1Assistant Professor, Department of Pharmacology, HIMSR, Jamia Hamdard, India
2Assistant Professor, Department of Anatomy, Faculty of Dentistry, JMI, New Delhi-25, India
*Corresponding author: Dr. Mohammed Imran, Assistant Professor, Department of Pharmacology, Hamdard Institute of Medical Sciences and Research and Associated Hakeem Abdul Centenary Hospital, Jamia Hamdard, New Delhi-62, India. E-mail: drimran@aol.in
Online published on 1 March, 2014.
Harmful medications in Indian markets are abundant. Although Pharmacovigilance Programme of India by Ministry of Health and Family Welfare have been started but weak processes of regulation by Central Drug Standard Control Organisation, which is the main regulatory agency, have resulted in a situation of regulatory uncertainties.
Recently, 59th parliamentary standing committee has tabled its report mentioning appalling findings of regulatory agencies-pharmaceutical companies-clinicians nexus in India. This committee randomly chose 42 drugs out of which 11 did not undergo phase III trials and 13 were not permitted to be sold in countries with matured regulatory bodies. Almost in 25 cases clerical staff approved drugs without any expert opinion.
In the time when pharmaceutical companies and academia are conducting clinical trials without regulatory approvals, the clinicians have no choice but to prescribe whatever is available in the market assuming that the drugs have necessary approvals.
Vigilant Prescribing, Drug regulation, Pharmacovigilance, CDSCO, Therapeutic misconception
