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 India’s apex drug regulator, the Central Drugs Standard Control Organisation (CDSCO), is set to significantly expand its drug regulatory audit capacity by formally engaging competent notified bodies certified by the Quality Council of India (QCI), informed Drugs Controller General of India (DCGI) Dr. Rajeev Singh Raghuvanshi.
Dr. Raghuvanshi further said that the move has received agreement from the government in principle and discussions are in the final stages. Discussions with the QCI have already commenced, and CDSCO is in the final stages of formalising the engagement framework. Once implemented, the reform is expected to significantly enhance audit coverage, improve compliance monitoring, and strengthen India’s overall drug regulatory architecture.
“We have agreed with the government, and in principle approval is there for identifying competent notified bodies in our audit system. Until now, audits were being conducted by drug inspectors of the CDSCO or the state drug regulatory authorities. Now, looking at capacity and manpower gaps, we have decided to involve competent notified bodies certified by QCI for different kinds of audits,” Dr Raghuvanshi added.
Dr Raghuvanshi noted that in certain categories of drugs, regulatory audits have not been conducted at all due to manpower shortages and structural constraints. “In some categories of drugs, our regulatory audit system has not been able to carry out audits. This engagement will help take care of all aspects of the drug regulatory system audits,” he said.
The proposed framework aims to bridge these gaps by onboarding competent third-party notified bodies accredited by QCI, thereby expanding audit bandwidth and improving oversight standards across drug manufacturing segments.
The move is aligned with global best practices, particularly the European system under the European Medicines Agency (EMA) regulatory ecosystem, where notified bodies play a key role in evaluating and approving medical devices based on CE certification norms.
Under the European model, notified bodies assess conformity and grant certifications before products enter the market. India now seeks to adapt this mechanism in a calibrated manner for strengthening its drug audit system.
Beyond inspections, the DCGI also flagged structural gaps in CDSCO’s internal scientific review framework. He highlighted the absence of a dedicated in-house scientific cadre for reviewing clinical protocols, bioequivalence protocols, and other clinical aspects of drug applications.
“There is no internal scientific cadre for review of clinical protocols or bio-protocols. We are dependent on external subject expert committees. There is a need for significant improvement in the institutional memory of CDSCO,” Dr Raghuvanshi stated.
Currently, CDSCO relies heavily on external subject expert committees for technical and clinical evaluations, which can affect continuity and institutional knowledge building. To address these systemic gaps, CDSCO is preparing to seek government approval next month for a major manpower expansion.
Dr. Raghuvanshi further revealed that the organisation plans to recruit approximately 1,500 personnel to strengthen internal scientific review capacity, particularly for clinical site evaluations and regulatory approvals. The proposed expansion is aimed at making India’s regulatory review and approval system more robust and aligned with leading global agencies such as the United States Food and Drug Administration (FDA).
“The objective is to make our review and approval systems more robust, on par with other global regulatory bodies like the US FDA and even better,” he said.
The initiative comes at a time when India is seeking to reinforce global confidence in its pharmaceutical regulatory systems while addressing domestic capacity constraints through structural reforms.
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