198 Minutes of Meeting 2014-Sep-08 22kb

QA/Meeting minutes/47/12 Directorate General of Health Services Central Drugs Standard Control Organisation FDA Bhawan, New Delhi-110002

Minutes of Meeting held on 08.09.2014 in the Conference Room first floor FDA Bhawan

A meeting was held on 8th September, 2014 involving all JDC (I), DDC (I) and ADC (I) to review the status of application, issues related to clearance of pendency, any specific achievement, meeting of timeline, administration issues in the last 100 days and work plan for coming 100 days. The decisions in the meeting are summarized below:

1. It was decided to urgently put up the proposal to the Ministry for strengthening administration wing and deputing efficient manpower in administration for handling of all enforcement activities and administration matter. Responsibility-DDC(I) ARK
2. All the divisions were directed to present their achievement related to fast disposal of applications including approvals, rejections and submit task accomplished in last 100 days and to be accomplished in next 100 days. Responsibility-Division Head
3. Steps taken to expedite the various issues related to relevant decision  Inspection, Marketing Authorization approvals, Clinical Trial NOC, API certification  Organizing of meeting, training, procedures developed and addressing of public grievances were asked to be submitted in the work done by various division.
4. Discussion held on organizing and managing archival, attendance, issues related to transparency, accountability, honesty, credibility to work. It was reiterated that senior officers are responsible for the entire division and should monitor the activities of their respective division. Responsibility - Division Head
5. It was decided to adopt simple language in drafting & smooth disposal of application.
6. Discussion held on providing all administrative and technical support to NIC for initiating work on Clinical Trial database. Responsibility - ADC(RB)
7. Forwarding the proposal for finalizing the guideline for accreditation of
   EC/investigator & clinical trial site. Responsibility - ADC(RB)
8. Administrative orders to be issued for respective division for issuance of all the outward letters by post only. Responsibility - DDA(D) & DDC (ARK)
9. For implementation of PMO order in respect of better record keeping, a proposal to
   construct temporary enclosure for almirah is to be followed up actively. Responsibility- DDA(D)