Karnataka Directorate of Ayush will start issuing licenses for aqueous-based herbal extracts shortly. Although efforts of issuing licenses are in the preliminary stage, the directorate is keen to take on the task.
This will make Karnataka the second state in the country after Andhra Pradesh to issue the licenses for the segment. However, it is the first state in the country to grant the permission for the aqueous based extracts in consultation with the Union government. The Drugs and Cosmetics Act permits the same, but a separate license for the same was not scheduled.
The water based herbal extracts are used in all single ingredient formulations. For instance a herb like Ashoka or Ashwangandha is boiled in water and wheedled out. The contents will be tested for its appearance, efficacy and quality. So long, the State directorate was issuing licenses only for the production of ayurveda drugs. But now the move to issue licenses for water-based extracts comes in after repeated requests from the industry to streamline the herbal extracts sector, according to Dr TS Gopalakrishna, drugs inspector, Karnataka Directorate of Ayush.
"Solvents and hydro-alcohol extracts do not come under the purview of department of Ayush licensing cell. The Union government has been silent on this front for a while. In the case of Andhra Pradesh directorate of Ayush, they have granted the 'Gana Satva' license which means approval for concentrate substances based on purity and quality. Around 300-400 licenses have been issued till date.
The herbal extracts industry in the State approached the Karnataka Directorate of Ayush which in turn approached the department of Ayush, Ministry of health which permitted verbally to go ahead and include the aqueous-based extracts licenses.
The Karnataka Directorate is now in the process of reviewing the submissions of the aqueous-based extracts of Dhanawantri Botanicals in Malur district in the State. In fact, the company was the earliest in Karnataka to receive the production licenses and now will be the first in the segment to bag the license for aqueous-based extracts, informed Dr HY Rathod, drugs inspector.
Aqueous-based extracts will be tested for efficiency, bioavailability and its therapeutic content, according to a panel of ayurveda experts.
Globally, aqueous-based extracts are used extensively, but in India its use is nascent but is gaining importance going by the popularity of herbal extracts in the country and abroad. Amazonian Rain Forest Herbs in hydroglycolic extracts and pure expressed oils are exotic and functional for your cosmetic formulations.
These extracts are efficacious and all that the drug licensing authority needs to do is to certify the aqueous-based extract after ascertaining the purity and quality of the extract. The extracts are also far economical than the pure herbal extract retaining its value.