gr-cis.com

As the government reviews an overhaul of the drug regulatory process, rules related to clinical trials may be further eased and timelines for approvals shortened to four to six months from around six to eight months now.  

The central drug regulator plans to fast track the approval process for clinical trials while ensuring that the contract research organisations (CROs) involved in the tests comply with stricter quality and compliance checks.  

This comes two months after the drug regulatory agency eased rules related to clinical research — a move that was frowned upon by patient rights groups. These rules let investigators undertake as many trials as approved under the watch of the designated ethics committee and could risk patient lives, groups like Swasthya Adhikaar Manch earlier told ET.  

“(There will be) changes to the (regulations) to make it both easy and stringent,” a senior health ministry official told ET, speaking about the government’s upcoming move on the condition of anonymity.  

According to the official, the changes include a reduction in processing and approval time for clinical trials here while ensuring that companies adhere to higher quality standards.  

The government has so far halved the clinical trial processing and approval timeline which previously would, in some cases, take up to a year and half, said the official. “The target is to reduce (the entire process) further by 30-40%.” Clinical trial regulations will also be tightened on quality parameters, focusing on aspects like the profile of the recruited patients and the CROs enrolling them, said the official. For this purpose, CROs across the country will be inspected for compliance with Good Clinical Practice (GCP) standards, the official added. 

The government has reduced the timeline by measures like increasing the frequency of meetings of the committees granting the approvals and waivers, said another senior ministry official who also preferred to remain anonymous. The Subject Expert Committee, for instance, now meets once a month as compared to once every three months.  

It has also introduced an online system to receive and process clinical trial applications faster. 

http://economictimes.indiatimes.com/news/economy/policy/government-looks-to-fast-track-approvals-for-clinical-trials/articleshow/54840399.cms?from=mdr 

notice-dated05-10-2016

CDSCO has published notice that online application for Global Clinical Trial application is live and effective 24 Oct 216, it is mandatory to file application online.

Although at present hardcopies of application also needs to be submitted along with online submission.

The report of committee under the chairmanship of Prof. Y.K.Gupta has been published by CDSCO. There were three meeting held among the committee members and the committee has also met with the stents manufacturers and associations of stents manufacturers.

In the all the three meeting of the committee, the members has suggested

• not to include coronary stents into NLEM(National List of Essential Medicines) because of concerns over price control.
• There are considerable difference between drugs and medical devices interns of manufacturing process, product characteristic, risk involved, training of doctors and marketing etc. Hence the essentiality criteria used for electing medicines in NLEM might not be applicable for medical devices.

But in the conclusion of the report the committee has recommended that coronary stents should be included in NLEM, which will surely have repercussion on the profits of the manufacturers of coronary stents.

report-of-cornory-stents

DCGI office lashes to FDC(Fixed Dose Composition) Pharma companies who has not submitted the phase IV study protocol to be reviewed by Expert Committee. It is good to see that DCGI office is becoming stringent where they were suppose to be stern and making the companies accountable for their actions.

noticesept1

The department which seems to be dormant few months back are on toes with new zeal and motivation. The motivation is to make India number 1 destination for clinical studies. Everyday there is new announcement, notice, circulars coming from CDSCO to make the department, process,and system more user friendly, efficient, transparent  and above all Industry cordial.

To make this much more better, CDSCO has launched today GCP Inspection checklist which is a superb tool to be used by Pharma companies or CRO industry. The companies can use this checklist to be Inspection ready.

GCPInspChecklist16

The workshop on “Online Process for Grant of NOC for Clinical Trials” was conducted on 24 Aug 2016 was a great success. Dr. V.G.Somani (ADCGI) was present during the workshop. The workshop started at 11:00 am at CDAC office NOIDA and completed at 18:00 hrs.

Find attached the Minutes of the Meeting in Details

Minutes of the Meeting for Workshop on Online Application for CT

CDSCO has published a notice dated 18 Aug 2016 wherein a hands-on workshop on “Online Process for Grant of NOC for Clinical Trials” has been organised on 24th August, 2016 between 11 A.M. – 4 P.M. at CDAC NOIDA premises (Centre for Development of Advanced Computing- Academic Block, B 30, Sector-62, Institutional Area, Noida 201307).
The On-Spot registration to the workshop will be done on 24th Aug 2016 itself on first-come first serve basis. Only first 30-participants (one or maximum two person from each Applicant firm/Institution) be accommodated in hands-on training.
This is one of the best initiative taken by CDSCO and it would be great if more participant can attend this workshop. There is no cost to attend this workshop.

NOTICEDATED18_08

In line with various amendment which CDSCO has published in this month, the biological division of CDSCO has amended the Import/Export policy for Human biological samples for commercial purposes.

The amended notification dated 04 Aug 2016, was published on 11 Aug 2016. This is yet another industry friendly amendment which will further boost the clinical studies in India. Click the below link to see the complete notification.

notification 19-2015-2020

The meeting held at the DCGI office on 10th Aug 2016 was very informative. The objective of the meeting was to demonstrate the steps for registration and application for CT NoC through the portal on CDSCO website.

There were around 70 representative from Sponsor companies like Pharma, Biotech and CROs attended the meeting. Find below the minutes of the meeting for detail information

Minutes of the Meeting at CDSCO office

CDSCO has launched an online portal “SUGAM” (www.cdscoonline.gov.in) on 14 Nov 2015. The portal is intended for filing applications for various services rendered by CDSCO.

In the first phase, filling of application for import and registration of Drugs and Devices  were launched. Now the services is being extended to online submission of CT applications. For the same there is a meeting scheduled on 10 Aug 2016 at 11:30 am at FDA Bhawan, New-Delhi. There will be live demonstration on software also.

notice sugam (Online application for Clinical Trials