The Task Force on 'Enabling the private sector to lead the growth of pharmaceutical sector', constituted by the department of pharmaceuticals (DoP) in November last year to provide thrust to the pharma sector in the country, has recommended simplification of approval process for clinical trials in the country.

It recommended to create simplified and streamlined process along with well defined timelines for approvals of clinical trials. Currently, the industry is faced with a 3-tier structure for permitting clinical trial of a new drug with the chain of Expert Committee, Technical Committee and Apex Committee having overlapping mandates, the Task Force noted in its report while recommending simplification of the approval process for clinical trials.

In yet another major recommendation, the Task Force asked the government to take measure for digitalisation of clinical trial, licensing and quality control processes. The entire clinical trial, licensing and quality control processes etc. may be computerised and made online to speed up the process and increase transparency. In addition, the ministry should also create a single window medicine monitoring IT system to link the headquarters, state offices and government hospitals to seamlessly communicate drug related information, it said.

The Task Force, headed by secretary, DoP, has asked the government to rationalise environmental clearances. The process of environmental clearance may be rationalised and made time-bound e.g. a company already having Pollution Control Board clearance need not apply again in case of change in product mix as the total effluent discharge remains the same. In this connection it may be noted that the pharmaceutical industry is innovation driven and better processes or substitutes are employed to increase the competitiveness, it said.

Asking the government to provide flexibility to the pharmaceutical companies to file for test licensing, the task force recommended that companies should be granted flexibility to file its application from central office or the zonal office. Moreover, the infrastructure capacity at the zonal offices need to be strengthened to help companies applying for license and getting the treasury challan verified by the Inspector before filing.

The Task Force also recommended for parallel processing of regulatory clearances for imported drugs. The time taken for obtaining regulatory clearances for launch of a new imported drug may be reduced from current duration of 3 to 4 years; if the clearances like marketing approvals, site registration etc. can be processed in parallel, instead of sequential processing being done presently, it said.