Clinical Research Organizations (CROs) need to embark on a mode of self regulation until such time the government redrafts the Clinical Establishments (Registration and Regulation) Bill 2007 to include the component of clinical trials on patients, according to Dr M Venkateshwarulu, former DCGI.

The present guidelines can be interpreted as law. The regulations are evolving and the Bill is on the anvil.

In a discussion titled 'Translating Experience into Reality Programme' under the section 'Legal and Regulatory Framework' organized by the Indian Society for Clinical Research in Bangalore, Dr Venkateshwarulu said that going by the increasing number of clinical trials in the country and in the absence of a dedicated regulation for the sector, CROs need to create a stringent in-house legislation whereby they will be able to ensure right clinical practices during the conduct of a trial.

In this connection, the former DCGI called for a need for training of the Ethics Committee members which is the nodal point that approves the conduct of a trial.

Although Form 29 of the Drugs & Cosmetics Act calls for test of drugs and condition of license it does not go beyond the purview of inspection. From a regulator's perspective, clinical trial sector is a sensitive area because it involves multidisciplinary issues including the need for competent personnel. The Ethics Committee members are of a certain standing and recognized as the monitoring agency who is in-turn supervised by the regulatory body which also need experts, stated Prabhakumar, former Karnataka deputy drugs controller, and presently international procurement officer, Manipal Cure & Care.

In the absence of a regulation and the need to ensure a faster implementation of a law, it is important for CROs to be recognized as an entity. For this, they need to define their activity along with the conditions for compliance to Schedule Y and describe their qualifications to get themselves recognized under the Drugs & Cosmetics Act, he added.

"There are several grey areas in clinical trails and the sector will need to gear up to adhere to stringent rules which will begin with training. Otherwise CROs will be under the threat of breach of regulations," informed Prabhakumar.

Dr Nagasubramanium, consultant urologist & member secretary, Ethics Committee, Manipal Hospital, Bangalore said that there is clearly a poor design of the Informed Consent Forms (ICF). There needs to total transparency in patient recruitment and how the consent is taken.

Voicing their views on the need for rules CROs at the event stated that DCGI needs to have a list of Ethics Committee which provides details of the members and trials carried out. This would provide the sector more information on the available expertise during selection of the Committee.