August 09, 2011, 0800 IST – Source : Pharmabiz News
Keeping in view of the dangers to the lives of the masses, measures have to be strictly initiated to control the mushrooming of Clinical Research Organisations (CROs) in the country as most of the upcoming institutions are not following the ethical norms, according to Dr K Mohandas, vice-chancellor, Kerala University of Health Sciences (KUHS).
While inaugurating a national seminar on “effective intervention of pharmacovigilance in the Indian scenario” at Al Shifa College of Pharmacy in Malappuram in Kerala, Dr Mohandas said stringent norms are required to monitor the new CROs and the authorities must have a watchful eye over their functioning to sensitively assess whether they follow the ethical norms. He said multinational companies from abroad are looking at India as the hub of clinical trials, so pharmacovigilance has to be strengthened in our rural as well as urban areas.
He exhorted the CROs and the professionals participating in the studies to conduct the trials by strictly adhering to ethical values. According to the VC, the volunteers who are subjected for the study should be educated about the laws related to it.
Addressing a scientific session on “patient medication safety and pharmacovigilance’ that followed, Dr S Sriram, HoD, Department of Pharmacy Practice, College of Pharmacy, Coimbatore said it is high time India’s pharmacovigilance programme to be strengthened and the pharmacists of the country can play the major role towards that end. He opined that pharmacovigilance could easily identify the risk factors in the shortest time so that the harmful effects could be avoided or minimized.
Regarding patient safety, he said, it refers to the evaluation of medication errors that occur at the stages of prescribing, dispensing and administering drugs. It strives to educate clinicians and patients about the correct use of a particular drug. Drug safety and medication safety are subsets of patient safety. Medication safety is a strategy of medication administration which ensures “five rights,” that is, right patient, right medication, right dose, right route and right time, pointed out Dr Sriram.
In the seminar, Dr Surulivel Rajan from Manipal College of Pharmacy spoke on “pharmacovigilance in clinical trial and clinical practice.”
Managing Trustee of Al Shifa College, P Unneen presided over the function. Dr R Saraswathy, director of the College, Dr P Yahia, Principal, Dr K Mohammed Haneefa, vice-principal and Dr S Durgaramani, HoD, department of pharmacy practice spoke on various subjects.
More than 160 pharmacy students from various colleges participated in the national seminar and awards were given to the best poster and oral presenters.