Dr Rajiv Singh Raghuvanshi , secretary-cum-scientific director, IPC, in an exclusive interview with Shardul Nautiyal, tells how Indian Pharmacopoeia (IP) is evolving and its role in quality assurance of exported drugs for maintaining India’s credibility as the Pharmacy of the World.
The Indian Pharmacopoeia Commission (IPC)’s digitization plan for Indian Pharmacopoeia (IP) will widen the subscriber base of IP in an immense way, which in turn, will help develop quality mindset among drug manufacturers and other stakeholders, said Dr Rajiv Singh Raghuvanshi, secretary-cum-scientific director, IPC while speaking on the sidelines of the recently concluded 72nd Indian Pharmaceutical Congress in Nagpur.
What is the current status of IP and its harmonization with global standards?
IPC today has specifications which are more or less similar to international standards with reference to monographs and reference standards. It has exclusive monographs for antiretrovirals and Covid medicines today. Besides this, IPC is now a member of the Pharmaceutical Discussion Group (PDG). Therefore, the harmonization of Indian standards with global standards is also required to help IP getting recognized and accepted globally. IPC is set to harmonize 31 general chapters and as many excipient monographs of IP with PDG in three phases. The first phase will start from December 2024 and the last phase from December 2028. IPC has been selected by PDG for its year-long pilot for global expansion. The year-long pilot will facilitate harmonization of IP’s general chapters on Tablet Friability and Optical Microscopy with European Pharmacopoeia (EP), the Japanese Pharmacopoeia (JP) and the United States Pharmacopoeia (USP) which are members of the PDG. Today, the IP is at par with other Pharmacopoeias like the USP and the British Pharmacopoeia (BP) among others. It is noteworthy to say that IP today covers around 98% of National List of Essential Medicines (NLEM) which has 384 drugs under its ambit.
What is your opinion on the quality of medicinal products exported from India amid negative media reports?
The World Health Organisation (WHO) has also released an urgent call to action to countries and the stakeholders to prevent, detect and respond to incidents of substandard and falsified medical products.
State Drug Controllers (SDCs) can play a major role in creating awareness regarding IP for enabling quality mindset among manufacturers amid negative media reports about the adverse events related to the over-the-counter cough syrups with confirmed or suspected contamination with high levels of diethylene glycol (DEG) and ethylene glycol (EG) exported from India to Gambia and Uzbekistan. Monographs are already available for these drugs and the excipients in IP and therefore Indian manufacturers have to religiously comply with the same in order to achieve drug efficacy and safety. Following testing as per the monographs will solve the problem of drug quality effectively. Quality mindset is surely bound to develop if the manufacturer is using monographs, reference material and impurities provided by the IPC. The IPC is in the process of educating all the stakeholders regarding the same and also trying to focus on educating MSMEs first.
What are the other initiatives of IPC and the way ahead?
IPC is an autonomous institution under the Union Health Ministry to deal with matters relating to timely publication of the IP. The IP is the official book of standards for drugs to specify the standards of identity, purity and strength of the drugs imported, manufactured for sale, stocked or exhibited for sale or distributed in India. The IPC has published draft monograph revision proposals for stakeholders’ recommendations and comments by February 20, 2023. These are to be included in Indian Pharmacopoeia (IP) Addendum 2024 with tentative effective date of April, 2024. In order to improve the quality of drugs sold in the country, the Union Health Ministry released the 9th edition of IP 2022 in July last year containing 92 new monographs for drugs, 12 new general chapters, 1,245 monographs for formulations, 930 monographs for active pharmaceutical ingredients (APIs) as well as dissolution specifications for all prolonged release formulations. This has led to the total number of 3,152 monographs in the current edition of IP. Several monographs and general chapters have also been revised to update them as per current global requirements and to harmonize with other pharmacopoeias like the USP and the BP among others.