As a first step towards credibility and providing a scientific basis to the therapeutic claims of the alternate traditional medicines, particularly in the international market, India is in the process of standardising protocols for conducting clinical trials of the ayurvedic formulations.
“There are already guiding ethical codes, but the complexities of ASU (ayurveda, siddha and unani) medicines research necessitate a more elaborate set of guidelines that address a physician’s ethical and scientific responsibilities such as obtaining informed consent or disclosing risk during clinical trials,” a senior health official said, on the need for the guidelines.
More necessarily, the move comes in the wake of frequent complaints and rejection of the Indian ayurvedic medicines in the international market due to various grounds with the alleged heavy metal contents being one of them.
“Despite growing popularity of ayurveda medicines from India, the western world has doubted their efficacy in the absence of any scientific test. Hence as for allopathic drugs, a proper format for clinical trials of ayurvedic medicines has been constantly felt,” the official explained.
The clinical trials are a first step towards standardisation. The draft guidelines issued by the Health Ministry’s Ayush Department seek various norms for participants and setting up of ethical committees, compensation to be doled out and nature of tests that can be undertaken for the efficacy of the ayurvedic medicines.
For instance, it says, pregnant or nursing women should in no circumstances be the subject of any research unless the research carries no more than minimal risk to the fetus or nursing infant. However, no compensation amount has been specified in the draft guidelines.
“These guidelines are based on Central Drugs Standard Control Organisation (CDSCO) Document on GCP (Good Clinical Practices) Guidelines (2001) for Clinical Trials on Pharmaceutical Products. They should be followed for carrying out all ASU medicines research in India at all stages of drug development, whether prior or subsequent to product registration in India,” said the health official.
In a nutshell, he said, the guidelines seek to establish two cardinal principles: Protection of the rights of human subjects and authenticity of ASU medicine clinical trial data generated.
It is expected that armed with the scientific knowledge Indian ayurvedic manufacturers would be enhance their export potential which is presently pegged at Rs 11,500 crore (Rs 115 billion) while the domestic market size is estimated to be Rs 2,000 crore.
Source:The Pioneer
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