4 days ago
India’s New Digital Drug System Attracts Twelve Bids
India’s drug regulator is choosing a company to build a new digital system.
Twelve companies have submitted bids for the project.
The system may begin operating within about a month.
It is intended to use artificial intelligence and data analysis to make drug regulation more efficient.
It may also make applications and other processes easier for pharmaceutical companies and researchers.
The regulator is seeking approval for 1,500 new scientific positions.
These workers would help review medicines, inspections and audits.
India is also considering allowing some first-in-human studies for products developed abroad.
Officials said more global clinical trials are being conducted in India because companies have greater confidence in the country’s research standards.
Twelve companies have bid to build CDSCO’s Digital Drug Regulatory System.
Technical presentations are complete, with financial bids expected to open within 7–10 days.
The platform is expected to launch within a month and use artificial intelligence and data analytics.
CDSCO plans to create an internal scientific cadre, with 1,500 positions agreed to in principle.
India is considering clinical-trial reforms, including first-in-human studies for some overseas-developed assets.
- Who
- The Central Drugs Standard Control Organisation, led by Drugs Controller General of India Dr Rajeev Raghuvanshi, and twelve bidding companies.
- What
- CDSCO is developing a Digital Drug Regulatory System and considering wider regulatory and clinical-trial reforms.
- Where
- India.
- When
- The announcement was made on September 18, 2026; the platform is expected within a month, and financial bids within 7–10 days.
- Why
- To expand digitisation, use artificial intelligence and data analytics, simplify regulatory processes, and strengthen scientific review capacity.
Key facts
- Bidders
- Twelve companies submitted bids for the Digital Drug Regulatory System.
- Expected rollout
- The platform is expected to be rolled out within the next month.
- Financial bids
- Financial bids are expected to be opened within 7–10 days of the announcement.
- Current digitisation
- More than 99% of India’s regulatory processes are already completely digital, according to Raghuvanshi.
- Planned scientific positions
- CDSCO has received in-principle agreement for 1,500 new positions.
- Clinical trials
- Global clinical trials in India are expected to reach about 160 this year, up from roughly 120–130 previously.
- Research permissions
- Prior regulatory permission has been removed for most research activities, except certain critical areas.
Quotes
Rajeev Raghuvanshi
Dr Rajeev Raghuvanshi is the Drugs Controller General of India.
“Unless we create an internal scientific cadre where more than 90-95 per cent of SEC work is done internally, these gaps are very difficult to fill with the current SEC system”
thehindubusinessline.com
“You can design your protocol, and you do your study and use it as you want to use it”
thehindubusinessline.com
Sources
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