specific drugs and other health products;

2. Monitoring, collecting, sampling and testing of drugs

3. Audits and inspection of manufacturers/ distributors/ retail outlets

4. Advertisements and claims monitoring

5. Consumer reporting of ADR

6. Product recall / Administrative sanctions

Post-Marketing Surveillance 9

• Regulatory safeguards are in place to protect the public

• Licensing of establishments, registration of products, and post licensing and post marketing surveillance

Summary..



Use of Unregistered Products

k)a, Sec. 1 General Provision, Article I, Book II

IRR of RA 9711

• FDA recognizes the need for drugs and devices product/preparation which are not registered or are in the process of registration in the Philippines by patients who are terminally or seriously ill.

• Access to these products for these patients is morally, socially and ethically justified when there is no existing superior alternative therapy that can likely cure or adequately control their conditions.

5 May 2015 13

Administrative Order No. 4 s. 1992

5 May 2015 14

AO No. 4 s. 1992

Compassionate Special Permit for Restricted Use of Unregistered Drug and Devices Product (CSP)

• a special permit signed by the FDA Director granting a Specialized Institution (SI) and Specialty Society (SS) the privilege to avail of an unregistered drug and device product through a certain licensed establishment for certain kind/type of patients, specific volume and period.

15 5 May 2015

AO No. 4 s. 1992

• For patients suffering from the following conditions:

1. Acquired Immune Deficiency Syndrome (AIDS)

2. Cancer

3. Life-threatening conditions

5 May 2015 16

Application shall include:

• estimated volume needed

• the licensed drug/ device establishment through which the unregistered drug may be procured

• identify the names and address of the specialists qualified and authorized to use the product

AO No. 4 s. 1992 5 May 2015 17

Drug

Quantity requested per year Frequency of request

2013 2014 Total 2013 2014 Total

Colistimethate Na 1 M Unit vial 7600 37170 44770 13 23 36

Dipyridamole 10mg/2ml ampoule 10333 16382 26715 12 18 30

Glyceryl trinitrate 10mg/10ml amp 14990 9319 24309 8 20 28

Protamine sulfate 50mg/5ml vial 11475 6691 18166 13 22 35

Vasopressin 20 units/ml vial 4425 6895 11320 10 14 24

Adenosine 6mg/2ml vial 3963 5605 9568 15 30 45

Phenylephrine 1% 10mg/1ml vial 2700 4985 7685 9 17 26

Papaverine HCl 30mg/ml, in 2ml vial 1495 2908 4403 8 19 27

Esmolol HCl 10mg/ml, in 10 ml vial 1405 2958 4363 10 21 31

Milrinone lactate 10mg vial 2302 2057 4359 10 14 24

Dantrolene sodium 20mg/65mL vial 408 850 1258 11 20 31

Top Requested Drugs

Drug

Quantity requested per year Frequency of request

2013 2014 Total 2013 2014 Total

Sotalol 80mg tablet 10400 13030 23430 2 2 4

Propafenone 150mg tablet 4400 14500 18900 1 2 3

Liothyronine (Cynomel) 25mcg tablet 7220 7800 15020 4 4 8

Co-trimoxazole (Trimethoprim 16 mg/ml

+ Sulfamethoxazole 80 mg/ml) [Bactrim]

Solution for injection, in 5ml vial

1450 9112 10562 3 8 11

Fludrocortisone 0.1mg tablet 3100 5800 8900 2 4 6

Provocholine nebulization kit 1700 3400 5100 2 2 4

Provocholine 100mg/vial 288 475 763 2 2 4

Top Requested Drugs

Hospitals No. of applications per year

2013 2014 Total

St. Luke's Medical Center – Global City 6 12 18

St. Luke's Medical Center – Quezon City 8 8 16

Cardinal Santos Medical Center 8 7 15

The Medical City 5 7 12

Philippine General Hospital 7 3 10

Makati Medical Center 3 6 9

University of Santo Tomas Hospital 2 6 8

Asian Hospital and Medical Center 2 5 7

Manila Doctors Hospital 2 5 7

Philippine Heart Center 2 2 4

Top Requesting Hospitals



Issues for Discussion

• Misalignment with AO 4

• Concerns from Hospital Group

• List of Products

Issues for Discussion

• Regular request (from 2 to 12 times a year) for permit to import of unregistered to be used for critical care, strictly for their own use

• Quantity is considered to be substantial

• No specific patients identified

Misalignment with AO 4

• 13 April 2015 – representatives from PHA and PSHP

• Some of the concerns: – Hospitals acknowledge the risks – waiver – No choice – no MAH/importer is willing to

register due to “low volume” = not profitable – Some drugs are included in the PNDF but not

available in the market

Concerns from Hospital Group

List of Products Drug Company*

Phenylephrine 1% 10mg/1ml vial WEST WARD PHARM CORP; ECLAT PHARMS LLC;

