Herbal Drug Regulation and Commercialization: An Indian Industry Perspective

Worldwide there is a growing demand for Ayurveda and other traditional forms of medicine.1 In India, about 80% of the rural population uses medicinal herbs or indigenous systems of medicine.2 It is estimated that nearly 960 plant species are used by the Indian herbal industry, and the turnover of the industry is more than Rs 80 billion. Herbal exports include medicines of AYUSH (Ayurveda, Unani, Siddha, and homoeopathy) products, which occupy a share of 3% of total Indian pharmaceutical export. Seventy percent of export from the herbal sector consists largely of raw materials and is estimated to be Rs. 10 billion per annum. Thirty percent of the export consists of finished products, including herbal extracts.3 However, India’s share in the global herbal export market is less than 1%.4 Although the AYUSH industry represents one of the oldest traditional forms of medicine in India, it has not been able to exploit the opportunities of the emerging market.5,6 To this end, the present study assessed the constraints that the Indian herbal drug industry is facing with respect to production, commercialization, and regulation for traditional or herbal drugs.

 

Although strengthening the regulatory mechanism with a view to ensuring quality of herbal medicines has become the prime concern for Indian drug regulators, drug manufacturers are grappling with increasing standards for herbal medicinal products. Fragmentation of the industry, lack of standardization of raw materials and finished products, inadequate research and development, slow pace of modernization, absence of focused marketing and branding, and inadequate emphasis on human resource development and education are the major reasons for slow growth of the Indian herbal industry. Proper implementation of DCA, development of more elaborate guidelines on quality control and quality assurance aspects, and development of marker-based standards are needed to produce safe and effective herbal medicines in India. Initiatives have been taken to address these issues by the Department of AYUSH. Schemes have been implemented to promote development of standardized herbal formulations. One such example is the New Millennium Indian Technology Leadership Initiative by the Council for Scientific and Industrial Research. Under this scheme, for the first time in India an Investigational New Drug application has been filed for an oral herbal formulation developed by extensive studies comprising finger printing, activity-guided fractionation, efficacy studies, toxicology, safety pharmacology, pharmacokinetics, and toxicokinetics for the treatment of psoriasis.

As evidence-based submissions are becoming increasingly essential for establishing the safety and efficacy of herbal products both in the domestic and the export market, more focus should be given on scientific and technological advancement in the field of herbal medicine. India must develop scientific cultivation, postharvest technology, processing, manufacturing, research and extension, patenting, and marketing strategy for medicinal plants and products. Regulatory harmonization becomes essential to mitigate the delays in commercialization across countries. Growing public demand for safe, high-quality, and efficacious integrative and complementary healthcare makes it imperative for AYUSH to urgently take steps in the fields of education, research, clinical medicine, pharmacopeial standards, health products, and services and improve regulatory mechanisms.