1. Pink Sheet
  2. >>Pathways & Standards

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

 
• By Anju Ghangurde

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”.

Addressing the annual summit of the Organisation of Pharmaceutical Producers of India (OPPI), Dr Rajeev Raghuvanshi, Drugs Controller General of...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Pathways & Standards

Prasad’s Return Shelves Center Consolidation, But Maybe An Opening For OCE 2.0?

 
• By Kate Rawson

Vinay Prasad’s exit from the US FDA reignited conversations about integrating its drugs and biologics centers under George Tidmarsh. Those plans appear to be shelved, but the leadership transition could be an opportunity to fully realize the vision for the Oncology Center of Excellence.

EMA Revives Face-To-Face Oral Explanations In Response To Industry Feedback

 
• By Vibha Sharma

The European Medicines Agency is bringing back in-person oral explanation meetings with drug sponsors on a pilot basis, following industry feedback that direct engagement with its scientific committees is highly valued.

New EU Filings

 
• By Neena Brizmohun

Ensitrelvir, Shionogi's treatment for COVID-19, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.

With Thyroid Petition Win, AbbVie Snares Itself; US FDA Sets Up Another Compounding Fight

 
• By Manas Mishra

AbbVie didn’t get everything it sought from a citizen petition but may still have the upper hand over smaller rivals after FDA gives makers of animal-derived thyroid medications a year to seek approval. If the agency removes compounded products, it could face more pricing pushback.

More from Compliance

ICH Proposes Global Framework For Managing Leachables In Pharma Products

 
• By Vibha Sharma

The International Council for Harmonisation has developed a holistic approach for the assessment and control of leachable impurities, supporting drug product development, registration and ongoing quality management throughout the product lifecycle.

50% Levy On India And Brazil, US Tariffs Leave Global Trade, Forecasts In Disarray

 
• By Vibha Ravi

50% tariffs on US imports from India, a range on others, an uncertain outcome of Section 232 investigations of pharma and talk of BRICS tariffs are making the forecasting environment for the pharma industry extremely difficult, the Pink Sheet finds in this infographic analysis.

Manufacturers Can Keep Their Shoes On: FDA PreCheck To Streamline US Facility Applications

 
• By Derrick Gingery

The program would allow early interactions with FDA staff to speed construction and approval of pharmaceutical manufacturing facilities in the US, but will staff be available?