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INDIAN PHARMACOPOEIA AND ITS ACCEPTANCE

Ramesh Shankar
Wednesday, August 10, 2022, 08:00 Hrs  [IST]

The Union Health Ministry has recently released the 9th edition of Indian Pharmacopoeia (IP) 2022 containing 92 new monographs for drugs, 12 new general chapters, 1245 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 chemicals, 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. So, there are a total number of 3152 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 ministry deserves kudos for releasing the latest version of the pharmacopoeia as it is important to maintain standard quality of medical products - vaccines, medicines, equipment, etc. and to keep an eye on the effect of these medicines on patients. Definitely, the 9th edition of IP will be a step forward to deliver quality medicines to the public at large.
It is a well known fact that India has become the world's largest supplier of generic medicines and accounts for 20% of the worldwide supply of generic drugs by volume. India ranks third in terms of pharmaceutical production by volume, 14th in terms of value (worth USD 42 billion). India exports, mainly generics, to more than 250 countries and one out of the three drugs consumed by a patient in any part of the globe is from India. Quite aptly, India is known as the ‘pharmacy of the world. But unfortunately, so far only four countries - Afghanistan, Ghana, Nepal and Mauritius -have accepted IP as a book of standards. Except these four countries, Indian Pharmacopoeia is still not recognized by other countries. On the other hand, USP, BP and EP are accepted by all the countries. Medicines to the US, the UK and to the EU countries are supplied by India, but they are even now reluctant to recognize IP. If IP is accepted by more countries, it will be a huge relief for the exporters as it will help the pharma exporters, including the merchant exporters, to export their products to these countries without retesting them. The Central government is now in talks with UAE government to include IP in the standards of pharmaceuticals authorized in UAE with an aim to boost export of Indian drugs to the Emirates. In UAE and in the GCC countries, 40% of the drugs used by people are made by Indian companies, not in IP standards but in the pharmacopoeial standards of the USA or UK or the European Union. For accepting IP as an international pharmacopoeial standard, the government of India has to convince the countries in the world about the quality attributes of Indian drugs. Now, the government should take immediate steps to widen the reach and acceptance of IP as a book of standard.

 

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