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Health ministry releases 9th edition of IP containing 3,152 monographs
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Laxmi Yadav, Mumbai
July 02 , 2022
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With an aim to improve the quality of drugs sold in the country, the Union health and family welfare ministry has released 9th edition of Indian Pharmacopoeia (IP) 2022 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.
Till date there are no such specifications for prolonged release formulations. It will impact public health in the long term in a big way.
Of the 92 new monographs, there are 60 chemical, 21 vitamins, minerals, amino acids, fatty acids etc., 3 biotechnology-derived therapeutic products, 4 human vaccines, 2 blood and blood related products, 2 herbs and herbal related products, and 7 phytopharmaceutical ingredient category monographs.
Besides this, IP 2022 also contains 652 pharma reference substances covering 70 per cent requirement of reference materials used for quality control in the country. Currently, there are 300 impurity standards in IP which are crucial for managing pharmaceutical quality. It also includes remdesivir API and injection monographs, favipiravir API and tablets monographs, 2DG API & powder & sachet monographs, Rapid microbiological testing—draft chapter. 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 USP, BP, EP, etc. The harmonization of standards with global standards is expected to help IP getting recognized and accepted in foreign countries.
The IP 2022 was released by Mansukh Mandaviya, Union minister of health and family welfare at IPC conference on July 1, 2022 in the presence of health secretary Rajesh Bhushan, Union minister of state for health and family welfare Dr Bharati Pravin Pawar Dr Rajeev Singh Raghuvanshi, secretary-cum-scientific director, IPC, Drugs Controller General of India (DCGI) Dr VG Somani, James Pound, British Pharmacopoeia and more than 350 registered participants from top pharma industries, state and central drug regulatory bodies, International Pharmacopoeia bodies (BP, USP), industry bodies like IDMA, BDMA, IPA, etc., and academia. The theme of the IPC conference was “Addressing Medicine Quality for Future.”
Speaking on the occasion, Dr. Mandaviya expressed his desire of getting India’s pharmacopoeia acknowledged and appreciated worldwide. He said, “We have become “Pharmacy of the World” by specialising in generic medicine formulation and manufacturing, and by supplying affordable medicine to the world. But we still need to strengthen research in the pharmaceutical sector. Till today, four countries – Afghanistan, Ghana, Nepal and Mauritius- have accepted IP as a book of standards. We should make a roadmap and move forward so that more countries accept our pharmacopoeia,” he noted.
Highlighting the role of government at international level, the health minister said, “As a result of the vision of our Prime Minister Narendra Modi and our work in that direction, the world has started recognising us and giving importance to our work and accepting it. We should focus on how our pharmacopoeia can take advantage of this focussing on international trade and industries based on our strength in indigenous medicines. Pharmacopoeia is important to develop a Swasthya and Samrudh Bharat, to maintain standard quality of our medical products- vaccines, medicines, equipment etc. and to keep an eye on the effect of these medicines on patients.”
Pointing out that India is the world's largest supplier of generic medication and accounts for 20% of the worldwide supply of generics by volume, he further said that during Covid pandemic, India has delivered accessible and affordable vaccines to 150 countries. “While delivering vaccines and other generic medicines to so many countries, we have never compromised with the quality and standards or delivered sub-standard or spurious drugs. India has earned global accolades as a result of this”, he added.
Chiming in with him, Dr Raghuvanshi, said “There are several changes in IP 2022 which will have a positive impact on public health. These changes are certainly facilitating growth and expansion of the Indian pharma industry and research. 92 new monographs for drugs have been added to IP 2022. There are 12 general chapters addressing different aspects of pharmaceutical quality management. Besides this, there are multiple improvements in existing monographs and general chapters in IP. Currently, we have 300 impurity standards in IP and these are crucial for managing pharmaceutical quality. We aim to add 500 impurities by the end of this fiscal. IP has been recognized by four countries—Afghanistan, Ghana, Nepal, Mauritius helping exporters to export the products to these countries without retesting them.”
Talking about new initiatives at IPC with high impact on public health, he said “IPC is developing digital IP which will be available to stakeholders in next 6-9 months. It will increase the coverage and facilitate simple use of IP. Currently we have four volumes which are quite heavy. We are increasing inventories and creating stakeholders’ awareness on impurity standards and its importance. Impurity limits have been harmonized with ICH. We have joined the Pharmacopoeial Discussion Group (PDG) on a global scenario which was earlier led by EP, Japan Pharmacopoeia and USP. We have been added this year as a test case along with a couple of more countries’ pharmacopoeia. After completion of one year, there will be a decision of PDG core group to make India permanent member or not. This group is driving harmonization activities among all pharmacopoeias at global level.”
“We are signing MoU with Ayush ministry and National Institute of Pharmaceutical Education and Research (NIPER), Guwahati in the area of herbal and phytopharmaceuticals development. Our MoU with NIPER also covers the area of pharmacovigilance,” he stated.
Dr Rajesh Bhushan said “Experience of handling pandemics since last two years made us realize that we were grappling with challenges of communicable and non-communicable diseases. We need to be always prepared for the pandemics which may come in future with alarming regularity. India accounts for 20 per cent of the world's generic supplies by volume. The country supplies 60 per cent of world’s vaccination demand and supplies 40 per cent of US generic demand. We rank third in terms of pharmaceutical production by volume, 14th in terms of value (worth USD 42 billion). The 9th edition of IP will be a step forward to delivering quality medicines to the public at large.”
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