India Regulatory Reform: ‘Redeliberation’ At SECs Tightened, ‘Unnecessary Load’ Reduced

India continues to reform biopharma regulatory processes and widen digitization efforts. The regulator will curb "re-deliberations" at subject expert committee meetings unless applicants furnish new data.

L to R: Anil Matai, Director General OPPI; Vinod Kotwal Member Secretary, NPPA; Bhushan Akshikar, MD, GSK Pharmaceuticals; Anupriya Singh Patel, Union Minister Of State For Health And Family Welfare, Dr Arunish Chawla, Secretary, Department of Pharmaceuticals, Ministry of Chemicals & Fertilizers; DCGI Dr Rajeev Raghuvanshi; and Amitabh Dube, country president and MD, Novartis in India.

India’s drugs regulator continues to implement reforms to improve systems and procedures as part of its thrust towards simplifying regulation, while ensuring execution is “intense”.

More from Pathways & Standards

‘Pipeline In A Pill’ Or Pipe Dream? US FDA’s April Goal Dates Test Expansion Strategies

 

Sanofi’s Dupixent, Amgen’s Uplizna, and Bristol’s Opdivo seek new indications, while J&J hopes to start a franchise with nipocalimab and Stealth’s day of reckoning approaches.

US FDA Staffing Uncertainty Could Impact Upcoming User Fee Negotiations

 

FDA staffing cuts are making negotiation preparations more difficult, but also could mean the result is a smaller user fee renewal package.

EMA Considers Whether Intrathecal Zolgensma Deserves Fast Tracking

 

Novartis is planning to file EU and US marketing applications for an intrathecal formulation of its spinal muscular atrophy gene therapy, Zolgensma, in H1 2025.

Surrogate Endpoint ‘Reasonably Likely’ Decision Process An ‘Uncertain Standard,’ Industry Says

 
• By 

The FDA’s accelerated approval draft guidance has left stakeholders seeking clarification of the process for determining a surrogate marker or intermediate clinical endpoint is reasonably likely to confirm clinical benefit.

More from Compliance

How To Leverage US FDA’s ‘Consistent With Labeling’ Guidance In DTC Ads

 
• By 

Sponsors should review longstanding agency concepts on consumer-friendly language and claims limitations, along with Office of Prescription Drug Promotion research and enforcement, when applying the 2018 CFL guidance to direct-to-consumer advertising, Sidley Austin’s Cope says.

US FDA May Lose Some Autonomy Under Health Department’s General Counsel Reorg

 

Health and Human Services Secretary Robert F. Kennedy Jr. is moving FDA Chief Counsel Robert Foster to a new senior position as Chief Counsel for Food, Research, and Drugs at HHS. Hilary Perkins will become FDA chief counsel.

EU’s Critical Medicines Act: A Major Milestone Or Too Weak?

 

Newly proposed legislation for bolstering the EU’s drug manufacturing capacity and reducing its overreliance on foreign manufacturers includes a number of measures, such a requirement for EU countries to prioritize the security of supply over price when procuring drugs.