The Union Minister of Health and Family Welfare have proposed a regulatory pathway for pharmaceutical companies conducting clinical trials and planning to launch products in the country.
The ministry has proposed ‘pre-submission meetings’ to enable technical deliberations between the drug regulator and stakeholders to address concerns even before companies make formal application seeking product approvals or permission for clinical trials.
“Stakeholders feel that there should be a window for technical deliberations with the regulator and subject experts before submission of formal application. This would mean there is a discussion over the regulatory pathway and companies addressing concerns or making applications in a more systematic way fulfilling the requirements,” an official said. He added that the exercise would save time and resources for both – the industry as well as the regulator which has to scrutinize several applications in detail.
The idea is to facilitate speedy approvals, while bringing in transparency, accountability and predictability, a latest notice by the Drugs Controller General of India (DCGI), proposing the move, said. DCGI, operating under the health ministry, is the drug quality regulator with a mandate to approve new drugs, clinical trials and medical devices. It also monitors the quality and efficacy of pharmaceutical products sold in the market.
The drug manufacturing industry, one of the top contributors to the country’s exports, is a major investment destination and a focus area for the Modi government’s ‘Make in India’ campaign.
However, in the past few years, the sector witnessed a significant slowdown in product approvals, clinical trials approval along with almost a year long ban on foreign investment approvals in the absence of a clear FDI policy for the sector.