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Sandhya Shenoy, Associate Vice President, FDC

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API (active pharmaceutical ingredient) constitutes the most critical component of the finished dosage form. Successful treatment and desired clinical outcomes are governed by the right amount and quality of the API’s in the finished dosage form.

Healthcare is riddled with a plethora of issues including those related to adherence to treatment, patient compliance, which in turn is increasing the disease burden. Spurious drugs pose the biggest danger to health and could be indirectly contributing to the increasing menace of antibiotic resistance. Preventing counterfeit drugs and misuse is thus of prime concern.

The Drugs Technical Advisory Board (DTAB) has put forth a recommendation to the Health Ministry to make it mandatory to have barcodes on labels of API packages. The Health Ministry is contemplating to implement this recommendation. This is being sought as a measure to trace the movement and authenticity of API’s starting from the manufacturer throughout its journey in the supply chain. Implementation would provide a better solution to trace, prevent misuse and reduce counterfeit drugs. There have been several instances in the past where misbranded API’s have been passed off as made in India. Recently, the intelligence cell of CDSCO (Central Drugs Standard Control Organization) also came across manufacturers importing bulk drugs without valid registration and import license. Barcoding may serve as a deterrent to unscrupulous elements responsible for endangering human lives. The biggest advantage lies in the ability to capture timely and accurate information across the supply chain, helping to map the physical flow of material. In addition, barcodes are traceable and fully auditable, promoting theft deterrence.

Organisations are aware that implementing best practices will additionally save time and money in the long run. Industry is receptive and willing to implement systems and procedures to strengthen the supply chain. In order to make this happen, the DTAB and the Health Ministry together needs to evolve a process to seek inputs from all stake holders. There is also a need to have a continuous dialogue between industry and regulators to address any hurdles and clear the grey areas. A mechanism to ensure that feedback is well received and utilised to fine tune the implementation process would be most welcome.

This would mean investing in technology for the smaller API manufacturers, the returns on which may not be immediate. In order to have unanimous acceptance and success, the Ministry could consider providing incentives to smaller manufacturers. Most medium and large companies already have an information system such as ERP (enterprise resource planning) or warehouse management system. The new barcoding solution will need to be integrated with the existing system. This requires an understanding of how the data will arrive at the system’s database from the barcode label. Global manufacturers selling API’s in India need to be given sufficient notice to prevent supply disruptions to avoid shortages.

It would be advisable and in the larger interest to address all the pros and cons affecting the API business. This will help to avoid ambiguity as it happened in the earlier recommendations of barcoding on antibiotic packs and also provide much needed relief to industry on the uncertainty shrouding the implementation. Success can be assured only when we are well prepared and ready for advancements and make best use of technology. A half-baked idea would do the system no good and lead to poor acceptance and definitely a stomach ache!

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