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India’s global pharma status hinges on regulatory strengthening: Dr Chandrashekar Ranga
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Nandita Vijayasimha, Bengaluru
July 15 , 2025
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Strengthening India’s drug regulatory system is critical to ensure safety, efficacy, and quality of medicines both for domestic use and for export. India is a leading pharmaceuticals producer globally. However, repeated concerns about quality control, regulatory capacity, and enforcement have highlighted the need for systemic reforms, said Dr. Chandrashekar Ranga, Joint Drugs Controller India, CDSCO.
Current key challenges that emerge in the country to strengthen the drug regulatory system are shared responsibilities, capacity constraints, divergence with global practices and lag in harmonization, he added.
Speaking at the recently concluded 3rd annual congress of the Drugs Control Officers (I) Welfare Association, Dr Ranga said as per the WHO Global Benchmarking Tool (GBT), which assesses national regulatory systems for medical products, Licensing Establishments (LI) is a key area within this tool. Here, LI06 mechanism exists to promote transparency, accountability and communication in licensing activities which raises confidence in the regulatory system.
An updated database of all licensing applications, along with the regulatory decision for each, is regularly published and publicly available. Also, a complete list of licensed facilities throughout the supply chain, along with the regulatory decision for each application on whether the license was granted or not is in place, he said.
Delving on the Good Regulation Practices (GRP), Dr Ranga said India needs to develop regulations that are flexible. It needs to be consistent in guidance and decision-making, efficient in records management, maintain performance and transparency and be reachable and reach out to stakeholders.
While developing regulations that are flexible, India should strike a balance between protection of the public and enabling R&D, allow flexibility for regulating in the current and future environment.
Besides, there should be consistency in guidance and decision-making, adopt international guidelines when appropriate and develop SOPs (standard operating procedures) like good review practices, implement guidelines to address regional issues. It is also of critical importance to be reachable and reach out to stakeholders, he said.
On a similar mode India when regulations are framed, needs to provide opportunities for dialogue with sponsors and stakeholders formally and informally like for instance call for pre-clinical trial meetings and tele conferencing, he said.
The way forward is capacity building and training to address regulatory science and boost quality surveillance. This would bring in public trust and transparency.
With technology entering, US FDA released its first draft guidance in January 2025 on how artificial intelligence (AI) can be used to support regulatory decision-making for drugs and biologics. It is a landmark move that sets the stage for integrating AI into the drug development lifecycle with credibility and transparency, he noted.
On whether it is a threat to the inspector in future, Dr Ranga said, “Investigating drug quality failures demands a blend of technical expertise, analytical thinking, and regulatory awareness. It is here for Root Cause Analysis (RCA) using essential skills where tools like 5 Whys, Fishbone diagrams, Fault Tree Analysis, and FMEA need to be deployed to trace failures to their origin. There is need for process mapping where workflows need to identify breakdowns in manufacturing, testing, or distribution. Deviation Classification models can distinguish between critical, major, and minor deviations to prioritize investigations. With data interpretation, analysis of batch records, trend data, equipment logs, and analytical results to spot anomalies need to be focussed on.”
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TOPICS
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