Clinical trial approvals accorded by International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) signatory countries could form the basis for such expedited approvals in India, feels Mashelkar Committee on Drug Regulatory Reforms. The committee has noted that ICH participating countries have elaborate and strict review processes and opined that Indian regulatory agency may consider approval of clinical trial applications of INDs (Investigational New Drugs) on the basis of approvals accorded by the regulatory agencies of ICH signatory countries.
This observation of the committee is an indirect acknowledgement of the need to harmonise its systems with ICH guidelines and thereby be part of global drug research community.
The ICH brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of product registration.
The ICH is for harmonisation in the interpretation and application of technical guidelines and requirements for product registration in order to reduce or obviate the need to duplicate the testing carried out during the research and development of new medicines. ICH aims at more economical use of human, animal and material resources, and the elimination of unnecessary delay in the global development and availability of new medicines whilst maintaining safeguards on quality, safety and efficacy, and regulatory obligations to protect public health.
The final recommendations of the Mashelkar committee has drawn heavily from the observations of a recent CII seminar on 'Clinical Research - Road Map for India' and has called for a single window clearance mechanism for approval of various applications concerning drug research and approval, including research materials. The committee is of the opinion that the policies and procedures presently applicable in the country for animal experiments need to be rationalized so that research projects are not unduly delayed or shifted out of country.
The committee observed that evaluation of data pertaining to new drugs and clinical trial approvals is necessarily multi-disciplinary in nature and it would always be imperative to seek advice and inputs from other institutions and external experts. It felt that the present cumbersome system of providing financial compensation is a major hindrance in taking recourse to external expertise. The committee recommended that the compensation be substantially eased and brought in line with the system followed by CSIR, ICMR etc.
Citing the current practice of outsourcing most of the clinical research clearance requirements, the committee wanted the office of the DCG (I) to have substantially enhanced evaluation capability with experts in pharmacology, toxicology, statistics, pharmaceutics and pharmaceutical chemistry forming part of its team.
However, the committee wanted Indian Council for Medical Research (ICMR) to keep watch over the systems and methodologies of various ethics committees to ensure GCP compliance in clinical research. The regulatory authority on the other hand should have a register of institutional review boards/independent ethics committees as well as investigators, the committee noted.