Nitroprusside (Nitropress) 50mg/2ml vial HOSPIRA Dantrolene sodium (Revonto) 20mg/65mL vial

US WORLDMEDS PAR STERILE PRODUCTS

Dipyridamole (Persantin) 10mg/2ml ampoule

BEDFORD FRESENIUS KABI USA HIKMA MAPLE

Protamine sulfate 10mg/ml, in 5ml vial FRESENIUS KABI USA Thrombin 5000 units/5ml vial PapaverineHCl30mg/ml, in 2ml vial AMERICAN REGENT, INC. Vasopressin (Pitressin) 20 units/ml vial PAR STERILE PRODUCTS

Colistimethate sodium (Colomycin) 1 Million Unit vial

EMCURE PHARMS LTD; FRESENIUS KABI USA; PADDOCK LLC; AGENT PHARMS; X GEN PHARMS; PAR STERILE PRODUCTS


Milrinone lactate 10mg/10ml vial

BEDFORD; FRESENIUS KABI USA; GLAND PHARMA LTD HOSPIRA INC

Ferric subsulfate (Astringyn) topical solution Cooper Surgical

Adenosine (Adenocor) 6mg/2ml vial

AMDIPHARM MERCURY COMPANY LIMITED; FOCUS PHARMACEUTICALS LTD; WOCKHARDT UK LTD

EsmololHCl (Brevibloc) 10mg/ml, in 10 ml

vial

BAXTER HEALTHCARE;

EUROHLTH INTL SAR;

FRESENIUS KABI USA;

LUITPOLD;

MYLAN INSTITUTIONAL

Thiopental sodium 500mg

Powder for Injection Solution, in Vial

ARCHIMEDES PHARMA UK LTD

Ferric subsulfate (Monsel’s) 8 ml Solution Clique Hemostasis Products


Lidocaine HCl 2% Jelly USP, 30ml tube

SAGENT PHARMS;

AKORN;

INTL MEDICATION;

WATSON LABS INC;

OAK PHARMS

Streptokinase (Streptase) 1.5 Million units, vial BEACON PHARMACEUTICALS;

CSL BERHING UK LIMITED

Aminocaproic acid 250mg/ml, 20ml vial LUITPOLD;

HOSPIRA

Calcium chloride 100mg/ml, 10ml vial International Medication Systems (UK)

Cyclosporine (Sandimmune) 250mg/5ml

ampoule

Novartis Pharmaceuticals


Etomidate (Amidate) 2mg/ml, 10ml vial

HOSPIRA;

AGILA SPECLTS;

BEDFORD;

EMCURE PHARMS LTD;

LUITPOLD;

PAR STERILE PRODUCTS;

ZYDUS PHARMS USA INC

Labetalol HCl injection 100mg/20ml vial

AKORN INC;

EUROHLTH INTL SARL;

GLAND PHARMA LTD;

HOSPIRA

Metolazone 5mg tablet

UCB INC;

SANDOZ;

MYLAN

Pentafluoropropanetetrafluoroethane

(Gebauer'spain Ease) 3.5 Oz Medium Stream

Spray

GABAUER COMPANY


Estriol (Ovestin) Vaginal Cream 1mg/g, 15g

tube

ASPEN

Verapamil HCl 2.5mg/ml ampoule ABBOTT

HOSPIRA

Trientinedihydrochloride (Syprine) 300mg

capsule

ATON PHARMA, INC.

Isosorbidedinitrate (Isoket) 0.1% 1mg/ml

ampoule

UCB PHARMA LIMITED

Fludrocortisone 0.1mg tablet E.R. SQUIBB & SONS LIMITED

Sotalol 120mg tablet

COVIS PHARMA SARL;

UPSHER SMITH;

APOTEX;

EPIC PHARMA INC;

IMPAX PHARMS;

MYLAN;

SANDOZ;

TEVA;

VINTAGE


Sotalol 80mg tablet

COVIS PHARMA SARL;

UPSHER SMITH;

APOTEX INC;

EPIC PHARMA INC;

IMPAX PHARMS;

MYLAN;

SANDOZ;

TEVA;

VINTAGE

Diltiazem 5mg/ml, 10ml vial

AKORN INC;

BEDFORD;

HIKMA FARMACEUTICA;

HIKMA MAPLE;


Irinotecan 100mg/5ml vial

PFIZER INC;

ACCORD HLTHCARE;

ACTAVIS TOTOWA;

AKORN;

BEDFORD LABS;

CIPLA LTD;

DR REDDYS LABS LTD;

EBEWE PHARMA;

EMCURE PHARMS LTD;

FRESENIUS KABI ONCOL;

FRESENIUS KABI USA;

HIKMA FARMACEUTICA;

HISUN PHARM HANGZHOU;

HOSPIRA;

JIANGSU HENGRUI MED;

MUSTAFA NEVZAT ILAC;

PLIVA LACHEMA;

SUN PHARMA GLOBAL;

TEVA PHARMS USA


Pentamidine isethionate 300mg vial FRESENIUS KABI USA

Argatroban (Acova) 250mg/2.5ml Single-use

vial

PFIZER;

HIKMA PHARM CO LTD;

MYLAN INSTITUTIONAL;

PAR STERILE PRODUCTS;

FRESENIUS KABI USA

Melphalan 50mg vial ASPEN

Fludarabine (Fludara) 50mg vial SANOFI

Alprostadil (Caverject) 40mcg/ml vial

PFIZER, INC.

