Guest guest Posted June 29, 2008 Report Share Posted June 29, 2008 Dear Dr. Vijay Sir: Thanks a lot for your posts as well as your compliments. I agree with you that if at all pharmaceutical companies will come out with some concrete technology to counter counterfeiting of medicines, they will not do with for a patient's benefit but to minimize their own losses due to spurious medicines which runs into billions of rupees. These big houses make every move in light of their own profits. I also endorse your view that if medicines are priced appropriately and made affordable, graph of spurious drug production will automatically decline. But that seems to be a distant dream in view of the fact that draft of new drug policy that was prepared in December 2005 by the GOI is still hanging in air and has not been adopted so far due to govt.'s intentions of bringing essential medicines under price control. Now so far as RFID is concerned, I wish to state that there are currently multiple weaknesses in the use of Radio Frequency Identification (RFID) like cost, privacy concerns, complex logistics throughout the distribution chain and there is consensus that its full implementation is only foreseeable in a distant future. Consequently alternatives need to be sought for individual pack coding today so as to combat the menace of spurious medicines worldwide. Mobile technology has revolutionized the whole world. Billions of mobile connections are operating worldwide. In our country too, every second or third person is probably carrying a cell phone. Today we perform a host of our day to day transactions and activities through our mobile ranging from booking our tickets, making bill payments, knowing exam results, mustering public opinion on some grave issue concerning people at large and what not. Now the point to ponder is whether mobile technology can be made use of in verifying authenticity of medical products and thereby combating the menace of spurious medicines. One such proposal has been presented before WHO-IMPACT by VOXIVA YOTTAMARK on March 13, 2007 vide its “Phones for Health†Programme. This SMS based technology has already been utilized for US govt.’s global HIV/AIDS programme and also on global scale for Health program management, Patient monitoring, Disease surveillance, Drug supply chain management and Anti-counterfeiting measures.. This technology makes use of unique encrypted code on every medical unit that can be verified with SMS and a web machine-readable 2D code that can also be verified with a cell-phone camera or scanner. It also uses a Tamper-evident security seal that can include many other security layers. Using this technology authenticity and drug type can be verified by sending a simple sms to sms@... Alternately 24-digit code located on the medical product can be fed into a window on the company's website (URL given below) and authenticity can be checked. This solution has been used successfully on bottled water, electronic items, fresh food and ink cartridges. For further details, please view the PDF document attached herewith or log on to www.drugID.com. Comments of all members on this technology please.With regards 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: WHO-RFID:Measures to combat menace of spurious medicines Hi,I am aware of this proposition and its miniscule implementaion by few pharmaceutical companies for their high value products. It has been tried with the sole interest that the manufacturer does not loose the earning on its original product, if the spurious are selling. The production of spurious medicines is done because the indulger stands to mint great money through it. The returns are great because the original product has high mark up. If medicines are priced economically and are affordable to common population, production of spurious medicines will not be indulged.Vijay>> Dear Dr. Santosh:> I am highly thankful to you for your kind acknowledgement of my earlier post. In this post I am giving information about RFID-Radio frequency Identification Technology to track counterfeit drug products through the supply chain. I don't know how useful this technology to trace spurious medicines can prove in the context of our country. Can you give your comments on that.> Radiofrequency Identification Technology: > Protecting the Drug Supply> The FDA has stepped up its efforts to improve the safety and security of the nation's drug supply by encouraging use of a state-of-the-art technology that tags product packaging electronically. The technology, called radiofrequency identification, or RFID, allows manufacturers and distributors to more precisely track drug products through the supply chain.> RFID makes it easier to ensure that drugs are authentic, and it also creates an electronic pedigree--a record of the chain of custody from the point of manufacture to the point of dispensing. Electronic pedigrees will improve patient safety and protect the public health by allowing wholesalers and retailers to rapidly identify, quarantine, and report suspected counterfeit drugs and conduct efficient, targeted recalls. In November 2004, the FDA published a compliance policy guide for industry on implementing RFID studies and pilot programs. Acting FDA Commissioner Dr. Lester M. Crawford says the agency's actions were designed with one main goal: "to increase the safety of medications consumers receive by creating the capacity to track a drug from the manufacturer all the way to the pharmacy."> The FDA acknowledged the leadership of & in establishing standards for RFID technology and participating in RFID pilot studies. The agency also applauded initiatives announced by Pfizer, GlaxoKline, and Purdue Pharma. Pfizer announced its plans to place RFID tags on all bottles of Viagra (sildenafil) intended for sale in the United States in 2005. GlaxoKline has announced that it intends to begin using RFID tags on at least one product deemed susceptible to counterfeiting. Purdue Pharma announced that it is placing RFID tags on bottles of the pain reliever OxyContin (oxycodone) to make it easier to authenticate, as well as to track and trace the medication. OxyContin, which is a controlled substance, has been subject to abuse, theft, and diversion. Based on the availability of sufficient RFID tags, Purdue also plans to tag bottles of Palladone (hydromorphone) , a newly approved product to treat persistent moderate-to- severe pain.