8 Questions With : Javin Bhinde, MD and CEO of SynCore Consulting
Updated on: 29 Jun 2016
Javin Bhinde, MD & CEO, SynCore Consulting shares details of the PatientSafe India conference this year and its objectives. He also elaborates on the steps to deal with the challenge of counterfeit medicines, with Express Pharma
What is the extent of the counterfeit challenge in the pharmaceutical sector globally and in India?
Drug counterfeiting has emerged as a challenge not only in India but also globally, however it is considerably difficult to define the extent to which it has penetrated the pharma markets across the world. This is because there are many estimates of the scope and scale of the market in counterfeit medical products but little validated evidence to underpin those estimates. WHO has withdrawn all of their previous estimations of the scale of the problem and in 2013 launched a global surveillance system to report counterfeit incidents, to assist in arriving at a more accurate and validated assessment of the scope, scale and harm. In 2009, CDSCO found 11 out of the 24136 (0.046 per cent) samples collected from various retail pharmacies as spurious and three out of 2976 samples (0.1 per cent) as substandard (not conform to claim with respect to Assay on chemical analysis). As per WHO reports 50 per cent of illicit online pharmacies are selling counterfeit medications throughout the world. INTERPOL is running operations such as Operation Storm (Southeast Asia) and Operations Giboia, Mpili and Porcupine (all regions of Africa, for example). Between 2010 and 2014, these operations have led to the arrests of 1,400 suspects, the suspension of 57,000 illicit online pharmacies and the seizures of 500 tonnes and 30.3 million units of illicit medicines. Although many of the reports are extrapolations of sampling data and are often contested by other experts, one fact that none of them deny is the seriousness of the problem and the burning need to address it.
What are the measures being taken by regulators, both globally and in India, to combat the counterfeit challenge in the pharma sector?
Many countries especially in Africa have deployed SMS-based verification on authenticity. These have been shown to be quite effective in their application. International Medical Products Anti-Counterfeiting Taskforce (IMPACT) has been formed by WHO to tackle the issue. IMPACT has done a lot of work in securing worldwide cooperation across all stakeholders which many believe is the key to a successful long term resolution of the problem. Interpol has Project Pangea to tackle online counterfeit retail and Project Storm for anti-counterfeit in South-east Asia which is particularly sensitive to the issue. Track and trace technologies have been deployed by many European bodies in many different forms and have also been shown to be successful in identification and rapid response to incidences of attempted entry of counterfeit drugs into mainstream channels. Serialisation is also gaining momentum among many manufacturers and regulators as a robust measure against drug counterfeiting.
What measures have pharma companies taken to safeguard their products and supply chain?