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Anti-Counterfeiting 2011
On March 4th, 2011 – FDASmart Inc (NY,USA) will host a one-day forum on “Pharmaceutical Anti-Counterfeiting in Emerging Regions: Who’s Winning the Battle”.
The World Health Organization (WHO) estimates that counterfeit drugs make up about 25%   of the global medicine market  in developing countries.  The US based Center for Medicines in the Public Interest (CMPI) projects that by 2010, $ 75 billion US dollars worth of counterfeit drugs will be sold annually.

This unique one-day forum  brings together international and local Indian stakeholders from the pharmaceutical industry, government and leading pharma associations in India to
address the number one problem : the war against drug counterfeits !

On March 4th in Mumbai, we will present the latest developments on the rapidly growing ,global drug counterfeiting scenario in emerging regions, discuss   the root causes that drive counterfeiting in underdeveloped  regions, then present  a thesis that a multi-level &  multi-stakeholder,  simultaneous joint effort  is mandatory in order to successfully combat  anti-counterfeiting .

Recently, the Foreign Trade Ministry of India made an announcement: that  Exporter of Pharmaceutical products will build track and trace capability for their exported medicines using barcode technology with  GS 1 global standards  by July 2011 to protect and ensure that India’s global generic industry continue with its reputation as the “pharmacy to the world”.

Several things come to mind:
- A realistic target date?  California has extended its e-pedigree deadlines to 2015  for a reason. Find out why.

-Does India have the serialization, authentication technologies to make this happen or do we partner with global technology providers to achieve this goal ?

Joseph Ringwood - COO- Systech International (NJ, US) and one of our key guest speakers  had this to say regarding the Foreign Trade Ministry Serialization announcement:
“We serve the global serialization market. This emerging regulation from India is different than that being implemented in Turkey and actually resembles California legislation.  A key point to be made is that the track and trace requirements do not specify infrastructure or the need to capture data and maintain it in any type of database for queries. This type of serialization is useless unless the product can at the very least be authenticated.”
-Who will police that Indian drug exporters observe this mandate and abide with the legal requirements?
COME attend the Anti-Counterfeiting Forum on March 4th and discover answers to these strategic questions and more !
Speakers from the US and India  will discuss  multiple level  of  anti-counterfeiting initiatives  that start  from packaging  level all way to consumers (PoD -Point of Distribution)

 One of our US experts will be discussing efforts in the African continent (Nigeria) by  the  national regulatory agency NAFDAC (National Agency for Food & Drug Administration & Control ) including a consumer driven, innovative first of a kind mobile phone authentication system.

The one-day  forum will feature several case studies on successful implementation of state of the art authentication, serialization and other technologies in the war against counterfeiting.

Roger Bate, from the American Enterprise Institute (AEI), says  “a lack of coordinated and dedicated effort is hindering anti-counterfeiting efforts. “

On a basic level, the lack of a universally accepted definition of what a counterfeit is underpins many problems.  Fundamentally, any fake drug  is illegal but lately Big Pharma seems to be equating “FAKE Drugs” synonymous to violating IPP – Intellectual Property Protection.  The recent detention of Indian generics in European ports, coupled to the drafting of legislation in Kenya and Uganda, has given countries reason to believe Western anti-counterfeiting efforts are at least partly motivated by desire to strengthen IPP.

Result? Emerging regions that are increasingly relevant to the global pharmaceutical industry like China and India take on a DEFENSIVE position, starting a  blame game that involved WHO (World Health Organization) and stifling international cooperation among ALL stake-holders.
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