Do nutraceuticals and ayurvedic products/herbal products pass the animal and human trials before coming into the market? It is understandable that big products such as "Cystone" for himalaya have been tested but what about numerous others?
What kind of regulations control these kinds of products?
No herbal formulations would come directly basing on toxicity studies (inVitro) and invivo (animal studies) but not with clinical studies. because we are all using ayurvedic formulations from many years which are with out passing any clinical trials
But there are FDA standards to be followed for Pharmacognostic studies etc and safety studies rather than efficacy studies
There are no requirements for proving clinical efficacy, and the bar for safetey for these products is much lower than for a perscription or OTC drug approved by the FDA.
Now a days it is compolsary by FDA So clinical trils is now a days impoprtant. So many Ayurvedic drugs came in to marcket with its prooved efficasy.
No. FDA classifies nutraceuticals and ayurvedic products under the umbrella of "dietary supplements". Dietary supplements are not required to be reviewed and approved by FDA for their safety and effectiveness and, therefore, are not required to undergo the kind of preclinical testing you're referring to. In the absence of clinical trials that the manufacturer performed on their own initiative for promotional purposes, these products are required to have the following statement on their packaging: "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease." Go to www.fda.gov for more detailed information.
Dear Lisa , Ayurveda is main medical line of treatment in India So in India now it is compulsory because it is not under dietery supplement but it is under medicine. Thanks
Ashok sir, can you provide some standard industry protocols currently in use regarding this.
thanks.
Under European (more exactly, European Union/European Economic Area) medicines legislation, medicinal products containing herbal substances/preparations must fall within one of the following three categories to reach the market:
1. A product can be classified under traditional medicinal use provisions (‘traditional use’) accepted on the basis of sufficient safety data and plausible efficacy: the product is granted a traditional use registration (simplified registration procedure) by a Member State,
2. A product can be classified under well-established medicinal use provisions (‘well-established use’). This is demonstrated with the provision of scientific literature establishing that the active substances of the medicinal products have been in well-established medicinal use within the Union for at least ten years, with recognised efficacy and an acceptable level of safety. As a result the product is granted a marketing authorisation usually by a Member State or by the European Medicines Agency.
(While both classification have specific requirements, both regulatory paths involve the assessment of mostly bibliographic safety and efficacy data)
3. A product can be authorised after evaluation of a marketing authorisation application consisting of only safety and efficacy data from the company’s own development (‘stand alone’) or a combination of own studies and bibliographic data (‘mixed application’). As a result the product is granted a marketing authorisation by a Member State or by the Agency via the centralised procedure if all requirements are met.
This text obove is from:
http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000208.jsp
From this link you will find (much) more info on herbal medicines in Europe
bottom line: preclinical studies may be part of option 3(may be part, not necessarily have to) and will usually not be part of an application using option 1 or 2.
- Badges
- Science topic
- Similar topics
- Psychology