Considering the rising acceptability of ayurvedic medicines in the country and taking the scope of commercial sale, the Ministry of Ayush should strengthen the pharmacovigilance programme (PvP) in ASU drugs, according to Dr P M Dineshkumar, associate professor in Dravyaguna, at KMCT Ayurveda Medical College at Kozhikodu in Kerala.
Pointing out the need of a system to monitor the safety of traditional medicines, he said the use of Ayurveda, Siddha and Unani (ASU) drugs has increased worldwide. But, there are chances for adulteration, preparation of counterfeit drugs, development of formulations that lack conceptual basis of tradition. Cultivation of medicinal plants based on tissue culture method for the purpose of increased commercial need takes away the natural quality of the plants and herbs. So, pharmacovigilance has to be introduced to ensure the quality of all traditional drugs.
While discussing with Pharmabiz as part of his research work on PvPI on ASU drugs, Dr Dineshkumar said it is not only the duty of the practitioners to ensure the safety of the medicines, but also of the manufacturers, users of medicines, health experts, governmental agencies, clinical centres etc. So, a concerted effort of all the stakeholders including the patients is required to guarantee the safety measures just like to safeguard the health of the people.
“WHO emphasized the need to include traditional medicines in the pharmacovigilance system and published guidelines on safety monitoring of herbal medicines in Pv systems in 2004. Considering these guidelines, the Union Ayush ministry has initiated measures to introduce activities for pharmacovigilance, but it is not working well though the government has made the Institute for Post Graduate Teaching and Research in Ayurveda (IPGT&RA) in Gujarat as the national resource centre for the programme,” he added.
According to him, if a monitoring system for the safety of traditional medicines is introduced, it will help for creating confidence in the modern scientific community and also in the followers of the traditional system. With this, the efficacy side of the herbal drugs can be assured and their acceptance can be increased worldwide. The problem of clinical trial will become part of this monitoring system, he observed.
Once the monitoring system is introduced, there is scope for improving the patient care and safety of medicines, keeping safety records of ASU drugs by hospital authorities, assessment of effectiveness and risk factors, encouragement of safe, rational and effective use of traditional medicines. Dr Dinesh said cases have been reported on adverse drug reactions (ADRs) and drug-drug interactions by the use of traditional medicines at various national and international forums. So, it is high the government of India introduced the PvP system for ASU drugs.