In a move that can help arrest the counterfeit drug market in the country, the Rs 650-crore pharma solution provider Bilcare Research is planning to commercially launch a low-cost anti-counterfeit packaging technology in the last quarter of this fiscal. The domestic counterfeit drug market has been pegged at Rs15,000 crore by Assocham and Rs 4,000 crore by CII and is said to be growing at 25% annually.
Bilcare?s technology would require a tag on the packaging material at a cost of around Rs 3, with a scanner priced at Rs 15,000 that will work to track the e-pedigree of the drug in question. The company estimates that volume sales could eventually drive down the cost of the product further – both tags and scanners? once the technology in real sense becomes a mass product. The tag aims at replacing the all-pervasive hologram culture.
Bilcare conducted a small study and found that consumers couldn?t differentiate between two drug packs with hologram and normal silver label. The company also claims holograms are anything but foolproof and there is a parallel hologram copying industry that has spawned around counterfeit drug industry.
Speaking about the real-time nano particulate-based fingerprinting, Praful Naik, Bilcare chief scientific officer (CSO), said, ?The technology is something like throwing a handful of sand at a screen. The chance of getting the same pattern twice is almost zero?.
The tag will be activated only after it reaches the pharma manufacturer?s plant and is applied on the production line.
The technology is currently being pilot tested by a few international pharma companies and some large domestic pharma companies that would, in most likelihood, integrate the system in their manufacturing facility by the end of third quarter of this fiscal, added Naik.
Each drug pack will have a unique fingerprint coded in a tag, which looks like an usual barcode. This fingerprint, once integrated cannot be replicated even by Bilcare itself, the company claims.
The information that would be coded along with fingerprint would include the pharma company?s manufacturing facility, date, and batch number. Whether a drug pack in the market is original or not, can be checked by the drugmaker or retailer or consumer by using a scanner that communicates the fingerprint details to a data server, which in turn sends a return signal to confirm the authenticity of the product.
The company claims that at whichever point (after activation), the tag is tampered with, the server would immediately catch it and the fingerprint once disintegrated cannot be reassembled, so the probability of the technology leaking out is virtually nil.
The global counterfeit drug business was estimated to be worth about $50 billion at the end of 2006.
Although there is no consensus, various estimates put the counterfeit drug industry ranging from 0.25% to 25% of the overall pharma industry size. Going by the government?s latest estimate, the size of the pharma industry is pegged at more than Rs 60,000 crore growing at a rate of 10 to 15% annually.
According to a World Health Organisation (WHO) update of 2007, one in five medications sold in India?s major cities is fake.
The pharma industry claims a minimum annual revenue loss of 5% due to fake drugs. Sales of counterfeit drugs worldwide are estimated at $50 billion, causing over $50 billion annual loss to the global pharmaceutical industry, according to recent estimates.
The WHO defines a counterfeit medicine as ?one which is deliberately and fraudulently mislabeled with respect to identity or source.
Counterfeiting can apply to both branded and generic products and counterfeit products may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient active ingredients or with fake packaging?.
In India, while the Mashelkar Committee has addressed the issue of spurious drugs and suggested curative steps, a current technical committee constituted by principal scientific advisor to prime minister is mulling over the preventive steps to curb the spurious drug menace.
Right dose
•Bilcare?s technology will require a tag on the packaging material at a cost of around Rs 3, with a scanner priced at Rs 15,000 that will work to track the e-pedigree of the drug in question
• Each drug pack will have a unique fingerprint coded in a tag, which looks like an usual barcode. This fingerprint, once integrated cannot be replicated even by Bilcare itself, the company claims
• According to WHO update of 2007, one in five medications sold in India?s major cities is fake. The pharma industry claims a minimum annual revenue loss of 5% due to fake drugs
• Sales of counterfeit drugs worldwide are estimated at $50 billion, causing over $50-billion annual loss to the global pharmaceutical industry
