Pharmacopoeia roles and responses: A systemic resilience approach to COVID-19 pandemic

Ensuring the quality of medicines in India: An update on the development, modernization, and harmonization of drug standards in the Indian Pharmacopoeia

“…Pharmacopoeia constitutes a legally binding collection of public standards that serve to assess medicines' identity, strength, purity, and safety that can be expected and demonstrated at any time throughout their shelf-life ( Rastogi et al, 2022 ). The standards outlined in pharmacopoeia represent the minimum requirements that a drug must comply with throughout its shelf life.…”

“…The inclusion of monographs in the IP is based on specific criteria with priority given to drugs listed in NHPs and NLEM along with other clinically relevant drugs with significant market share. The development of monographs commences by drafting them based on validated analytical procedures and specifications approved by the regulatory authority and donated by the manufacturers to IPC ( Anonymous, 2021 , Rastogi et al, 2022 ). The drafted monographs undergo review by specialized EWGs having members from regulatory authorities, pharmaceutical industry, drug control laboratories, health authorities, and research organizations.…”

“…The IPC has prioritized setting standards for such drugs. For instance, the IPC has developed monographs on APIs and FPPs of Remdesivir and Favipiravir in collaboration with the pharmaceutical industries and were subsequently included in the IP Addendum 2021 ( Rastogi et al, 2022 ). Additionally, two new monographs viz.…”

“…Such efforts towards the monograph revisions gradually lead to monograph harmonization among the different pharmacopoeias and the establishment of uniform drug standards. This also alleviates the burden on the users who would otherwise need to perform analytical procedures using different specifications, thus paving the way for the globalization of the drug market ( Narula et al, 2014 , Rastogi et al, 2022 ).…”

“…To further upgrade the drug standards of the IP, monograph revisions were initiated with respect to the modernization of analytical procedures by including stability-indicating methods, the addition of test specifications on dissolution and related substances, and the revision of test limits. For instance, IP 2022 has witnessed the revised monographs updated with methods and specifications of UV test and benzene for isopropyl alcohol and isopropyl rubbing alcohol ( Rastogi et al, 2022 ). Furthermore, a gas chromatography-based test for related substances was introduced in the monograph on isopropyl rubbing alcohol to detect possible impurities in the hand sanitizers.…”