The Indian Pharmaceutical Association (IPA), West Bengal branch has urged the union health ministry to initiate immediate steps to implement the recommendations made by Prof Ranjit Roy Chaudhuri expert committee as it will go a long way in protecting the rights of the subjects in clinical trial.

IPA West Bengal branch vice president Dr Subhash Mandal said that though the government has accepted in-principle the report of Prof Chaudhuri committee, the government is yet to take any concrete step to implement the recommendations in letter and spirit. The government should implement the recommendations urgently as the whole procedure of the clinical trials needs to be changed and the rights of the subjects have to be protected. The Chaudhuri committee report will help solve all these issues, he said.

Mandal said that the safety of the subjects in any clinical trial is an important issue while conducting the trials. A recent report of a Parliamentary Standing Committee has also expressed deep concern over the safety of the subjects.

“In order to ensure safety of the subject and streamlining the clinical trials, three new Rules have been inserted in the Drugs and Cosmetics Rules since January this year, (one in January and two in February 2013). By these Rules, it has been made mandatory that before starting any trial, permission has to be taken from DCGI. The Ethics Committee (EC) has to be registered with the DCGI office before recruitment of any trial subject and the mode and mechanism of compensation for any injury or death during trial have to be prescribed. These are valuable points which need strict monitoring,” Dr Mandal said.

Regarding compensation to the trial subject, he pointed out that the central drugs standard control organisation (CDSCO) published a guideline for calculation of compensation to be paid to the trial subject or his legal heirs in case of trial related injury or death. The recommendation of the Chaudhuri Committee is also in the same line but varies in some points. However, the government has accepted the recommendations. The report also says that the CDSCO needs to be reorganized, upgraded and strengthened if it is to perform the various functions envisaged by it.

“Compensation need not be paid for injury or death due to totally proven unrelated causes. In all other cases of death or injury/disability, compensation should be paid to the participant or his legal heirs,” says the report. It also assures that compensation will be paid to the trial participant if any drug-related anomaly is discerned at a later stage and accepted to be drug related by a competent authority whether in India or abroad.

Mandal said a draft notification regarding video recording of the procedure of entire trial subject recruitment has been published and waiting for final decision. This will definitely protect the rights of the trial subjects.

“At present the entire situation is murky and creates confusion among the stakeholders. This situation needs to be settled quickly by making a balance between the rights of the subjects and the flexibility of the investigator,” he pointed out.

To educate the members of his association, IPA WB will organise a workshop on the concept ‘Clinical Trials-Recent Development in Science and Regulations’ in Kolkata, he said.