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CDSCO seeks urgent industry inputs on regulatory challenges and innovation in pharma

Shardul Nautiyal, Mumbai
Thursday, January 23, 2025, 08:00 Hrs  [IST]

The Central Drugs Standard Control Organization (CDSCO) has issued an urgent call for inputs from pharmaceutical industry stakeholders to identify current challenges within the existing regulatory framework. This call is also to explore opportunities for streamlining processes without compromising the quality of medical products.

Pharmaceutical companies, research organizations, and healthcare professionals are encouraged to provide insights on the regulatory hurdles they face in areas such as drug approvals, compliance procedures, and market entry barriers. The objective is to refine regulatory processes to enhance efficiency while maintaining stringent safety and quality standards.

Industry representatives have long highlighted concerns regarding procedural delays, redundant compliance requirements, and regulatory bottlenecks that hinder timely patient access to essential medicines. CDSCO’s initiative seeks to address these issues and create a more dynamic and responsive regulatory environment.

A key focus of the consultation is on fostering homegrown innovation, particularly in cutting-edge fields such as gene and cellular therapy, stem cell research, and personalized medicine. With India emerging as a global hub for pharmaceutical manufacturing, CDSCO aims to strengthen support mechanisms for local innovators and research institutions.

Stakeholders are invited to share recommendations on policy enhancements, regulatory adaptations, and funding initiatives that could accelerate the development and commercialization of advanced medical technologies. The regulator is particularly interested in proposals that balance innovation with patient safety and ethical considerations.

CDSCO has urged industry members to submit their inputs at the earliest, emphasizing the importance of collective efforts in shaping a more robust and innovation-friendly regulatory landscape. The feedback received will inform future policy decisions and contribute to India’s positioning as a leader in pharmaceutical and biotechnological advancements.

For further details and submission guidelines, industry stakeholders are encouraged to reach out to CDSCO through its official communication channels.

 

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Sandip Todmal Jan 25, 2025 9:41 AM
Cost for quality is high.
Should work with Industry experts for right quality at right cost.
ADARSH KUMAR TIWARI Jan 24, 2025 6:38 PM
I am M Pharm passout 2022 in RKDF school of science
Need job
Shaik Imran Basha Jan 24, 2025 3:27 PM
Iam m Pharmacy student from Andhra University .I have an idea for the maintaining the quality standards for drugs as of now we are seeing many of the recall of medicines even after the quality check ...soo my concern is that we must try to ad an AI check after the completion of qc checks to overcome the issues of these labelling recalls ..etc
Harshwardhan Thakur Jan 24, 2025 12:30 PM
Need Job
Sarila Jan 24, 2025 11:56 AM
Great work it's mandatory
Dr D Sreedhar Jan 24, 2025 11:20 AM
The Central Drugs Standard Control Organization’s initiative to solicit input from pharmaceutical industry stakeholders reflects a progressive step toward improving India’s regulatory landscape for medical products. By directly engaging with industry representatives, researchers, and healthcare professionals, the CDSCO demonstrates a commendable commitment to addressing procedural inefficiencies and fostering an ecosystem conducive to innovation.
The focus on enhancing efficiency without compromising quality aligns with global best practices in regulatory science. Procedural delays and redundant compliance requirements are well-documented impediments to timely drug approvals and market accessibility. Addressing these bottlenecks is critical, not only for ensuring swift patient access to life-saving medications but also for maintaining the competitiveness of India’s pharmaceutical sector in a globalized economy.
Overall, CDSCO’s initiative represents a strategic opportunity to harmon
Dinesh Kumar Anchal Jan 24, 2025 5:25 AM
The approval procedures must be practical rather theoretical. In clean room area checks are placed but rarely comply. Still drugs are approved even in micro. Fungus limits are placed but treated as Total viable counts with micro testing. Separate to be placed as it's not classified in ICH or Micro guidelines. Website not applicable so
Deepak Kajla Jan 23, 2025 8:38 PM
Cutting Edge Technologies, Drug Repurposing, Utilization of AI tools, robotic Technologies, 3d printing, Medical Devices and Biosensing Technologies may produce a big hurdle in upcoming time. Specially when we will go for their method developments, standardization, and Intellectual Property Rghts Registration as per IPR sections. Another big challenge will produce in the regulatory section to fulfill the main aspect as demanded....mainly..
All preformulation parameters, Compatibility parameters, R&D, Overall Validation, Homogeneity, content Uniformity, Assay, QA/QC, In-Process Validation, Production, Finished Product Validation, Stability, Clinical Phases & solicited and unsolicited ADR reporting to aware FDA to prohibit the hazardous drug from India and to enhance Quality and Safety of products to safeguard the population of India.

A high need to aware the Doctor and Pharmacy for ...
How much, how to take, when to take, how to apply, how to calculate the dose will assure whole In
 
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