Versuchen GOLD - Frei
Govt Unveils Rules on How Panels Should Vet New Drugs
Mint New Delhi
|August 02, 2025
The move aims to fix concerns about opaque approvals that have delayed key drug launches
India has issued its first formal playbook for how expert panels should vet new drugs, biologics and medical devices—a move aimed at fixing chronic concerns about inconsistent and opaque approvals that have delayed critical drug launches and eroded trust in the regulatory system.
The guidelines, issued by the Central Drugs Standard Control Organization (CDSCO), represent a major overhaul of India's drug approval process and aim to make regulatory decisions faster, more predictable and transparent, according to two government officials and documents reviewed by Mint.
The guidelines standardize how Subject Expert Committees (SECs) are formed, members are selected and how they must evaluate applications, including the scientific benchmarks and disclosure norms they must follow.
The SECs advise the Drugs Controller General of India (DCGI) on whether to clear new drugs, and their decisions have long shaped the trajectory of India's pharmaceutical industry.
The CDSCO finalized the norms about two weeks ago and circulated them to SEC members for immediate implementation, the officials said, asking not to be named.
The overhaul follows recommendations from the World Health Organization (WHO), which last year conducted a regulatory review of CDSCO and the office of the DCGI, who heads the organization.
Diese Geschichte stammt aus der August 02, 2025-Ausgabe von Mint New Delhi.
Abonnieren Sie Magzter GOLD, um auf Tausende kuratierter Premium-Geschichten und über 9.000 Zeitschriften und Zeitungen zuzugreifen.
Sie sind bereits Abonnent? Anmelden
WEITERE GESCHICHTEN VON Mint New Delhi
Mint New Delhi
Softbank’s 40% fall from peak shows worry on OpenAI bet
Growing unease over frothy artificial intelligence (AI) valuations is weighing on shares of SoftBank Group Corp.
2 mins
November 27, 2025
Mint New Delhi
PepsiCo taps gourmet taste buds with Red Rock Deli’s India debut
Snack and cola maker PepsiCo is finally giving gourmet a chance with the launch of Red Rock Deli chips, priced ₹60 and ₹125 a pack, in a shift from its years-long focus on mass-market Lay's that starts as low as ₹5.
2 mins
November 27, 2025
Mint New Delhi
Fintechs turn fund magnets with cross-border licensing
Funders see growth prospects in central bank's payment aggregator-cross border licensing
3 mins
November 27, 2025
Mint New Delhi
'First-gen founders take bigger investment risks'
India’s markets are minting a new class of first-generation millionaires: entrepreneurs who’ve scaled ideas into Initial public offerings (IPOs) and unlocked unprecedented personal wealth.
2 mins
November 27, 2025
Mint New Delhi
Fundamentum readies four portfolio startups for IPOs
Nandan Nilekani-led venture capital firm Fundamentum is lining up at least four companies in its portfolio for a public listing over the next 12-24 months, co-founder and partner Ashish Kumar said.
2 mins
November 27, 2025
Mint New Delhi
Ukrainians resist pressure from Russia—and Trump
Battered by nearly 4 years of war, Ukrainians don’t want to make big concessions to Moscow
4 mins
November 27, 2025
Mint New Delhi
These firms will sell shovels during semaglutide gold rush
Weight-loss drug semaglutide, also used to treat type-2 diabetes, will face its next big turning point in early 2026, when patents held by Novo Nordisk expire in India.
2 mins
November 27, 2025
Mint New Delhi
IL&FS group repays ₹48,463 cr loan
Debt-ridden IL&FS group has repaid ₹48,463 crore to its creditors as of September 2025, out of the total ₹61,000 crore debt resolution target, as per the latest status report filed before insolvency appellate tribunal NCLAT.
1 min
November 27, 2025
Mint New Delhi
From playlists to pay-lists— streaming platforms go flexi
Audio streaming platforms reshape their business models to turn free listeners into paying subscribers, tiered pricing and micro-transactions have become key to their survival in a market where users are reluctant to pay for content.
2 mins
November 27, 2025
Mint New Delhi
AI trade splinters as Google challenges Nvidia’s dominance
Investors are sending two leaders of the AI trade in opposite directions.
3 mins
November 27, 2025
Listen
Translate
Change font size