PHARMACIA AND UPJOHN;

AUXILIUM PHARMS LLC

Busulfan (Myleran) 2mg tablet ASPEN GLOBAL

Azacitidine 100mg vial DR REDDYS LABS LTD;

CELGENE


Naltrexone HCl 50mg tablet

ACCORD HLTHCARE;

BARR;

ELITE LABS;

TEVA WOMENS;

SUN PHARMA GLOBAL;

MALLINCKRODT

Chemet 100mg capsule RECORDATI RARE

Liothyronine (Cynomel) 25mcg tablet

KING PHARMS R AND D;

COASTAL PHARMS;

MYLAN;

SIGMAPHARM LABS LLC

Liothyronine 50mcg tablet

KING PHARMS R AND D;

COASTAL PHARMS;

MYLAN;

SIGMAPHARM LABS LLC


Carmustine (BCNU) 100mg vial EMCURE PHARMS LTD

Edrophonium 10mg/ml ampoule MYLAN INSTITUTIONAL

Hydroxyprogesteronecaproate (Proluton depot)

250mg/ml ampoule

LUMARA HEALTH INC

Bendamustine 100mg vial CEPHALON

Propafenone 150mg tablet

ANI PHARMS INC;

MUTUAL PHARM;;

VINTAGE PHARMS

GLAXOSMITHKLINE LLC

Propafenone 300mg tablet

ANI PHARMS INC;

MUTUAL PHARM

VINTAGE PHARMS;

GLAXOSMITHKLINE LLC

Quinidine sulfate 200mg tablet

MUTUAL PHARM;

ATSON LABS;

SANDOZ


Potassium acid phosphate 10mmol/10ml

ampoule

MARTINDALE

PHARMACEUTICALS LTD

Sodium tetra decylsulfate (Fibrovein) 3% 2ml

ampoule

STD PHARMACEUTICAL

PRODUCTS LT

Procainamide 100mg/ml, 10ml vial HOSPIRA

Alprostadil 500mcg/ml ampoule

PHARMACIA AND UPJOHN

TEVA PHARMS USA

EUROHLTH INTL SARL

Phentolaminemesylate 10mg/ml ampoule BEDFORD LABORATORIES

SAMARTH PHARMA PVT. LTD.

MidodrineHCl 10mg tablet

APOTEX INC

IMPAX PHARMS

MYLAN PHARMS IN

SANDOZ

UPSHER SMITH

Cinacalcet HCl (Mimpara) 30mg tablet AMGEN


Cinacalcet HCl (Mimpara) 60mg tablet AMGEN

Ora-Plus Oral Suspending Vehicle 473ml PADDOCK LABORATORIES

Potassium Iodide (Jodid) 100mcg tablet MERCK

Glycopyrrolate 0.2mg/ml, in 5 ml vial AMDIPHARM MERCURY

COMPANY LIMITED

Fluorescein Injection ALCON LABORATORIES UK

LIMITED

Glyceryl trinitrate 10mg/10ml ampoule

LUITPOLD; HAMELN PHARMA

PLUS GMBH; MERCURY PHARMA

INTERNATIONAL LTD

Rho(D) Immune Globulin Intravenous Human

1500 IU (300mcg) per 3ml, lyophilized

powder for injection, in vial

JOHNSON & JOHNSON

Isoproterenol (Isoprenaline) 0.2mg/ml, 1ml

ampoule

HOSPIRA


Co-trimoxazole (Trimethoprim 16 mg/ml +

Sulfamethoxazole 80 mg/ml) [Bactrim]

Solution for injection, in 5ml vial

INTERNATIONAL APEX

PHARMACEUTICALS, INC.

MUTUAL PHARM

Metolazone 2mg tablet SANDOZ

Dantrolene sodium 20mg tablet PAR STERILE PRODUCTS

NORGINE LIMITED

IMPAX LABS

MIKAH PHARMA

Provocholine 100mg/vial METHAPHARM INC.

Provocholine nebulization kit METHAPHARM INC.

• Foreign supplier has local counterpart, yet products are not registered due to “low demand”

List of Products

• Mandatory registration will be required for the products – MAH will have prioritized review – Pending applications of CSP may be granted one

last time

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