India's Pharmaceuticals industry is growing at a CAGR of 13.7 percent and is expected to cross $10 billion revenues by 2010. Manufacturers constantly strive to overcome business challenges related to improving productivity, inventory management, time to market, and global competition. However, the challenge of counterfeit drugs in the market is a challenge manufacturers would not want to face. Although this is a global phenomenon, for an emerging market such as India, the impact is far more pronounced. The Association of Commerce and Industry of India (Assocham) estimates in India believe that the fake and counterfeit drugs are growing at an alarming rate of 20-25 per cent annually. Efforts to combat the menace ought to seriously begin.
Newer technologies make it easy to imitate drug labeling and established pharmaceutical manufacturers find the going tough to counter this. Origin of counterfeit drugs, as per USFDA is mostly from Latin America and Asia with India identified as a significant source of such supplies. 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 of 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.
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 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 labeling, 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.
ARC believes that pharmaceutical companies have little option but to embrace technologies such as these to insure themselves against colossal revenue losses. 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 and domestic automation majors, such as ABB, Siemens, Rockwell Automation, Emerson, Omron, and L&T, 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.