ASPA draws anti-counterfeiting strategies for pharmaceuticals

Mumbai,  Feb 2016: Taking serious note of counterfeiting challenges faced by the pharmaceutical industry in the country, Nityanand S Sinai, Governing body member of Authentication Solution Providers' Association (ASPA) has stressed on four-point strategies which pharmaceuticals need to adopt to succeed in fighting this menace.
Technological solutions are available but pharmaceuticals need to have proper background work, CEO-led organisational commitment, right & scientific solution selection, planned solution implementation to ensure success in curbing counterfeit drugs, said Sinai who is also Managing director of PRS-Permacel Private Limited.
The background work will help pharmaceuticals to identify what kind of brand attack are they facing, why are they facing this brand attack. The types of brand attack include tampering the product or packaging or both with intention to steal, replace, modify, adulterate; replicate the product or packaging or both with the intention of fooling the customer he is buying the original; pass offs/look alike; duplication; counterfeit; diversion of the product form the market it is supposed to be sold to other markets; recirculation of the original packaging material and filled with substandard products, he added.
High price differential, non-availability of genuine product, no means available to the end user to distinguish at point of purchase, different buyer and end user, different physical flow of goods and communication flow, differential pricing policies followed for different markets are some of factors making a particular brand vulnerable to counterfeits, he said.
The background work will give pharma units a clear problem definition, areas where to focus and help them select a right solution, right technology or supplier and succeed in fighting this problem, Sinai said.
Talking about organisational commitment to tackle spurious drug menace, he said "A committed CEO/organisation, with belief that it is my problem and not bogged down by price control/past failures is most likely to succeed."
The pharmaceuticals can adopt solution according to their needs. There are a lot of technological solutions--level 1- overt features which highlight authenticity of the product; level 2 - covert-overt features which confirm authenticity by consumer involvement features; level 3 - full covert- need special devices for authentication; forensic features which punish counterfeiters in court of law- DNA verification, he said.
For technology to work, it must be understood that more the levers, higher the price. Single technology solutions can be copied easily. Selection of technology that fits into ones current manufacturing process is more likely to succeed. Where technology can be used it cannot be the only deterrent, it must a part of a fully integrated solution. Technology is not permanent. There is need to upgrade, he added.
In a bid to ensure success of technology solution in tackling counterfeit, a pharmaceutical needs to select a vendor willing to sign NDA, follow written ethical policy. The vendor should have experience & technology strengths and be ASPA member and not a trader (audit of facility is a must), he informed.
Talking about solution implementation, he said the implementation should be properly planned and should include reviews, next action plan, cost effectiveness and provision of upgradation. There should be coordination between CEO, marketing team, distribution team and legal team in this regard.
Source: Drugscontrol.org