Last Updated on November 28, 2021 by The Health Master
The pharmaceutical industry has appealed to the government to introduce a single window clearance system at the Drugs Controller General of India (DCGI) office in CDSCO to facilitate innovation of novel drugs, vaccines, and biologics.
Currently, key decision-making powers on various issues such as patents, licensing, and pricing are with different departments.
The issue of patents is handled by the Department of Industrial Policy and Promotion, drug licence is issued by DCGI under health ministry and pricing is regulated by National Pharmaceutical Pricing Authority (NPPA), under Department of Pharmaceuticals.
Dr Sanjay Singh, chief executive officer of Gennova Biopharmaceuticals Ltd, “Innovation is very cost intensive, time-consuming, and riskier.” We have to innovate.
There should be a single window clearance system at DCGI office so that drug makers engaged in developing innovative products should not run from pillar to post seeking various regulatory clearances. We have been demanding this for over a decade.”
Earlier, task force set up by the government had also recommended for setting up of a high-level coordination committee under Secretary, Pharmaceuticals which will comprise representatives from Department of Industrial Policy and Promotion, Commerce, Science and Technology, Biotechnology, Environment and Health and Family Welfare to facilitate single window clearance system in pharmaceutical sector.
Dr. Singh also stressed the need for a continuous dialogue between policymakers, industry, regulatory bodies and researchers to facilitate innovation of new drugs, vaccines.
He opined that the dialogue should not evolve based on the need, as it happened during the C-19 pandemic, where the regulatory body and industry worked together to come up with innovative products to address patient needs.
“Regulations should be strict and logical. Guidelines are just for reference but regulatory decisions should be based on mutual understanding as there is human safety involved in it,” he said.
Currently, raw materials required for vaccine production need to be imported which is very costly. Backward integration is needed to address this. Policymakers need to see various aspects of backward integration through a different lens, he added.
He further emphasized the need to prioritize the diseases for which novel drug discovery needs to be taken up in line with C-19.
Gennova Biopharmaceuticals is working on the nation’s first mRNA-based C-19 vaccine. Gennova, which completed phase I and phase II studies of the vaccine candidate, is entering a phase III clinical trial which will evaluate the safety, tolerability, and immunogenicity of the candidate HGCO19 (C-19 vaccine) in healthy subjects.
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