Restricted from conducting any fresh drug trials for next six months

Two Indore-based doctors have been restricted by the Drug Controller General of India (DCGI) from conducting any fresh drug trials for the next six months, after they were found guilty of conducting illegal trials.

This was confirmed by Union Health Minister Ghulam Nabi Azad in reply to Bharatiya Janata Party MP Mahendra Mohan's question on December 20 last year.

The two doctors — Dr. Anil Bharani and Dr. Ashish Patel of the Maharaja Yashwantrao government hospital — were found guilty of testing the drug Tadalafil, used to cure erectile dysfunction, on patients with pulmonary arterial hypertension.

This is probably the first case in India where penal action has been ordered by the DCGI against practising government doctors.

The issue was raised by medical activist Anand Rai who levelled the allegations regarding the illegal trials in several local news reports.

“The study on Tadalafil in Pulmonary Arterial Hypertension (PAH) patients was initiated on September 18, 2005 when the drug was not approved for the said indication in the country. However, the drug was approved in the country for another indication — male erectile dysfunction — on June 6, 2003. In view of above, this office vide letter dated 02-11-11 directed both the doctors to stop the clinical trial of Tadalafil in Pulmonary Arterial Hypertension patients and restricted them to conduct any clinical trial for a period of six months,” Mr. Azad stated in his reply.

Madhya Pradesh has witnessed a raging controversy over illegal and unethical drug trials being conducted by government doctors and Indore has had the dubious distinction of emerging as the hub of such trials.

The government had recently fined 12 government doctors a sum of Rs.5000 for conducting illegal drug trials on children and mentally challenged persons. The government action was, however, slammed by the opposition Congress as a “joke and insult to the victims” because of the meagre fine amount.