In the fast-evolving landscape of drug regulation, the adoption of new online systems is emerging as a pathway to efficient and effective processing by regulatory authorities.
This shift comes in response to a circular from the deputy drugs controller at India’s office, advocating the transition from physical files to e-mode for processing offline applications—a move in sync with the Digital India programme of the central government.
1. Embracing Digital Transformation
The digital era beckons for the Indian drugs regulatory system, a sentiment echoed by Dr. BR Jagashetty, former National Adviser (Drugs Control) to the Union health ministry.
With the proven capability and expertise of the Indian pharmaceutical industry, the adoption of online platforms signifies a significant leap forward.
1.1 Gaining Global Traction
Dr. Jagashetty emphasizes that this transition positions the Indian drug regulatory system as a formidable player in the global market.
The move towards digital processing aligns with the growing recognition of the prowess of the Indian pharmaceutical industry.
2. Dispelling Unnecessary Practices
However, amidst the progressive shift, concerns arise regarding the mention of soft copy submissions via pen drives.
Dr. Jagashetty contends that such practices are unwarranted, given the availability of more viable alternatives.
2.1 The Rise of Google Drive
Highlighting examples like the Seva Sindhu citizen service portal and CDSCO’s Sugam portal, Dr. Jagashetty suggests that Google Drive emerges as a more practical and efficient alternative.
Submitting scanned copies in PDF format via Google Drive proves to be a streamlined and accessible method.
3. Streamlining Government Operations
Taking a cue from the Karnataka government, which employs Letter Movement Files (LMF) and File Movement Services (FMS), the regulatory process gains transparency and accountability.
The digital submission of annual personal confidence reports further solidifies the efficiency of the online system.
3.1 Karnataka’s Pioneering Digital Processes
Karnataka has set an example with a comprehensive digital process for all types of applications, emphasizing the viability and efficiency of such systems.
4. Ensuring Data Security
Dr. Jagashetty reassures that in terms of data security, existing legislation like the Information Technology Act and CDSCO’s expertise in data security ensure the protection of crucial drug patent information.
5. International Collaboration for Market Access
Kaushik Desai, a pharma consultant, applauds the active engagement of Indian regulatory authorities with international bodies.
The alignment of regulatory practices and mutual recognition of standards through e-file processing enhances market access for Indian pharmaceutical products globally.
5.1 Accelerating Approval Processes
Desai emphasizes that this initiative by CDSCO aligns India with global best regulatory practices, expediting the document review and approval process, a sentiment echoed by efficient states like Gujarat.
6. The Imperative of Cybersecurity
While lauding the move, Desai issues a word of caution.
Establishing secure digitized systems and robust cybersecurity measures with traceability becomes paramount, particularly to protect proprietary and sensitive data.
Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.
Q1: How does the online system benefit the Indian pharmaceutical industry globally? A1: The system enhances efficiency, aligns with global practices, and facilitates smoother market access.
Q2: Are pen drives still a viable option for submission? A2: According to experts, pen drives are deemed unnecessary; Google Drive emerges as a more practical alternative.
Q3: What measures are in place to ensure data security? A3: Stringent cybersecurity measures, guided by existing legislation, protect sensitive drug patent information.
Q4: How do states like Gujarat contribute to the efficiency of the online system? A4: States like Gujarat have implemented comprehensive digital processes, expediting document review and approval.
Q5: What caution should be exercised in implementing secure digitized systems? A5: Establishing robust cybersecurity measures with traceability is imperative, ensuring the protection of proprietary and sensitive data.
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