Pharmaceutical Anti-Counterfeiting in Emerging Regions

It’s been a year or so  since that the 1st Pharmaceutical Anti-Counterfeiting in Emerging Regions”  that FDASmart organized and hosted in Mumbai, now we are back!

For those of you who missed it – here’s what happened last year March 4th – 2011 in Mumbai at the Lalit Hotel:  www.fdasmart.com/events/pharma-anticounterfeitinglalit.html

Back then,  DGFT created a scare in the industry for 2-D barcoding deadlines July 2011 which seems unrealistic  to achieve and indeed that July 2011 deadline  date has been postponed and strategically parsed out into stages for tertiary then secondary followed last by primary packaging (most challenging of all). One thing is sure that announcement served as a wake-up call !

The wake-up call is that counterfeits REMAIN a SERIOUS THREAT AND GETTING BIGGER while the industry and various stake-holders are mobilizing on their sides for a serious battle.
Come April 11th at the ITC Maratha Hotel, Mumbai – FDASmart will once again hosts a similar conference with its “2nd Pharmaceutical AntiCounterfeiting in Emerging Regions: Who’s Winning the Battle”?

The question that begs an answers in obvious, i.e. what’s happened since March 4th -2011?

 “A lot!” – is the short answer, some good  (wins for anti-counterfeiting) and   some not so good  (setbacks for the “good guys”!).

 

Here’s some of the good ‘stuff’: Pharma anticounterfeiting event

 

* DGFT extends barcoding  deadlines –for barcoding of Primary Level Packaging has now been extended to July 2012, Secondary Packaging to January 2012 and of course Tertiary Packaging as of October 2011,

( ** Per Deferment in the date of effect for implementation of bar-coding on export consignment of pharmaceuticals and drugs for tracing and tracking purpose, Per Govt of India regulations (Dept of Commerce & Industry, DGFT)  ** )

* The US FDA has called for more authority to ensure any track-and-trace system is binding for the industry as a whole and transcend state to state laws? California is slated to begin its e-Pedigree laws come 2015. Others states will follow, perhaps with their own laws.
If the US FDA is unable to pre-empt a nationwide standard , a patchwork of laws in the US will create a whole set of standards to adhere to thus ASSISTING counterfeiters instead of STOPPING THEM !

* Union health minister, Ghulam Nabi Azad, recently announced a “whistle blower policy”
At present, based on the information gathered by the Central Drugs Standard Control Organisation, the office of the Drug Controller General of India raids places suspected of manufacturing or selling such drugs The tip-off often comes from a member of the general public. The government hopes that a cash reward will lead to more people coming forward with such information.

The Indian Drug Manufacturers Association (IDMA) in Mumbai, which represents the interests of Indian (as opposed to foreign) drug manufacturers, is all praise for the whistle blower policy. “This policy is a timely one. The fact that it seeks to reward people for giving information on the manufacture and sale of spurious drugs is why the chances of it being successful are so high. If implemented properly, this policy will make it difficult for spurious drug makers to operate,” says Daara B. Patel, secretary-general of the IDMA.

* CoE (Council of Europe) launches an online system for Europe where patients can check the authenticity of their medications just using a SmartPhone, users from 36 member states of the European Pharmacopoeia are participating !

*
PharmExcil launches Patent Cell – so Indian pharma exporters can pre-empt generic un-warranted seizures
With the support of the Department of Pharmaceuticals, PharmExcil members are being made aware that they can avail use of the Patent Cell –i.e. off late several shipments of legitimate genuine exported consignments of generic medicines from India are being detained / seized by various European / US custom authorities alleging as counterfeit drugs / infringement of patents of innovators etc.

But the bad stuff, unfortunately—keep coming AS WELL ! Pharma anticounterfeiting event



* Spurious / fake medicines from China with “Made in India” labels in Nigeria
Recently Ministry of Commerce received notification from the  Director of NAFDAC (Africa) , stating  US$ 2.16 worth of  million anti-malarial drugs were seized by NAFDAC, on 21st May 2009.  It was found by the authorities that the products bear “Made in India” labels indicating that they were manufactured in India, but the bill of lading indicates that they are exported from China!

* Pfizer fumbles with packaging hurdles

* Avastin fake hits the US!
The FDA and Genentech , owned by Swiss drug manufacturer Roche, this week warned of the discovery of fraudulent vials of the blockbuster cancer drug Avastin. The allure for counterfeiters to make the jump to the U.S. is made clear in Avastin's financial numbers. A 400-mg vial of the med--the size that was counterfeited--costs $2,400!

* When you add in the desperation stemming from the short supplies of some lifesaving drugs in the U.S., the conditions for counterfeiting become ideal. Drug shortages prime the pump. Michael Cohen, president of the Institute for Safe Medication Practices, told The Financial Times the shortages have pressured hospitals to seek other ways to acquire drugs, thus raising the risk of counterfeits entering the market.

* Did you know that the US FDA currently requires that drugs sold into the US markets be identified with the NDC specifically with Linear Barcodes! That means that in the U.S. today, you cannot move away from linear barcodes on your drug product, even when you need to add serial numbers to them for compliance with  the  California Pedigree Law in 2015-2017.

.. and much, much More ! On April 11th at the ITC Maratha Hotel in Mumbai, India Come See Find out from your peers what’s New, what Worked and what Did not. Network with new contacts and Share or Discover new business leads, develop business relationships that could turn into new business development for your companies or careers.