The Union health ministry has tightened the norms on clinical trials after amending necessary rules regarding obtaining informed consent from the trial subjects and extending financial assistance to the victims, and has found two cases of violations in trials in the recent past.

The two cases came to the notice of the Drug Controller General of India (DCGI) were about the trial of drug Tadalafil in a hospital at Indore and the trial of an anti-cancer drug by Axis Clinical Research, Hyderabad, prompting the authorities to take action, sources said.

The DCGI initiated action following report t in respect of allegedly flouting of clinical trial norms at Maharaja Yashwant Rao Hospital and Mahatma Gandhi Memorial College, Indore where the drug Tadalafil was used for clinical trial for Pulmonary Arterial Hypertension (PAH).

“The office of DCG(I) directed CDSCO (WZ) on 12-07-11 to carry out a investigation to ascertain the facts. Accordingly an investigation was carried out by the office of CDSCO(WZ) and State Drugs Controlling Authority on 10-08-11 in respect of clinical trials conducted at M G M Medical college and associated M Y Hospital in Indore. As per the investigation report, a trial was conducted by Dr Anil Bharani and Dr Ashish Patel with tadalafil in patients with group-1 pulmonary hypertension without permission from DCG(I),” sources said.

“The study with Tadalafil was initiated on 18-09-05 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 10.06.2003. In view of above, vide letter dated 02-11-11 directed both the doctors namely Dr Anil Bharani and Dr Ashish Patel to stop the clinical trial of Tadalafil in Pulmonary Arterial Hypertension and restricted them to conduct any clinical trial for a period of six months,” sources said.

Another case that attracted action from the authorities was the trial of an anti-cancer drug by Axis Clinical Research, on poor people without proper informed consent. The investigations revealed that the firm conducted bioequivalence study on an already approved anticancer drug and there were certain irregularities with respect to informed consent process, review and decision making process of Ethics Committee.

“The permission granted to the firm for conducting bioequivalence and bioavailability study was suspended on 22.06.2011. Consequent to this, the firm, on 04.07.2011, has submitted corrective actions being taken by them including revised Standard Operative Procedures (SOP’s) for subject recruitment process, informed consent process, review and decision making process of the Ethics Committee. Based on further investigations and verifications, Axis Clinical Research, Hyderabad was granted 'NOC' to conduct Bio-equivalence study  subject to fulfillment of various condition regarding Informed Consent Process including documentation of the Informed consent process through Audio-Video means, functioning of Ethics Committee and investigators,” sources said.

In order to strengthen the regulations relating to clinical trials, following proposals  for amendments in Drugs and Cosmetics Rules, 1945 have been  approved by Drug Technical Advisory Board (DTAB) and a draft notification was published some time back to incorporate effective provisions for providing financial compensation to the trial subjects in case of trial related injury or death.

Another step in this regard was enhancement of responsibilities of Ethics Committee, Sponsor & Investigator to ensure that financial compensation as well as medical care is provided to the trial subjects who suffer trial related injury or deaths. Amendment was also made on the format for obtaining informed consent of trial subjects to include the details of address, occupation, annual income of the subject so as to have information regarding socio-economic status of the trial subjects.