Ronald Piervincenzi, CEO, United States Pharmacopeia, said there is a need to strengthen regulatory ability to conduct quality assurance, leading to more diversity in the supply chain. This will help the pharma sector become stronger.

Delivering his address at BioAsia2021 on the theme “Move the Needle”, he said US Pharmacopeia (USP), was establised in 1820 and in over 200 years, its focus has been on ensuring the quality of medical supplies and the supply chain.

Globally, in 2020, US Pharmacopeia managed to ship over 22,000 standards across facilities in different countries, which play a major role in ensuring quality, he said.

Its second site is located in Hyderabad and has 20 per cent of the global staff.

He said USP has identified key actions to secure a more resilient supply chain by fostering more supply chain diversity. The pandemic has forced companies to invest more in manufacturing capacities for continuous supply of critical medicines.

One of the key focus areas for USP is to enable more transparency and pave the way for data-sharing, apart from strengthening the regulatory systems and quality assurance globally.

He said one of the root causes of drug shortage is lack of quality. Reports suggest that about 43 per cent of shortage is due to quality issues.

‘Just in time’ manufacture

Regarding new vulnerabilities in the supply chain of drugs, he said it is due to greater complexity of the upstream supply chain. There is increase in pressure for margins, particularly for generics, and there are inadequate incentives for quality. In addition, there are regulatory and logistical hurdles that prevent agile responsiveness to market events.

All this has resulted in “Just in Time” manufacturing with little redundancy to absorb demand or supply shocks. There is increased outsourcing of ingredients and even final product manufacturing. Further, the lack of transparency is a result of inability to take any negative shocks. All these are responsible for some of the problems in the supply chain, he said.