In India drugs counterfeit market is growing drastically and to curb this menace; the government, industry and associations are ready to imply newer and better techniques. Nakul Pasricha, Vice-president, Authentication Solution Providers’ Association and Chief Executive Officer, PharmaSecure talks about the association’s agenda and also discusses about the company’s strategies and plans with Usha Sharma
Being the Vice-President of India’s first self-regulated non-profit association, Authentication Solution Providers’ Association (ASPA), what immediate steps you have set in your agenda and how are you going to execute them?
We have decided to actively work with various trade bodies. Some of them are as follows:
Presentation to sector associations: ASPA will be propagating the importance of ISO 12931 standards in the context of authentication methodologies with various national body association as well as industry-specific trade association such as Organisation of Pharmaceutical Producers of India (OPPI) OPPI, Indian Drug Manufacturers’ Association (IDMA) etc. educating them about ISO and GS1 standards and our activities.
Partnership with anti-counterfeiting association for mutual understanding: ASPA works closely with global authorities such as International Hologram Manufacturers Association (IHMA), Counterfeit Intelligence Bureau (CIB) and Interpol, as well as industry bodies in India such as FICCI CASCADE, CII, ASSOCHAM and Indian Institute of Packaging and plays constructive role in ensuring that its members uphold a high pedigree of business ethics and values as prescribed by the ASPA code of conduct. We will enhance our relationship with other anti-counterfeiting associations as well. As the Vice President of the association, I will provide my inputs and opportunities to fulfil these objectives. ASPA has formed a committee to develop highest standards for authentication solutions providers and being a member of this committee, I will provide my inputs on digital authentication solutions.
Tell us about the association’s governance mechanism and how does it work?
Formed in 1998, ASPA has a rich heritage of 16 years and is known globally as a regulated and ethical organisation. We have adopted the highest standards in terms of our election process. The term of the governing body is for two years. Five governing body members are elected by general members through a secret ballot election process at a properly convened meeting. This governing body is responsible for setting and implementing an agenda that meets the objectives of the association and drives the growth of the authentication solutions industry in India and around the world. There are checks and balances in the memorandum of association of ASPA that ensure proper governance and accountability.
How big is the anti-counterfeit packaging market and by what percentage it is expected to grow in 2015?
The estimates vary, but the anti-counterfeit packaging market is expected to grow to about $128 billion by 2019 at a CAGR of 14.1 per cent. (Source: http://www.packworld.com/trends-and-issues/traceability-authentication-serialization/anti-counterfeiting-packaging-market)
Global regulatory compliance issues have tarnished the image of Indian pharma companies in the global arena and counterfeit drugs are adding mileage to this damage. What needs to be done both by the government and pharma companies?
The Directorate General of Foreign Trade (DGFT) in India has already mandated and enforced barcoding on tertiary and secondary packaging for all exported drugs but serialisation on the primary packaging is yet to be implemented due to some resistance from the industry. ASPA would encourage the government to continue its leadership role in getting such authentication solutions mandated and rolled out. At the same time, solution providers (i.e. ASPA members) need to work closely with pharma manufacturers to develop and put in place technically sound and cost-effective solutions that don’t just meet a mandate but support the business objectives of the companies in question.
Which five things needs to be in place to fight against counterfeit menace?
The foremeost things that need to be in place to fight against the counterfeiting menace are awareness of the issue, government support, strict laws and enforcement of those laws, scalable, cost-effective and reliable technology solutions and value addition for industry — don’t make fighting counterfeiting a burden.
You are also associated with PharmaSecure. What services do PharmaSecure offer to the pharma fraternity and how useful are they?
PharmaSecure offers the following services to the pharma industry. They are
Regulatory serialisation: PharmaSecure has a proven track record of implementing quality solutions for markets like Nigeria, China, and South Korea. Our solutions require minimum deviation from existing processes and negligible down time of manufacturing lines.
Brand protection: PharmaSecure enables manufacturers to identify each consumer pack by applying unique codes directly on the packaging or using pre-printed labels. Consumers can verify the authenticity of this specific product by messaging the code to a pre-printed mobile number /short code, using our mobile apps or simply going to web portal. This technology can also be used to identify loyal customers accordingly reward them. Besides external controls, out solutions enable controls between brand owners and outsourced production/ packaging facilities.
Market intelligence: We use technology that associates a uniquely identified unit of product with the individual patient to help manufacturers understand key behavioural metrics of bonafide patients and their prescribers. Thus it provides the real-time, regional intelligence which is needed to confidently implement strategic change and monitor effectiveness of field force, etc.
What all authentication solutions do PharmaSecure offer. How big is the market and what are the drawbacks?
PharmaSecure is a US-based organisation that has been fighting the counterfeit drug problem in India for the past six years. By putting unique, random, alphanumeric codes onto each individual blister pack, bottle or injectable vial, PharmaSecure enables the verification of that product by simply SMSing the code. Over 1.2 billion products (i.e. one for every Indian citizen) have been protected to date through this technology, with close to 50 companies in India and other countries having already adopted the solution. With regulations being adopted by most governments, including India, such solutions that incorporate unique identification of products with verification, and add a layer of track-and-trace, will be required in order to meet the regulatory demands and also protect consumers. WHO has estimated that the size of the counterfeit drug trade globally is in excess of $75 billion. PharmaSecure is at the forefront of this battle and is working with other members of ASPA to ensure that authentication solutions can be adopted as widely as possible. Of course there are challenges such as consumer awareness, technology infrastructure in rural areas and low margins on medicines, but we have been working hard to address them.
Tell us the success review of the latest launch psConnect? What plans do you have to accelerate your reach through this product?
psConnect is PharmaSecure’s patient engagement offering, enabling brand managers or public health representatives to better understand patient behaviour, reasons for non-adherence and satisfaction levels with their product, as well as improve outcomes through information, communication and ethical incentivisation. We have seen widespread adoption across the pharma industry as well as in public health, with the Bill & Melinda Gates Foundation and USAID selecting PharmaSecure as a recipient in the “Grand Challenges in TB Control” initiative. PharmaSecure intends to aggressively grow this vertical within and outside India, aiming to be managing 100,000 patients’ health by 2016.
Tell us about the association’s future plans.
There is a wave of regulation coming over the next few years. India is already ahead of many countries, but the US, Europe, Brazil, Saudi Arabia, Iran, South Korea and China are all in the midst of implementations for regulatory compliance. PharmaSecure’s technology platform positions us well to help companies around the world meet these regulations. In addition, we continue to be interested in supporting patient engagement and public health endeavours using our psConnect suite and will be growing in this area of our business rapidly.