Initially, the quality control certificate for ayurvedic medicines will be voluntary. Later, it might become binding on all products to have a quality seal.
Given the high demand for herbal medicines in India and abroad, the Centre has decided to run all ayurvedic products through stringent quality control measures. As a result, all ayurvedic products might need to get validation from the Quality Council of India and products that clear the test will get the “AYUSH” seal for purity and good manufacturing practices (GMP).
The health ministry estimates that there are about 9,000 ayurvedic product manufacturers, but only 30% of these follow the GMP. “The department of Ayush has been exploring the possibility of introducing a voluntary product certification scheme for selected Ayush products to enhance consumer confidence. To begin with, we have kept it a voluntary certification scheme, but shortly we plan to make it mandatory for all ayurvedic products,” said a senior official from department of Ayurveda, Yoga, Unani, Siddha and Homeopathy (Ayush), ministry of health and family welfare.
There will be two criteria for certification. One is the Ayush Standard Mark, which is based on how well a product complies to domestic regulatory requirements. The other is Ayush Premium Mark, a certification of good manufacturing practices in line with WHO guidelines for the international market. The premium mark will have stricter regulations than the domestic criteria. For the time being, this certification is available for herbal products only. Any manufacturer wanting to qualify for the premium mark will first need to comply with the domestic regulation.
The procedures and techniques used in the manufacture and quality control of herbal medicines are vastly different from those used for conventional pharmaceutical products. Because of the inherent complexity of naturally grown medicinal plants and the variable nature of cultivated ones, the production and primary processing has a direct influence on the quality of herbal medicines.
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