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Indian Journal of Pharmacology, Vol. 39, No. 5, September-October, 2007, pp. 255 Correspondence Counterfeit and substandard drugs: The need for an effective and stringent regulatory control in India and other developing countries A. Sukhlecha Pharmacology Department, M P Shah Medical College, Jamnagar Correspondence Address:Pharmacology Department, M P Shah Medical College, Jamnagar Code Number: ph07065 I have read with interest 'Counterfeit and substandard quality of drugs: The need for an effective and stringent regulatory control in India and other developing countries'. [1] There are several technologies that may prove helpful in combating this problem. One such technique is radio-frequency identification (RFID) that uses electronic devices to track and identify items, such as pharmaceutical products, by assigning individual serial numbers to the containers holding each product. The FDA is working towards developing an electronic pedigree (E-Pedigree) system to track drugs from factory to pharmacy. This technology may prevent the diversion of drugs or counterfeiting by allowing wholesalers and pharmacists to determine the identity and dosage of individual products. [2] Another such product, the ICODE UID-OTP, features an NXP-programmed Unique Identifier (UID), guaranteeing the RFID tag. It is unique and has a one-time programmable memory that locks the user data after being programmed. The product also supports a destroy command, allowing the RFID tag to be permanently disabled when the customer picks up his or her prescription from the pharmacy, ensuring privacy. [3] A new technique, Raman spectroscopy, can be used to discover counterfeit drugs while they are still inside their packaging. [4] Scientists at the Centre for Disease Control and Prevention (CDC) have adapted a low-tech device to test and detect counterfeit drugs. They reported their results (on a method to test antimalarial drugs) at the 50 th annual meeting of the American Society of Tropical Medicine and Hygiene in Atlanta. The device, called a handheld Refractometer, has been used to measure the specific gravity of urine specimens. By measuring specific gravity of certain dissolved drugs , it was possible to determine the amount of the active ingredient in a tablet. The device could be used as a first line of defense against counterfeits. [5] In light of the increasing severity of the problem of counterfeit drugs, the World Health Organization has established a Rapid Alert System (RAS), the world′s first web-based system for tracking the activities of drug cheats. The Organization of Pharmaceutical Producers of India (OPPI) has recommended that the passage of the bill number LIV of May 2005 (to amend the Drugs and Cosmetics Act 2005), that seeks to enhance the punishment for counterfeiting of drugs and to make it a nonbailable offence, should be accelerated. [6] Acknowledgement I wish to thank the members of netrum@yahoogroups.com for their valuable inputs on this topic, which helped me in preparing this article.References
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