WHO-IMPACT - Measures to combat spurious medicines

[Guest guest]

Dear Zeenat:

We have last two days remaining for this discussion. There is a lot more to discuss. Thanks for giving it a desirable direction by citing WHO recommendations for combating the menace. At this occasion I wish to say something about IMPACT - International Medical Products Anti-Counterfeiting Taskforce. Responding to the growing public health crisis of counterfeit drugs, the World Health Organization launched the International Medical Products Anti-Counterfeiting Taskforce (IMPACT). The taskforce, created in 2006, has been active in forging international collaboration to seek global solutions to this global challenge and in raising awareness of the dangers of counterfeit medical products. IMPACT is comprised of all 193 WHO Member States on a voluntary basis and includes international

organizations, enforcement agencies, national drug regulatory authorities, customs and police organizations, non-governmental organizations, associations representing pharmaceutical manufacturers and wholesalers, health professionals and patients’ groups. These groups have joined to improve coordination and harmonization across and between countries so that eventually the production, trading and selling of fake medicines will cease. Here is more about IMPACT:

IMPACT activities

International collaboration and preventionCombating counterfeit drugs requires the participation of the public and all the stakeholders. Trade in counterfeit medicines is widespread and affects both developed and developing countries but is more prevalent in countries facing a variety of problems such as:

weak drug regulatory control and enforcement; scarcity and/or erratic supply of basic medicines; unregulated markets and distribution chains; high drug prices and/or significant price differentials.

At national level, governments, law enforcement agencies, heath professionals, the pharmaceutical industry, importers, distributors, and consumer organizations should adopt a shared responsibility in the fight against counterfeit drugs. ation between countries, especially trading partners is very useful for combating counterfeiting. ation should include the timely and appropriate exchange of information and the harmonization of measures to prevent the spread of counterfeit medicines.

Guidelines

The World Health Organization has developed and published guidelines, Guidelines for the development of measures to combat counterfeit medicines. These guidelines provide advice on measures that should be taken by the various stakeholders and interested parties to combat counterfeiting of medicines. Governments and all stakeholders are encouraged to adapt or adopt these guidelines in their fight against counterfeiting of medicines.

:: Guidelines for the development of measures to combat counterfeit medicines :: Rapid Alert System for counterfeit medicines

Communication and advocacy - creating public awareness

Patients and consumers are the primary victims of counterfeit medicines. In order to protect them from the harmful effects of counterfeit medicines it is necessary to provide them with appropriate information and education on the consequences of counterfeit medicines.

Patients and consumers expect to get advice from national authorities, health-care providers, health professionals and others from where they should buy or get their medicines; what measures they should take in case they come across such medicines or are affected by the use of such medicines.

Ministries of health, national medicines regulators, health professional associations, nongovernmental organizations and other stakeholders have the responsibility to participate in campaign activities targeting patients and consumers to promote awareness of the problem of counterfeit medicines. Posters, brochures, radio and television programmes are useful means for disseminating messages and advice.

Dr. Geer M. Ishaq

Sr. Lecturer

Dept. of Pharmaceutical Sciences

University of Kashmir

Srinagar-190006 (J & K)

Ph: 9419970971, 9906673100

E-mail: ishaq@...

Website: http://ishaqgeer.googlepages.com

Re:Measures to eradicate menace of spurious medicines

Dear Sir:

Given below are various WHO recommendations for eliminating courterfeiting menace and short-term and long-term anti-counterfeiting measures of USFDA.

Various recommendations incorporated in the WHO report:

1. Drug laws should be sufficiently comprehensive, covering all activities involving drug products and information and updated regularly;

2. One central agency should be accountable for the overall effectiveness of drug regulation;

3. Personnel engaged in drug regulation should have integrity and be appropriately trained and qualified. Staff should have access to the latest scientific and technological information to facilitate their work;

4. Sustainable financing is essential to promote effective drug regulation;

5. Appropriate standards and guidelines should be developed and used as tools for the application of regulatory processes;

6. The regulatory process should be systematically monitored in order to identify problems and determine whether actual activities match the intended actions;

7. Drug regulatory agencies should communicate regularly with their clients. They should also acknowledge the right of citizens to be provided with accurate and appropriate information on drugs marketed in their county.

SHORT TERM AND LONG TERM ANTI-COUNTERFEITING STRATEGIES OF USFDA

AVAILABLE NOW

AVAILABLE NEXT YEAR AND BEYOND

AVAILABLE WITHIN NEXT 3 YEARS AND BEYOND

Authentication Measures: Overt Measures Covert Measures Forensic Measures

Higher criminal penalties

Use of electronic pedigree

Unit of Use packaging

Education of Health Professionals and Consumers

Adoption of Model Rules for State Licensure of Wholesale Distributors in all states

Tamper evident packaging

Adoption of Model Rules for State Licensure of Wholesale Distributors in some states

Widespread international collaboration

Secure business practices

FDA Guidance on application and Notification Procedures for changes in products, packages and labelling for authentic drugs

List of drugs most likely to be counterfeited

Increased inspection frequency of repackagers by FDA

Counterfeit Alert Network

Increased international collaboration

Model Rules for State Licensure of Wholesale Distributors

Streamlined FDA rapid response to counterfeit reports

Kind regards

Zeenat Ashraf

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