The Department of Biotechnology (DBT) has initiated consultations among all stakeholders within the government and private sector to evolve clear guidelines and procedures in clinical research. The idea is to frame appropriate rules and procedures to support contract research services through stakeholder consultation.
The latest of such initiative is to take place on May 23 in Delhi when DBT join hands with Confederation of Indian Industry (CII) for a Roundtable on Clinical Research. The consultations are very much in the DBT's agenda.
The Department has also announced its plans to harmonise and streamline the regulatory issues for important and export of biological materials. It has proposed a long list of adaptable measures to enhance the scope of CR in India. This include a review in the eligibility of virtual export of R&D services through contract research for fiscal incentives, addressing the operational deficiencies through stakeholder consultations for conducting clinical trials, developing a Good Clinical Trial Practice Manual taking into account international guidelines for wider dissemination etc.
The department has also proposed a collaborative initiative with ICMR to promote, train and support clinical trial investigators. Strengthening of clinical trial capacity in medical schools and hospitals and creation of centres of excellence is another possibility pointed out by DBT.
The cost of launching a new drug into the market is estimated between $300-500 million of which the cost split between Research and Development is 25% : 75% which would translate to an approximate cost of US$200-400 million for patient clinical studies and trials which form the main components of drug development. DBT feels India has the potential of being a key player in this segment if it develops the infrastructure required to identify, document and monitor patients under clinical trials. Measures are needed to ensure patent safety and compliance with ethical and regulatory requirements. The quality of trials should be such that data generated are accepted globally. Clarity in rules is required related to biotech drugs developed by Indian companies abroad, drugs discovered abroad and licensed to an Indian company, and drugs discovered by an Indian subsidiary of foreign company, DBT has pointed out.
DBT also foresees an exciting opportunity of conducting longitudinal studies in disease segments for prospecting new biomarkers and novel pharmacogenomic information both yielding high value Intellectual Property in the country.