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“This global pandemic showed the unpreparedness of the pharma and healthcare sectors to tackle global calamities such as the Covid-19,” according to KV Surendranath, Senior Vice-President, Global Sites, US Pharmacopeia (USP).
He told BusinessLine there had been disruptions in supply chain and manufacturing globally in the wake of the dreaded virus spread. There was a lag period in the supply chain between January and March due to the spread of Covid-19 and it still has not attained normalcy, Surendranath said.
Many of the countries, including India, depend on China for their APIs. “Moreover, the capacities of manufacturing of certain drugs, are not built to serve the huge quantities required during a pandemic such as Covid-19,” the USP executive said.
Shortage
Stating that many countries are in a “panic,” due to possible shortage of drugs which are essential for the treatment, he said: “This has led regulatory agencies approving procurement of pharmaceutical materials from manufacturers which are either not approved or have regulatory issues. This could lead a compromise on the quality of the medicines.”
Additional precautions might be required to ensure that the medicines procured from unapproved sources are of good quality, he added.
On its part, the USP is supporting scientists, developers and manufacturers worldwide to accelerate the development of safe and effective Covid-19 vaccines, medicines and other treatments. It is developing insights on current vulnerabilities in the supply chain and devising ways to strengthen it for the future.
“During the Covid-19 pandemic, uninterrupted access to USP’s quality standards and support services is critical to helping manufacturers, scientists, healthcare practitioners and regulatory bodies continue protecting public health,” Surendranath said.
Medical monographs
Referring the USP’s initiative on modernisation of medical monographs which has been named as `Up to Date’, Surendranath said it had been a ‘top priority’ initiative for USP during 2015-2020 cycle.
This initiative has been huge, modernising over 3,000 monographs in five years involving 26 scientific expert committees and USFDA and other regulatory agencies worldwide.
“One of the unique features of this model is the development of more comprehensive and optimised procedures suitable for multiple sources. Majority of our monographs are now up-to-date with latest methods,” he said.
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