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CDSCO ushers in transparency, global alignment in Indian drug regulation system with 97% digitization: DCGI
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Shardul Nautiyal, Mumbai
September 09 , 2025
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Drugs Controller General of India (DCGI) Dr. Rajeev Singh Raghuvanshi has said that 97% of operations at the Central Drugs Standard Control Organisation (CDSCO) are now digital, helping the apex regulator to eliminate 25% inefficiencies across the board.
Speaking to Pharmabiz on the sidelines of the 11th International Exhibition on Pharmaceuticals and Healthcare (iPHEX 2025) in New Delhi, held from September 4 to 6, 2025, Dr Raghuvanshi said the CDSCO has made sweeping advancements in digital integration. With 97% of its functions digitised, the regulatory body has cut down inefficiencies by 25% for India's emergence as a future-ready pharmaceutical hub.
An important feature of this digital transformation is the individual dashboard system for CDSCO team members, enabling real-time tracking of pending files. This has not only infused transparency but also ensured faster processing and accountability across the regulatory chain.
In a move set to benefit exporters and enhance drug control, export NOC issuance now takes less than seven days due to digitisation. This reform is particularly crucial in controlling the outflow of unapproved drugs, thereby reinforcing patient and public safety both within India and globally.
"The speed and transparency with which we now operate make it easier to integrate India’s expectations into the global pharmaceutical framework”, Dr. Raghuvanshi said.
Dr. Raghuvanshi also emphasized that India’s drug regulations have been streamlined to reduce bureaucratic burden. This approach has freed up resources for value-added work such as innovation oversight, global harmonisation, and public safety, without compromising regulatory rigour.
"By simplifying regulations operationally, we are paving the way to revisit and revise them to be more flexible, aligned with global healthcare needs," he noted.
The revised Schedule M notification is encouraging Indian pharma companies to adopt higher WHO-GMP standards. This has enhanced India's competitive edge in regulated markets and expanded its presence in low and middle income countries (LMICs), which receive over 90% of India's quality-assured medicines.
In a bid to align with global best practices, India is now progressing towards Pharmaceutical Inspection Co-operation Scheme (PIC/S) compliance. This transition mandates that state regulators upgrade their systems to meet PIC/S-level standards.
“To drive this, CDSCO has launched a State Regulatory Index, a ranking system that scores states on regulatory performance. This initiative is aimed at ensuring healthy competition among states and pushing for regulatory compliance in accordance to PIC/S, harmonisation and capacity building among state regulators,” Dr. Raghuvanshi explained.
“India is also transitioning from a generics-led industry to a more innovation-focused ecosystem, embracing biosimilar development. With exports reaching over 200 countries, India’s robust regulatory system is drawing recognition globally," he added.
“International organisations are acknowledging the credibility of India’s regulatory infrastructure. To date, 17 countries have officially recognised the Indian Pharmacopoeia (IP) and over 20 nations have signed MoUs with CDSCO for regulatory knowledge exchange,” Dr Raghuvanshi explained.
“India continues to contribute to the global drug safety ecosystem via the Pharmacovigilance Programme of India (PvPI). The Indian Pharmacopoeia Commission (IPC) actively reports adverse drug reactions (ADRs) to the Uppsala Monitoring Centre (UMC), a WHO Collaborating Centre. This engagement not only enhances global ADR tracking but also empowers Indian regulators with vital insights for evidence-based decision-making and drug safety enhancement,” he concluded.
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