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Global Pharmaceutical Compliance Landscape

While Indian pharma exports were regulated years ago, the time has come to start a new era for anti-counterfeiting domestic regulation. In 2011, the Government of India had stressed on the fact that there is a need to protect the reputation of Indian Pharma exports and of the industry overall. This resolution resulted in the implementation of a scientific method of segregation for all export drugs. This ensures that the firsts step towards protecting patients around the world are taken care of, however when we look at the domestic market, lack of any such compliance method makes the 1.33 Billion population at risk from unlicensed and spurious drugs. In 2018, the Drugs Technical Advisory Board (DTAB) passed a recommendation that the top 300 pharma brands in India should come with an anti-counterfeiting solution. What was meant by this solution was namely an application which would of a unique code to each consumer-level pack. This would be supplemented with a SMS-based authentication for that code. However, unlike the case for products made for exports, this was a voluntary effort, which let to very low adoption.
Though there have been several concerns raised by the Pharma companies regarding the adoption, however all the stakeholders, namely, the regulators, pharma companies, solution providers and consumers, have to come together on a single platform to stop the spread of the spurious and sub-standard medicines.
When one looks at the global standard landscape from a Digital perceptive serialization as a new GS1 regulation has slowly emerged as a single global standard across the pharmaceutical industry. There exists a wide variety of technologies to physically differentiate one unit product from another, such as tamper-evident, tamper-proof, overt and covert features. All these options and more are readily available however there is a need for the industry and the government of working together. The government can help by incentivizing the adoption, this would intern inspire in R&D bringing in new-generation solutions. A healthy overall collaboration is the key for the adoption, as this would mean companies can strike a balance between quality and affordability.
The first initiative of the voluntary anti-counterfeiting solution came in 2018, it is the need of the hour to have a mandatory solution. As with every major technological leap, there are bound to be some challenges — of complexity, affordability, the technical environment being ready, but these can be overcome. For example, if there arises a situation where there is a technical challenge, such as the server does not perform at the optimal level, the companies can be allowed for an extension if needed. Steps like these and more can lead to a robust model which would focus on patient safety and the quality of medicine.
In 2009, there were no such global effort towards addressing the counterfeiting problem. It was way back in 2011, when the Directorate General of Foreign Trade (DGFT) had issued a notice announcing the implementation of the track and trace system using the barcode technology as per GS1 standards, a move which even predated USA which came out with its legislation in 2013. It is time that India again take the first step and get all the stakeholders in the supply chain to participate in a single product verification system. This would ensure patients would receive only genuine pharmaceutical products. Another pressing concern for the companies is the lack of visibility of product movement across their supply chains, which in turn compounds the chances of large quantities of inferior-quality medicines from reaching the retailer’s shelves.
In such a scenario, the solution adopted needs to cater to both the physical and digital solutions, together. The physical aspect caters to the tangible front which gives individuals an option of physically verifying the purchase. While, the digital solution provides a combination of security, connectivity and data. A combination of both can help both companies and government with targeted data, which can be used for public health purposes.


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