Forum recommends 'National Pharmacovigilance Centre' for complimentary medicine
A forum of renowned ayurvedic practitioners and users of complimentary medicine in the country has called upon the Ethics Committee of the Indian Council of Medical Research (ICMR) to work out a consensus in establishing the much-needed 'National Pharmacological Centre' for practitioners of complimentary medicine in the country.
The demand for such a regulatory body was made at the two-day international meet on Adverse Drug Reactions that was held at the YB Chavan Centre, Mumbai last week.
Spearheading the move were Dr Dinesh Kumar, pharmacologist and senior research officer, National Institute of Nutrition, Hyderabad, along with Dr Enna Bhat, panchakarma expert and Dr Ashok Vaidya, a clinical pharmacologist involved in ayurvedic research.
Dr Dinesh Kumar expressed deep discontent over the prevailing system in the country where there did not exist any law for Adverse Drug Reactions pertaining to complimentary medicine.
Given that close to 60 per cent of all deaths in the world occurred due to effects of Adverse Drug Reactions and that a distinct 35-70 per cent of the population from all over the world resort to use of complimentary medicine at some point or the other, it was necessary to draft local laws to tackle the ambiguous issue arising from the ADRs, emphasized Dr Kumar.
According to Dr Kumar, whatever little guidelines we practice and emulate are all effects of laws that have been established by our western counterparts. And while most of the prescribed laws might be of genuine interest to the nation, some might be present with severe drawbacks emanating from the system.
This can be gauged by the fact that in 2001, out of the several drug-related projects that were initiated by our western counterparts, almost 26 of them were initiated without any possible study or comparison on the Adverse Drug Reactions, confessed Dr Kumar.
Stressing on the present status of drug-safety issues in the country, Dr Kumar said that it had many disadvantages, starting with the fact that the country was devoid of any regulatory manufacturing process for herbal drugs.
Further a record of intentional or unintentional replacement of traditional herbs was not available; there were violations observed in the storage procedures; true herbal toxicity was under-reported and many practitioners were biased against reporting an adverse clinical event, noted Dr Kumar.
Earlier, according to Dr Kumar, the approach to alternative system of medicine was on a personal level with practitioners having their own farms, were more environment conscious, there existed no concept of bulk drug manufacturing and no possibility of any drug interaction. But in the current system, raw materials are being bought from vendors where chances of contamination are quite high; companies having nothing to do with complimentary medicines are taking keen interest in this branch of science resulting in no specific achievement and frequent interaction with allopathic drugs is being the talk of the day.
If at all the above had to be bought under control, a national committee in co-ordination with several other regional monitoring centres that would monitor the same, was very essential, argued Dr Kumar. And to achieve that a pre-market survey would be the foremost task that needs to be undertaken, for which currently there exists no indigenous system in the country, noted Dr Kumar.