> The FDA considers electronic pedigrees to be a type of "electronic safety net," which allows illicit drug transactions to be rapidly identified and potentially transmitted to the FDA. This could improve the agency's ability to conduct investigations of suspected counterfeiting or the diversion of prescription drugs. The FDA believes its compliance guide will clear the way for more pilot programs that involve RFID tagging of all packages of certain products, especially those that are highly likely to be counterfeited. The FDA hopes that more firms will use RFID technology and gain experience with transferring, storing, and securing data that RFID provides.> The scope of the compliance guide is based on information the FDA obtained concerning RFID feasibility studies examining the use of this technology for various business purposes, including inventory control and tracking and tracing of drugs. To encourage these studies, the guide announces the FDA's intention to exercise enforcement discretion if certain studies trigger regulatory requirements. The FDA's actions are key steps in implementing a major recommendation of the agency's report, "Combating Counterfeit Drugs." That report recommended that RFID technology be in widespread use throughout the pharmaceutical industry by 2007.> > Kind regards> Zeenat Ashraf> From Chandigarh to Chennai - find friends all over India. Click here.. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted June 29, 2008 Report Share Posted June 29, 2008 Hi, I am enlighetened by the use of SMS technology in verification of original medicines. Let us hope some technique will be finally adopted for the welfare of the patients to check the spurious medicines. I have some dilemmas. Any system which is brought in will be sabotaged because: - If there are some self interested companies to tag the medicines, there are many others who want to manufacture spurious medicines - If the originality of medicines can be cross checked, the interest of those in supplly chain of spurious will be affected - If all medicines in the pharmacy can be tagged, purchase and sale of medicines will be affected, there by earning of the extra money through evaded duties and taxes will hurt the medicine business community - If the extra income of medicine business comes down, the grease to regulating authorities will be less Hence it is not easy to cleanse the system. But never the less effort is required and well begun- half done. Vijay > > > > Dear Dr. Santosh: > > I am highly thankful to you for your kind acknowledgement of my > earlier post. In this post I am giving information about RFID- Radio > frequency Identification Technology to track counterfeit drug > products through the supply chain.. I don't know how useful this > technology to trace spurious medicines can prove in the context of > our country. Can you give your comments on that. > > Radiofrequency Identification Technology: > > Protecting the Drug Supply > > The FDA has stepped up its efforts to improve the safety and > security of the nation's drug supply by encouraging use of a state- > of-the-art technology that tags product packaging electronically. > The technology, called radiofrequency identification, or RFID, > allows manufacturers and distributors to more precisely track drug > products through the supply chain. > > RFID makes it easier to ensure that drugs are authentic, and it > also creates an electronic pedigree--a record of the chain of > custody from the point of manufacture to the point of dispensing. > Electronic pedigrees will improve patient safety and protect the > public health by allowing wholesalers and retailers to rapidly > identify, quarantine, and report suspected counterfeit drugs and > conduct efficient, targeted recalls. In November 2004, the FDA > published a compliance policy guide for industry on implementing > RFID studies and pilot programs. Acting FDA Commissioner Dr. Lester > M. Crawford says the agency's actions were designed with one main > goal: " to increase the safety of medications consumers receive by > creating the capacity to track a drug from the manufacturer all the > way to the pharmacy. " > > The FDA acknowledged the leadership of & in > establishing standards for RFID technology and participating in RFID > pilot studies. The agency also applauded initiatives announced by > Pfizer, GlaxoKline, and Purdue Pharma. Pfizer announced its > plans to place RFID tags on all bottles of Viagra (sildenafil) > intended for sale in the United States in 2005. GlaxoKline has > announced that it intends to begin using RFID tags on at least one > product deemed susceptible to counterfeiting. Purdue Pharma > announced that it is placing RFID tags on bottles of the pain > reliever OxyContin (oxycodone) to make it easier to authenticate, as > well as to track and trace the medication. OxyContin, which is a > controlled substance, has been subject to abuse, theft, and > diversion. Based on the availability of sufficient RFID tags, Purdue > also plans to tag bottles of Palladone (hydromorphone) , a newly > approved product to treat persistent moderate-to- severe pain. > > The FDA considers electronic pedigrees to be a type of " electronic > safety net, " which allows illicit drug transactions to be rapidly > identified and potentially transmitted to the FDA. This could > improve the agency's ability to conduct investigations of suspected > counterfeiting or the diversion of prescription drugs. The FDA > believes its compliance guide will clear the way for more pilot > programs that involve RFID tagging of all packages of certain > products, especially those that are highly likely to be > counterfeited. The FDA hopes that more firms will use RFID > technology and gain experience with transferring, storing, and > securing data that RFID provides. > > The scope of the compliance guide is based on information the FDA > obtained concerning RFID feasibility studies examining the use of > this technology for various business purposes, including inventory > control and tracking and tracing of drugs. To encourage these > studies, the guide announces the FDA's intention to exercise > enforcement discretion if certain studies trigger regulatory > requirements. The FDA's actions are key steps in implementing a > major recommendation of the agency's report, " Combating Counterfeit > Drugs. " That report recommended that RFID technology be in > widespread use throughout the pharmaceutical industry by 2007. > >  > > Kind regards > > Zeenat Ashraf > > > > > > > Did you know? You can CHAT without downloading messenger. Go to http://in.messenger./webmessengerpromo.php/ > Quote Link to comment Share on other sites More sharing options...
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