Policies and Guidelines on the Campaign against the Sale and Use of Counterfeit VERORAB Rabies Vaccines

February 21, 2019

DILG MEMORANDUM CIRCULAR NO. 2019-025

POLICIES AND GUIDELINES ON THE CAMPAIGN AGAINST THE SALE AND USE OF COUNTERFEIT VERORAB RABIES VACCINES

1.0 Background

1.1 A Medical Product Alert released by the World Health Organization (WHO), confirmed the circulation of falsified Verorab rabies vaccines in the country. The genuine Verorab vaccine, manufactured by Sanofi Pasteur, is used to protect those who are at risk of exposure to rabies (pre-exposure vaccination) and prevent the development of rabies after exposure to animal bite of an animal suspected to having rabies (post exposure prophylaxis). HTcADC

1.2 The said alert provided product specification details of vaccines found to be falsified, which Sanofi Pasteur firmly denied manufacturing.

1.3 On December 27, 2018, the Department of Health-Food and Drug Administration (DOH-FDA), principally mandated to enforce Republic Act No. 8203 (An Act Prohibiting Counterfeit Drugs, Providing Penalties for Violations and Appropriating Funds Therefor), and its Implementing Rules and Regulations, issued Advisory No. 2018-334 dated December 27, 2018, warning the public on the purchase and use of said counterfeit vaccine product.

1.4 Section 16 of Republic Act (RA) No. 7160, otherwise known as the Local Government Code of 1991, provides that Local Government Units (LGUs) exercise the powers expressly granted to them for efficient and effective governance, and those which are essential to the promotion of the general welfare. Hence, Local Chief Executives shall ensure that these counterfeit vaccines are not allowed or sold in their respective areas of jurisdiction.

2.0 Purpose

2.1 In support of the above-mentioned DOH-FDA Advisory and WHO Medical Product Alert, this Circular will enjoin all Local Government Units (LGUs) to intensify information, education and communication campaign on banning the sale and use of the counterfeit Verorab rabies vaccines. CAIHTE

3.0 Scope/Coverage

3.1 All Provincial Governors, City Mayors, Municipal Mayors, DILG Regional Directors, ARMM Regional Governor and All Others Concerned.

4.0 Policy Content and Guidelines

4.1 To ensure public awareness campaign against counterfeit vaccines, all LGUs are encouraged to undertake the following:

4.1.1 Develop and disseminate Information, Education, and Communication (IEC) materials such as, but not limited to, tarpaulins, leaflets, brochures, audio-visuals and similar materials;

4.1.2 Promote public awareness by highlighting the difference between genuine and falsified vaccines, as specified in DOH-FDA Advisory No. 2018-334, on streamers hanged in front of health facilities, Animal Bite Treatment Centers (ABTCs), Animal Bite Centers (ABCs). The use of local radio networks, Facebook and Twitter accounts may also be encouraged;

4.1.3 Ensure that Hospitals, Veterinary Clinics, Health Centers, Animal Bite Treatment Centers (ABTCs), Animal Bite Centers (ABCs), and Local Veterinarians administering rabies vaccination shall only use genuine vaccines; aScITE

4.1.4 Adopt stringent regulatory procedure and requirements in the issuance of business permits to manufacturing companies and distribution centers, medical agents, pharmaceuticals, and other related business establishments; and

4.1.5 Coordinate with DOH-FDA thru email address: [email protected] and www.fda.gov.ph or Telephone No. (02) 809-5596, on suspected production, distribution and sale of counterfeit rabies vaccines in your locality, for proper investigation, filing and disposition of cases, as may be appropriate, pursuant to RA 8203 and other existing laws, rules and regulations.

4.2 All DILG Regional Directors and ARMM Regional Governor are hereby directed to cause the widest and immediate dissemination of this issuance to all local government units within their respective areas of jurisdiction.

5.0 Effectivity

5.1. This Memorandum Circular shall take effect immediately. DETACa

6.0 References

6.1 Republic Act No. 8203 (enacted on August 27, 1996)

6.2 Republic Act No. 7160 (The Local Government Code of 1991)

6.3 DOH-FDA Advisory No. 2018-334 dated December 27, 2018

7.0 Approving Authority

(SGD.) EDUARDO M. AÑOSecretary

ATTACHMENT

December 27, 2018

FDA ADVISORY NO. 334-18

 

The Food and Drug Administration (FDA) advises the public against the purchase and use of the verified counterfeit drug product Verorab rabies vaccine.

Figure 1. Box label of verified counterfeit Verorab Rabies Vaccine

Figure 2. Verified counterfeit sample vials and ampoules

The FDA, together with the Marketing Authorization Holder (MAH), Sanofi Pausteur Inc., have verified that the above mentioned in Figure 1 and 2 sample drug product is counterfeit.

Figures 3 and 4 show the registered drug product Verorab Rabies Vaccine.

The principal display panel of the label of Verorab Rabies Vaccine for Human Use Prepared on Cell Culture (Inactivated) 2.5 IU/0.5 mL Powder for Suspension I.D./I.M. Injection bears the following:

1. FDA-licensed Philippine importer and distributor

2. FDA registration number (BR-514)

3. Rx symbol

4. FDA caution statement on dispensing

5. Barcode

Figure 3. Box Label of Authentic Verorab Rabies Vaccine bearing the correct registration

Figure 4. Registered Drug Product vials and ampoules of Verorab Rabies Vaccine

All healthcare professionals, local health centers, health institutions and the general public are hereby warned as to the availability of this counterfeit drug product in the market which pose potential danger or injury to consumers. Consumers are also reminded to purchase drug products only from FDA-licensed establishments.

Likewise, all establishments and outlets are hereby warned against selling and/or dispensing this verified counterfeit drug product with the foregoing features. The importation, selling or offering for sale of such is in direct violation of Republic Act No. 9711, or the Food and Drug Administration Act of 2009, and Republic Act No. 8203, or the Special Law on Counterfeit Drugs, therefore a penalty shall be imposed.

All Local Government Units (LGUs) and Law Enforcement Agencies (LEAs) are requested to ensure that this counterfeit product is not sold or made available in their localities or areas of jurisdiction.

For more information and inquiries, please e-mail us at [email protected]. To report continuous sale or distribution of unregistered health products, kindly e-mail us via [email protected], or through the online reporting facility, eReport, at www.fda.gov.ph/ereport. You may also call the Center for Drug Regulation and Research at telephone number (02) 809-5596. For any suspected adverse drug reaction (ADR), report immediately to FDA through this link: www.fda.gov.ph/adr-report-new and fill out all the required fields.

Dissemination of the information to all concerned is requested.

(SGD.) NELA CHARADE G. PUNO, RPhDirector General