India's pharmaceuticals industry is growing at a CAGR of 13.7 per cent and is expected to cross $10 billion revenues by 2010. Manufacturers constantly strive to overcome business challenges on improving productivity, inventory management, time to market, and global competition. However, the menace of counterfeit drugs in the market is a challenge manufacturers would not like to face. Although this is a global phenomenon, for an emerging market such as India, the impact is far more pronounced. The World Health Organization estimated about a third of all the drugs sold to developing nations are fake and last year a report issued by the United Nations Office on Drugs and Crime predicted the global trade in fake pharmaceuticals has hit $75 billion by the 2008-09’ - an increase of 90 per cent since 2005.
The Association of Commerce and Industry of India (Assocham) estimates that the lethal market is growing at 25 per cent annually. It estimates that the fake and counterfeit drugs are growing at an alarming rate of 20-25 per cent in India annually. In fact, the Organisation for Economic Cooperation and Development's latest figures say 75 per cent of fake drugs supplied the world over have their origins in India. Efforts to combat the menace ought to seriously begin.
The US Food and Drug Administration (USFDA) and other drug regulators are pushing for the adoption of RFID hardware and software throughout the pharmaceutical industry to combat sales of counterfeit drugs. Food and Drug Administration Amendments Act (FDAAA) of 2007 requires FDA to adopt, by March 2010, standards for a standard numerical identifier for prescription medications at either the manufacturer or the pallet level.
In a March 2008 Federal Register notice, FDA described the purpose of the identifier as a way "to facilitate the identification, validation, authentication, and tracking and tracing of the prescription drug." Also as per USFDA origin of counterfeit drugs, is mostly from Latin America and Asia with India identified as a significant source of such supplies. FDA has since then stepped up its regulatory activities in India, including the opening of the agency's first office the country. And with Congress taking interest in securing the drug supply chain, it is expected some legislative action soon that may include drug pedigree and other track-and-trace requirements, possibly going all the way back to the ingredient level.
The fledgling pharmaceutical industry in India cannot afford to gets its reputation tarnished particularly when it boasts of the largest number of FDA approvals outside the US. Pharmaceutical Supply Chain with RFID and Public-key infrastructure (PKI) technologies employed has become the rallying point for overcoming this challenge in India. Newer technologies like these make it easy to imitate drug labelling and established pharmaceutical manufacturers find the going tough to counter this.
RFID and PKI technologies ensure to prevent proliferation of spurious drugs and this is how the technology broadly works. Authentication at both the manufacturing source and at the dispensing end together with PKI technologies renders the genuine product proof against counterfeit efforts. This approach based on real-time application is generally not dependant on any requirement of a host-network connection. Along the supply chain and at each stage, PKI provides the appropriate verification and validation.
An RFID transponder which is IEC (International Electrotechnical Commission) or equivalent standard based is integral to a silicon chip that provides a UID (Unique Identification Number), a code which is highly secure and that which cannot be easily altered. Along the supply chain such as labelling, packaging, and boxing a digital signature gets appended to the memory of the chip. On the distribution and dispensing end of the supply chain, signature is read through a "key". Technology apart, association of best practices is considered equally significant to render the whole process viable.
The author believes that pharmaceutical companies have little option but to embrace technologies such as these to insure themselves against colossal revenue losses. Global drug manufacturers that have tested RFID track-and-trace technology include Purdue Pharma, Pfizer and many more.
Deploying RFID and PKI technologies as an extension of inventory and WIP management will gain as much importance as electronic tracking and tracing that are oriented towards regulatory dictates. Global automation and IT majors, are among those who are able to provide such solutions. The question is no longer whether technology will impact business of pharmaceuticals, but how the industry will want to adopt technology to derive and maximize business.
The author is marketin manager of Tectura India