Are the new and more strict guidelines of European Union (EU), promising to keep close vigil on manufacture and sale of ayurvedic, siddha and unani (ASU) drugs a warning call for local manufacturers? While the new and strict guidelines of EU call for proper documentation apart from long clinical assessment and trial (spanning over 10 years) of all types of drugs prepared under indigenous medicine system in different countries across the world and the practice has been made mandatory for these drugs before they are sold in EU countries from May this year.
"The EU may not be a big player as far as business of ASU drugs are concerned, but the move is a clear indication of how the western countries have started to look at the safety and efficacy of indigenous drugs, putting the health of their citizens at the forefront," said Anand Chaudhary, regional co-ordinator, Regional Pharmacovigilance Centre for Ayurveda Drugs (RPC-AD), Banaras Hindu University. "It is also a wake up call for local manufacturers to start scientific validation and proper documentation of indigenous drugs that are being developed at various centres across the country," he added. It may be mentioned here that while India is the fourth leading manufacturer of pharmaceuticals in the world comprising over 6,000 licensed drug manufacturers apart from over 60,000 brands of medicines, the pharmacovigilance is still in infancy stage in the country. Even though the country has witnessed establishment of two zonal pharmacovigilance centres apart from eight RPCs and 30 peripheral centres to bolster pharmacovigilance in the last three years, report from various centres suggesting low reporting of adverse drug reactions (ADRs) from these medicines are enough to reflect lack of awareness in this regard. While a total of 114 cases of ADRs from ayurvedic drugs have been reported from different parts of the country in the period stretching from January 2010 to April 2011, the northern region of the country has drawn blank, failing to report even a single case of adverse drug reaction in the past 15 months. Also, as per reports of RPC-AD centre at BHU, only three cases of ADRs have been reported at the centre since its inception in 2008.
"The figure clearly reflects lack of awareness for reporting ADRs in the region and also sends strong warning and wake up call to the local manufacturers to pull their socks to promote scientific validation and initiate documentation for ASU drugs, if they are to become saleable in the world," says Chaudhary, who is also associate professor in the department of rasa shastra. He also emphasised that pharmacovigilance was basically meant to ensure post-marketing surveillance of ayurvedic products which might identify in ADR products, so that further improved version of ayurvedic product was available for the common man. "It is not meant for triggering any kind of rivalry or penalisation, but come up with safe drugs, much on the heels of the new guidelines of EU," he added.
Source:TNN
"The EU may not be a big player as far as business of ASU drugs are concerned, but the move is a clear indication of how the western countries have started to look at the safety and efficacy of indigenous drugs, putting the health of their citizens at the forefront," said Anand Chaudhary, regional co-ordinator, Regional Pharmacovigilance Centre for Ayurveda Drugs (RPC-AD), Banaras Hindu University. "It is also a wake up call for local manufacturers to start scientific validation and proper documentation of indigenous drugs that are being developed at various centres across the country," he added. It may be mentioned here that while India is the fourth leading manufacturer of pharmaceuticals in the world comprising over 6,000 licensed drug manufacturers apart from over 60,000 brands of medicines, the pharmacovigilance is still in infancy stage in the country. Even though the country has witnessed establishment of two zonal pharmacovigilance centres apart from eight RPCs and 30 peripheral centres to bolster pharmacovigilance in the last three years, report from various centres suggesting low reporting of adverse drug reactions (ADRs) from these medicines are enough to reflect lack of awareness in this regard. While a total of 114 cases of ADRs from ayurvedic drugs have been reported from different parts of the country in the period stretching from January 2010 to April 2011, the northern region of the country has drawn blank, failing to report even a single case of adverse drug reaction in the past 15 months. Also, as per reports of RPC-AD centre at BHU, only three cases of ADRs have been reported at the centre since its inception in 2008.
"The figure clearly reflects lack of awareness for reporting ADRs in the region and also sends strong warning and wake up call to the local manufacturers to pull their socks to promote scientific validation and initiate documentation for ASU drugs, if they are to become saleable in the world," says Chaudhary, who is also associate professor in the department of rasa shastra. He also emphasised that pharmacovigilance was basically meant to ensure post-marketing surveillance of ayurvedic products which might identify in ADR products, so that further improved version of ayurvedic product was available for the common man. "It is not meant for triggering any kind of rivalry or penalisation, but come up with safe drugs, much on the heels of the new guidelines of EU," he added.
Source:TNN
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