The record
Written from the 1 report below. Nothing here is unsourced.
- Twelve companies have bid to build a new Digital Drug Regulatory System for the Central Drugs Standard Control Organisation (CDSCO).
- Financial bids are expected to be opened within the next 7-10 days, and the platform is slated for rollout within a month.
- The system will use artificial intelligence and data analytics to decide where regulatory intervention is needed and to simplify processes for the industry.
- CDSCO is also working on an internal scientific cadre of 1,500 new positions, recruitment for which will begin once approval is cleared.
- The changes matter because they aim to digitise drug regulation further, speed up approvals, and improve ease of doing business for pharmaceutical companies.
What to watch next
- Opening of financial bids within the next 7-10 days and the announcement of the winning company.
- Rollout of the Digital Drug Regulatory System expected within the next month.
- Approval of the 1,500 new scientific positions and the start of recruitment.
Who said what2
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Rajeev Raghuvanshi
Drugs Controller General of India
2 quotes · 1 outlet
“This is a very big and ambitious project for the regulatory system”
In the article
…platform is expected to be rolled out within the next month and will use artificial intelligence, data analytics and simplified processes to transform drug regulation and ease of doing business in the country. “ This is a very big and ambitious project for the regulatory system ,” Raghuvanshi said at the 8th CII Pharma & Lifesciences Summit, adding that it would change the “entire regulatory landscape” of the country in terms of digitisation and ease of doing business. Smart Compliance The new…
“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”
In the article
…the proposal is cleared. The additional workforce will help CDSCO build expertise for reviewing new drug applications, audits and inspections and address gaps in the existing Subject Expert Committee (SEC) system. “ 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 ,” he said. Raghuvanshi also said reforms to the Review Committee on Genetic Manipulation (RCGM) were progressing, describing them as a major demand from industry. A solution was expected soon, he said, along with…
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Named India · Central Drugs Standard Control Organisation · Confederation of Indian Industry · Rajeev Raghuvanshi
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