Almost all major manufacturers of pharma products in India have acknowledged and responded to the counterfeit challenge in India

Javin Bhinde, Managing and Chief Executive Officer, 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 WHO has withdrawn all of their previous estimations of the scale of the problem and in 2013 launched a global surveillance system to report counterfeit incidents, to assist in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?

Pharma companies have taken a serious stance towards counterfeit drugs in all markets. The counterfeiting challenge is being addressed by a multi-pronged strategy centred on the following three pillars:

Availability: The availability of genuine drugs easily and reliably is likely to go a long way in prevention of the counterfeiting menace, especially in developing markets where the penetration of medicines may be limited

Awareness: The problem of drug counterfeiting is usually one that goes unnoticed when committed. The patient who consumes drugs with the wrong composition, spurious ingredients, and expired drugs or in some cases no active ingredients at all may be assumed to have suffered a deterioration in health due to some medical reason or due to a wrong diagnosis. Awareness of the counterfeiting problem, especially in geographies susceptible to the problem is a prime factor in initiating the process of its elimination.

Action: The regulations which are in effect need to have stricter punitive clauses as well as tighter enforcement by policing authorities to rein in the burgeoning number of counterfeiters. As it stands today, the regulatory and enforcement intensity leaves a lot to be desired.

Which pharma companies in India have responded to the counterfeit challenge in the pharma sector?

Almost all major manufacturers of pharma products in India have acknowledged and responded to the counterfeit challenge in the India. This is abundantly clear by the formation of a role of a ‘Chief Security Officer’ who is primarily tasked with detection and prevention of drug counterfeiting. This kind of a role was hitherto unknown in the business before the emergence of drug counterfeiting as a legitimate threat. The creation of a drug supply chain that is flexible enough to respond quickly to the actions of counterfeiters while simultaneously being lean enough to minimise the effort of policing along with reducing the potential points of leakage to a minimum is widely accepted a necessary condition to tackling drug counterfeiting. Such a superior supply chain design coupled with technological breakthroughs in anti-counterfeiting measures has led the way forward for most companies. Technology is currently being deployed to tackle the following key aspects of the process:

• Track and Trace
• Detection
• Packaging
• Online trade

Also, manufacturers are increasingly developing collaborative measures together with law enforcement agencies for rapid detection and response.

Have anti-counterfeiting measures resulted in increased costs at the manufacturing, quality and supply chain levels?

Many of the technologies that are potentially being developed and evaluated are currently likely to impose an economic penalty on the value of the medicine, which puts a strain on the resource strained economies. But, significant ground is being made in making these technologies scalable, easily adaptable and economically viable. A significant challenge in the past, widespread adoption of information technology, rapid reduction in prices of devices (like RFID, mobile phones etc) in some cases has reduced the cost of deployment by a factor of 10. But the deployment of barriers to counterfeiting does represent an economic cost burden that manufacturers and governments alike have acknowledged as an investment to protect the citizens and the overall interests of the practice of medicine. Whatever the cost, it is in the patients interest in the short and long run to focus on and address the issue at this point.

What are the average timelines to implement anti-counterfeiting measures? (Mention options depending on the type of projects, products, dosages, etc)

Packaging based solutions like light sensitive labelling, holograms and bar codes can be deployed rapidly i.e. within three to six months. Other methods like serialisation, SMS-based authenticity verification need development of some infrastructure but can be deployed within six to eight months. Detection systems like spectroscopes can be readily bought and enforced but represent major investments. But the fact remains that deployment of anti-counterfeiting technologies isn’t merely about the timeline, it is about the will power and the steadfastness of the top management. The objective, as in the case of most crime prevention measures, has to be to create a strong deterrent rather than enable 100 per cent detection. As the economics of these measures play out, the design of any anti-counterfeiting measure must aim to achieve near 100 per cent probability of detection and prevention rather than develop the ability to seek out every last counterfeit product.

We would be far better off if the points of leakage are sealed off through effective deployment of technology than by developing systems to identify the counterfeits in a sea of genuine drugs.

The patient is often the silent stakeholder in the counterfeit issue but often suffers the most. Are there any precautions that they can take?

Some precautions that patients need to take when procuring medicines are as follows:

• Check the physical appearance of the medicine (colour, texture, shape and packaging)
• Identify if the packaging has missing information such as lot no. or expiration date
• Check if the original packaging seals have been opened, damaged, repaired or altered
• Product labelling that contains misspelled words or looks different from the standard packaging
• Check to see if it smells and tastes the same when you use it
• Seek the help of your pharmacists or physician in case of any doubt
• If you suffer any severe/ secondary effect from the drug please contact your doctor

In the future, deployment of further anti-counterfeiting measures are likely to add a couple of steps to the purchase process, but patients need to be willing to take the additional precaution as it will lead to a radical improvement in our ability to tackle the problem. Also whenever noticed, any instance of counterfeit drugs of any form must be brought to the notice of authorities. An aware populace collaboratively working with the law enforcement and pharma manufacturers is the critical factor in eliminating this problem.

What does the upcoming conference, PatientSafe India, hope to achieve? What is the vision and goals of this conference?

One of the critical factors which will decide the fate of any anti – counterfeiting exercise is the ability to galvanise widespread collaboration across different stakeholders across government, law enforcement, manufacturers, distributors, retailers, hospitals and practitioners. Nearly every successful effort in thwarting counterfeiting has been the result of alignment and collaboration. This conference attempts to offer such a platform for various stakeholders to achieve this elusive alignment and collaboration through:

• Sharing of ideas and information
• Identification of key levers
• Development of joint action plans
• Presentation and agreement on areas of external intervention
• Target setting and progress monitoring