Expressing concern over the growing threat posed by counterfeit drugs in India and abroad, the Pharmaceutical Security Institute (PSI), a not-for-profit corporation based in Washington engaged in protecting patient safety, sharing information on the counterfeiting of pharmaceuticals, initiating enforcement actions through the appropriate authorities, has stressed that pharma industries and law enforcement agencies need to jointly take proactive steps to check the spurious drug menace.
There are three areas where pharma industries can support the law enforcement agencies to curb counterfeit drug menace. These included risk management (intelligence and risk profiling), enforcement actions (product identification, investigative assistance) and capacity building (tailor-made training and awareness), said Samson Chiu, director, PSI (Asia Pacific region).
Active cooperation between pharma industry and regulatory authorities has become a key factor in tackling counterfeit drug menace. On the other hand, efforts need to be made to enhance capacity of law enforcement agencies to rein in fake drug trade.
Chiu, citing the reasons for failure of most enforcement actions, said, “Insufficient training, lack of determination, ineffective intelligence exchange, lack of cross-agencies cooperation, lack of international cooperation, and lack of trust and partnership with private sectors are some of the factors responsible for failure of most enforcement actions.”
The counterfeit drug is now a global phenomenon and almost all countries of the world are affected. A total of 1,689 counterfeit drug cases were reported in 2015 followed by 1,480 cases in 2014 and 1,729 cases in 2013. Over the last three years, there has been phenomenal rise in number of diversion cases. 1,104 pharmaceutical product diversion cases were reported in 2015 followed by 634 cases in 2014 and 406 cases in 2013. India ranked second in diverted products source and third in counterfeit products origin in 2015.
Considering the alarming counterfeit drug problem in the world, effective intelligence exchange, cross-agencies cooperation and international cooperation, drug regulatory body's training, industry participation are prerequisites to deal with the problem, he said.
Talking about international efforts to check counterfeit drug trade, he added, “PSI and Interpol have seized US$ 53 million fake and illicit medicines and suspended 4,932 websites in Operation Pangea IX launched with support of 103 countries in 2015. More than 2 tons of falsified and illicit drugs were seized during Storm VI operation held by PSI in collaboration with countries like India, China, Malaysia, Thailand, Laos, Mymmar, Philippines, Singapore, Pakistan, Vietnam, Cambodia etc. 45 cases of counterfeit erectile dysfunction drugs were resolved in Customs IPR operations in Asia Pacific in 2015 jointly conducted by 25 customs agencies of Asia Pacific region.
With representational offices in Washington, Hong Kong and London, the 33-member PSI network consisting of Takeda, Otsuka, Roche, Novo Nordisk, Chugai, Genentech, Novartis, Astellas, Gilead, Johnson and Johnson, AstraZeneca, Eisai, Pfizer, MSD, GSK, Merck, Sanofi, Amgen, Mylan, Bristol- Myers Squibb, Abbvie, Boehringer Ingelheim, Purdue, Abbott Laboratories, Lilly etc work closely with law enforcement agencies and drug regulators to investigate cases and to support prosecutors.
The PSI has Counterfeiting Incident System (CIS) which is used to record incidents of counterfeiting, theft and illegal diversion of pharmaceutical products worldwide. CIS incidents come from a variety of sources, including open media reports, PSI member company submissions, and public-private sector partnerships.