Even after eight months lapsed since the Kerala government assigned the department of drugs control to prepare a set of guidelines for the formation of a ‘state clinical trial registry’, the crucial decision of the government continues to remain in files with work on the project yet to begin.
The government had entrusted the department with the task of preparing the guidelines in March this year following the recommendation of a committee. The time given for the groundwork was two months.
However, the state drugs controller, P Hariprasad told Pharmabiz that the work is progressing, but unable to announce a date when it will be completed. The government’s decision to formulate a separate clinical trial registry had come in the wake of news reports that several hospitals conducting clinical trials were violating the principles of human research ethics.
While working out the plan, government had felt that the formulation of a Registry would curb the unethical practices in clinical trials by these centres. There was report that illegal clinical trials were being conducted in certain centres by associating with pharma companies.
Although no action has been taken form the part of DC department as of now, the drugs controller said the particulars in the Registry will be analogous with the state chapter of the Clinical Trial Registry of India launched by the Central Drugs Standard Control Organisation (CDSCO). However, there will be modifications and updating of facts.
“All the ADCs have been assigned to coordinate with the doctors, hospitals and technical experts. The preparation of guidelines is a serious thing and cannot be approached easily. So, an exact date for the completion of the work cannot be announced now”, he added.
According to sources in the health department, the Registry would include the study details, information about the hospitals and the clinicians involved. It will also cover details of the patients and the type of researches conducted on them.
There was a report that the subjects on whom the studies were conducted had been recruited from medical camps organized in some villages. This had compelled the government to go with a plan of formulation of a separate Registry. But it is unlikely to materialize in the near future, as per information received.