Quality, Safety, and Efficacy of Herbal Products through Regulatory Harmonization
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Quality, Safety, and Efficacy of Herbal Products Through Regulatory Harmonization Srbhosb C. Mondol, MPhorm, PhD (Phorm), FIC Senior Inspector of Drugs. Directorate of Drugs Control, Birbhum District Drugs Control Office. Sun, Birbhum. India Moitreyee Mandol, MPhorm, PhD (Phorn), FIC Lecturer, Department of Pharmacy, Jnan Chandra Ghosh Polytechnic, Kolkata. India
Key Words Herbal; Standard; Regulation; Harmonization; Pharmacopoeia Correspondence Address Subhash C. Mandal, MPharm. PhD {Pharm), FIC. “Nalanda.”Fartabad, Amtola {near Bhangabari), PO: Garia, Kolkata-700084. India {email: subhash.mandaldr @gmail.com).
Quality of herbal medicines is a great concern to consumers and regulators throughout the world. The quality of herbal medicines mainly depends on regulatory requirements of respective countries. To probe the role of regulatory standards and their harmonization in improving quality, safety, and efficacy, legislation on herbal medicines ofdiferent countries was analyzed. Results show that different countries have been changing and upgrading quality re-
INTRODUCTION Throughout the world, there has been an upsurge in the use of natural products. Presently they are classified into different categories. Natural products of herbal origin are also used in different systems of medicine. For example, herbs are used in allopathy, homeopathy, Unani, Siddha. and Ayurvedic systems of medicine in India. In China, medicines of herbal origin have been extensively and traditionally used since the Yin Dynasty. The status of natural products is changing due to incorporation of the principles of modern science and enforcement of strict regulations. For example, US FDA has approved herbal products as medicine. The recently published National Essential Drug list of China includes 102 traditional Chinese medicines in a list of 307 drugs. Herbal medicines are popular because of experience and the abundant availability of plants in India due to its varied climatic zones. India has around 45,000 species of plants, out of which 15,000-20,000 plants have proven medicinal value. The traditional system of medicine utilizes around 7,000-7,500 species in its formulations. Ayurveda uses 2,000, Unani 1,000,Siddha 1,300, Tibetan 500. and 200 varieties are used in modern medicine (1). Interest in herbal products has been increasing over the last few decades, not only in underdeveloped and developing countries but in the
quirements over the last few years, and those who have no legislation presently have started framing suitable legislation. Like other countries, lndia has also adopted prudent measures to improve the quality of herbal medicines. Though there is a general trend to incorporate stringent measures worldwide, there is little initiative to harmonize regulations, which is essential for providing quality herbal medicines globally.
developed countries. A large number of big pharma companies as well as many government institutions have started redirecting their business strategy by investing in research and manufacturing of her
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