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IPC aggressively working to enhance quality standards of herbs and fractions
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Nandita Vijay, Bengaluru
July 29 , 2021
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The Indian Pharmacopeia Commission (IPC) is now aggressively working to enhance the quality standards for herbs and fractions. The Commission has accorded considerable importance to this going by the growth of phyto-pharmaceuticals and wellness products like nutraceutical supplements during the ongoing Covid-19 pandemic.
In 2018, India accounted for a total of 166 monographs. As per the IP 2021 addendum, it is 172 monographs. There are many more botanicals and herbs used in India with a need to have more monographs in IP on them.
Noting that IPC is continuing its effort in the field and with a view to sensitize and create more awareness, Dr DBA Narayana, chairman: Committee on Herbs & Phytopharmaceuticals, IPC, spoke at a national workshop on Monograph Development for Herbs and Herbal Products for IP organized by the All Pharmacognosists & Phytochemists Association (APPA).
The globally attended webinar of 1,963 attendees had Dr TV Narayana, president, Indian Pharmaceutical Association in his opening remarks draw the need for quality monographs in IP as more herbals are being used for the treatment of Covid-19 to enhance immunity with some of them proving to have antiviral and antipyretic properties for faster recovery of infected patients.
Dr V Gopal, principal, College of Pharmacy, Mother Theresa Research Institute of Health Sciences, Puducherry, said that the pharmacognosists and phytochemists have to get involved and the workshop on Monograph Development for Herbs and Herbal Products for IP is a step in the right direction to give guidance on the areas of work that can be pursued by them.
Dr Narayana who has zealously worked in this area, said that those Pharmacognosists & Phytochemists developing monographs, he would help in procuring marker compounds required.
With a global resurgence in herbals, even the USP, BP, EU also have introduced such monographs. However Indian Pharmacopeia meets the need to objectively assess quality standards. The monographs have a regulatory aspect too. Mere presence of a monograph in IP does not mean its approval as a drug. It would need to be evaluated as per Rule 122A, B, C of Drugs & Cosmetics Act. IP monographs provide standards for use of the herb/herbals as a drug/ingredient in health supplement/nutraceuticals and cosmetics, said Dr Narayana.
The key advantages of monograph inclusion in IP is that it provides confidence of safety and quality to the user. It reduces and eliminates loss as both buyer and seller. Indian Pharmacopeia has been accepted for registration by other countries. For instance, USP, BP and EP have adopted Indian herbs, processed herbals IP monographs and reproduced in their pharmacopoeias. Therefore we have received a global recognition.
Further IP monographs supports researchers to use material of defined quality in human studies. It has opened up business opportunities for isolation and supply of marker compounds which is taken up by startups, said Dr Narayana.
IP is a useful reference manual for students and researchers. The criteria for inclusion in IP is that the herb should be available in the Indian market. There should be a definite botanical identity, non-controversial, and be specific to the species. It should be sustainable in its availability with known safety profiles with chemistry known of at least one chemical compound whose structure is confirmed, he said.
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