IP digitisation a booster for exporters

In what can be of immense to all stakeholders in pharmaceutical industry when it comes saving on costs and time, the Indian Pharmacopoeia Commission (IPC), an arm of the Union Health and Family Welfare Ministry, is all set to digitise Indian Pharmacopoeia (IP) which is a book of standards for all drugs that are manufactured and consumed in India. To improve the quality of medicines manufactured indigenously, Union Health Minister Dr Mansukh Mandaviya has on July 1, 2022 released the ninth edition of Indian Pharmacopoeia 2022, a book of standards for drug manufacturers in the country. It has four volumes that are quite heavy and cumbersome to carry around.

On that count, digitization will help stakeholders access IP from anywhere thus saving costs and time. On November 23, 2022, IPC invited tenders on government e-marketplace (GeM portal) from eligible IT firms for developing the portal, application development and data digitization or online content management for the project aptly named 'Digitization of Indian Pharmacopoeia'.

The Ministry's initiative in this regard is a welcome one as IP 2022 is quite bulky what with 92 new monographs for drugs, 12 new general chapters, 1,245 monographs for formulations, 930 monographs for active pharmaceutical ingredients (APIs) and dissolution specifications for all prolonged release formulations. Till date there are no such specifications for prolonged release formulations and it will definitely impact public health in the long term in a big way. Of the 92 new monographs, 60 are chemical, 21 vitamins, minerals, amino acids, fatty acids, three biotechnology-derived therapeutic products, four human vaccines, two blood and blood-related products, two herbs and herbal-related products and seven 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 maintaining 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.

There are several changes in IP 2022 that are bound which to have a positive impact on public health. These changes are certainly facilitating growth and expansion of the Indian pharma industry and research.

No doubt, the ninth edition of IP will be a step forward to delivering quality medicines. Several monographs and general chapters have been duly updated meeting the current global requirements and harmonizing with other pharmacopoeias like US Pharmacopoeia (USP), British Pharmacopoeia (BP) and European Pharmacopoeia (EP).

The harmonization of standards with global standards is expected to help IP to get recognized and accepted in foreign countries. India is the world's largest supplier of generic medicines and accounts for 20 per cent of the worldwide supply of generics by volume. The country ranks third in terms of pharmaceutical production by volume, 14th in terms of value (worth $42 billion). However, only four countries – Afghanistan, Ghana, Nepal and Mauritius- have accepted IP as a book of standards. 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. But, Indian Pharmacopoeia is still not recognized by these countries. On the other hand, USP, BP and EP are accepted by all these countries. Medicines to the US, the UK and to the EU countries are supplied by India, but they are reluctant to recognize IP. If IP is accepted by more and more countries, it will be a huge relief for exporters. For the merchant exporters, the medicinal products in IP can cater to overseas markets as they are. There is no requirement of applying for a separate production method. Like the supply in the domestic market, medicines manufactured in IP, can be bought and exported to IP-accepted countries, which will treat them like their locally manufactured drugs. But, to the non-accepted countries, a separate method of production has to be done in their quality and safety perspectives specific to their pharmacopoeia.

The government should now leave no stone unturned to ensure that Indian pharmacopoeia is acknowledged and appreciated worldwide. It is here that digitization of IP will help stakeholders access IP from anywhere. Besides, it will increase its reach and facilitate its simple use.

(The author is a freelance journalist with varied experience in different fields)