Karnataka's directorate of Indian System of Medicine has already initiated the practise of product dossier based licensing system for the last 10 years. Since the system of product dossier submission is already in force in Karnataka, the announcement by the Union Government has no impact on the manufacturers.

The state is perhaps the first in the country to follow the practise, Dr. KS Jayashree, technical expert, Department of AYUSH, Government of Karnataka and professor and head of the department, of post graduate studies in Dravyaguna, Government Ayurveda Medical College, Bangalore told Pharmabiz.

Manufacturers have to submit product dossier while applying for product license and the practise was inculcated when companies began seeking for certification in good manufacturing practises (GMP) or Schedule T. The directorate ensured that companies at no cost deterred product dossier submission. The units were asked to provide details of the product ingredients, specify the step-wise production process information apart from indicating the physical and chemical properties of the herbs utilised in drug production, explained Dr. Jayashree.

Around three months ago, the Karnataka Indian Medicines Manufacturers Association (KIMMA) teamed-up with the directorate of AYUSH, Karnataka to organise workshop for manufacturers, which primarily focused on product dossier submission formats required by the licensing authority to scrutinise while clearing products for production.

Since the practice of product dossier submissions are already enforced companies including The Himalaya Drug Company and KIMMA represented by medium and small sized manufacturers in Karnataka have appreciated the stand by the Union Govternment's Department of AYUSH to introduce the product dossier system for licensing ASU medicines.

Dr. Mitra, director, research and technical services, The Himalaya Drug Company, said, "The decision of the Department of AYUSH to introduce a product dossier system for licensing ASU medicines is definitely a move in the right direction. We appreciate the efforts of the government to create a stringent regulatory framework and delineate clear guidelines for the commercial practice of ayurveda, as it will impart solid credibility to this system of medicine both in the domestic and international markets."

"Himalaya has always abided by international regulatory standards and complied with strict quality parameters to give consumers very safe and efficacious herbal products. As such we welcome the government's decision to increase standardisation within this industry as it will benefit all players in the long run," she added.

Our association has also already advised the industry to follow self regulation and self certification on labelling requirements, informed JSD Pani, secretary, KIMMA.