Ayush mandates efficacy proof for ayurvedic goods

After ayurvedic products came under the scanner of authorities in markets like Europe, the department of Ayush (Ayurveda, Unani, Siddha and Homeopathy) has mandated furnishing of clinical evidence to prove safety and efficacy of formulations that contain ingredients such as heavy metal. Though the industry has welcomed the move, it is worried about the delay in getting licenses and has asked more time for compliance.
Under the 158B guidelines issued under the Drug and Cosmetics Act, 1945, patented and proprietary ayurvedic, unani and siddha products with ingredients such as heavy metals and microbial load prescribed under schedule E (1), are mandated to prove their safety and efficacy for securing license. For this, the ingredients have to be tested in accredited labs and clinical trials should have been conducted on the product to prove efficacy.
Classical products can still easily receive licence if they have the ingredients prescribed by ayurvedic, unani and siddha texts.
While banning ayurvedic products, Europe had insisted on clauses like the drug should be manufactured in facilities compliant of EU-good manufacturing practices, drug has to be in use for at least 30 years, of which at least 15 years have to be in an EU country and clinical evidence of safety and efficacy have to be furnished.
“The Ayush’s move is good for ensuring the quality of ayurvedic products, especially when they are exported to overseas market. This will also bring in standardisation of procedures,’ said S Sajikumar, managing director of Dhathri Ayurveda.
“In Ayurvedic prescriptions, heavy metals too are used and studies on efficacy will give an explanation to this too,” he said.
However, the tests are causing delay in procuring license for ayurvedic products, said Vijay Kumar, general manager, new ventures of Arya Vaidya Pharmacy.
According to Chandrakant Bhanushali, general secretary of Ayurvedic Drug Manufacturers Association, the industry has asked for two more years for compliance. The awareness level has to increase and the capacity also has to be built. “We are seeking the help of the department to conduct training programmes for the manufacturers,” he said.