Date: 17-Feb-2020

Indian pharma keen on WHO policy brief for medicine traceability to stall warning letters from regulators & remain unscathed

Indian pharma is eager to ensure total adherence to norms to stall warning letters from global regulatory authorities. Here, it upholds the traceability policy brief which WHO issued recently. The industry sees that it would provide the much-needed relief during global audits where more often observations by global regulatory authorities and issue of alerts are based on poor adherence to the cGMP norms. The WHO policy brief features on the existing traceability systems which mandate the need for technology adoption to alert inconsistencies in product manufacture and supply chain management. The policy document also awaits industry comments before the month end. Here, WHO indicated the regulators of each of its Member States need to establish a suitable governance to implement the traceability system based on the maturity of the local supply chain and the capability of the stakeholders to efficiently fulfill verification requirements. Given the globalization of trade, health products are manufactured and distributed in complex supply chains. The products pass through many entities in transit to the patient as the product is manufactured in one country and distributed across borders to be marketed globally. As the supply chain becomes fragmented, the oversight capacity of national regulatory authorities becomes stretched. Effective oversight of the supply chain is weakened, raising the risk of substandard and falsified (SF) medical products and expiry dated drugs. These events lead to loss of public confidence. Hence WHO noted that there is a need to addresses such vulnerabilities and strengthen supply chain integrity and efficiency, with patient safety at the forefront. Incidentally, Kaushik Desai, pharma consultant in December 2019 along with Goutam Dutta, manager, quality, AN Pharmacia Laboratories penned down their views on risk assessment and strategy on pharma supply in ‘The Pharma Review’. Commenting on the WHO draft regulation on traceability Desai told Pharmabiz that it is important for the industry to upgrade, improve quality standards at the facilities to maintain data integrity. India being a member of the working group formed by WHO in framing this policy document is committed to bring its standards in line with global practices and support in meeting WHO target of universal healthcare for all by 2030. WHO has also pointed out that traceability technologies offer the technical possibility to track medicine supply chain from the manufacturing point to the location of dispensing and even the where it is administered to a patient. This according to Desai will only strengthen the real-time monitoring of the integrity of medicines in the supply chain. But this policy does not extend to APIs, excipients, medical devices and blood products, he said. In recent years, Member States have called on WHO to facilitate the exchange of experiences, lessons learnt and information about traceability technologies. Now the Member State have put in a mechanism on substandard and falsified medical products. Several technical documents are published to highlight the current scenario including the experiences other countries. However, a global framework or guideline is yet to be developed. There is also limited peer-reviewed published evidence on traceability systems implementation available to support policy development, said WHO noting that its current policy brief on traceability of drugs is designed to guide the National Regulatory Authorities (NRAs) to equip them on how-to develop norms.