CDSCO’s new online submission system a game-changer: Experts
Regulatory experts and industry captains are of the view that adoption of new online submission systems will be a pathway to efficient and effective processing by the regulatory authorities. This follows after a circular from the deputy drugs controller India’s office to switch over from physical files to e:mode for processing all offline applications. The move is in sync with the Digital India programme of the central government.
Online submission platforms offer numerous benefits compared to traditional methods, such as increased accessibility, improved organization capability, faster turnaround, transparency and accountability.
According to Dr BR Jagashetty, former National Adviser (Drugs Control) to Union health ministry and former Karnataka State Drugs Controller, this is the best that could happen to the Indian drugs regulatory system which is gaining traction in the global market with the proven capability and expertise of the Indian pharmaceutical industry. It takes the Indian drug regulatory system head-on into the digital era.
However the mention of soft copy in pen drive is unwarranted. There is actually no need for a pen drive submission. For instance, the Seva Sindhu which is a citizen service portal/facility of the Karnataka government, provides all government related services and other information in one place. Similarly, CDSCO too has the Sugam portal where for medical devices, it is completely e:service mode. Now we see that pen drive option makes no sense but Google drive is a more viable and best alternative, to submit scanned copies preferably in less than 20 MB in PDF format, he added.
Further, Karnataka government offices have a LMF (letter movement file) and FMS (file movement service), which indicates the time schedule of each officer’s clearance cycle making him answerable to the delay if it is kept beyond the stipulated duration. Even the annual personal confidence reports of officers of the drugs control department are also submitted online, proving to be a full proof, he said.
Therefore, submissions to the CDSCO applications online is the most practical and sustainable option. Now in terms of data security, the government already has a strong Information Technology Act and CDSCO is well versed in data security as drug patent is intrinsic to regulatory approvals, Dr Jagashetty said.
Chiming in on a similar note was Kaushik Desai, a pharma consultant, who said that the Indian regulatory authorities have been actively engaging with international regulatory bodies to align regulatory practices and enhance mutual recognition of standards. This e:file processing facilitates smoother market access for Indian pharmaceutical products in global markets.
It is an excellent initiative by CDSCO. This will bring India on par with global best regulatory practices. Some of the States like Gujarat have already developed a full-fledged digital process for all types of applications and have been functioning efficiently. This move will speed up the document review and approval process, said Desai.
A word of caution on establishing secured digitized systems and having robust cybersecurity measures in place with traceability is of prime importance. This will ensure the data security. Of course, all this requires related infrastructure, skilled staff and uninterrupted connectivity particularly in remote places, added Desai.
Noting the CDSCO online submission as a welcome move, Sunil Attavar, former president, Karnataka Drugs and Pharmaceutical Manufacturers’ Association, said that it would be great if there was a secure site to upload the data, with strict controls and traceability to ensure that data, much of which will be proprietary and sensitive, will be protected and controlled.
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