U Sudhakar Reddy
State government has made animal toxicity tests mandatory for export oriented Ayurveda drugs containing metals. Health Department has issued guidelines to Ayurveda drug makers in this regard.
As part of streamlining the system for licensing of patent and proprietary products of Ayurveda, Siddha and Unani medicines government earlier formed an expert committee which prepared guidelines.
As per the government order any metal or Rasa preparations should be subjected to animal toxicity for the export oriented products.
Pharmacopoeia guidelines should be followed for the formulations to be exported.
Health department said authentic purifying procedures of the drugs belonging to the group of rasas, maha rasas, dhatus(metals) should be strictly followed and procedure should be specified.
Government made clinical trials mandatory for the ayurveda drug makers.
"The proforma, utilised in the clinical trials of the formulation should be provided with the clinical reports copies. Reports of bio chemical investigation related to the patient population should be enclosed in the
clinical study," said a health official.
The ingredients pertaining to the formulation should be only from those mentioned in schedule one of Drugs and Cosmetics Act.
As per the new rule the ayurveda drug makers shall submit the chemical analysis reports along with data and photos as evidence pertain to the process. Report shall be provided from government or
State government approve or own laboratories. The label 'Heavy metals with in permissible limits' shall be
conspicuously displayed on the container of purely herbal and ayurvedic rugs. Ayurvedic Drug Manufacturers who do not have in house laboratory facility shall get their drugs tested by any approved
drug testing laboratory.
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