The gazette notification summarizes the minutes of a meeting held on September 8, 2014, by the Directorate General of Health Services, Central Drugs Standard Control Organisation (CDSCO).
The meeting involved Joint Drugs Controllers (I), Deputy Drugs Controllers (I), and Assistant Drugs Controllers (I) to review application status, address pendency issues, highlight achievements, assess timeline adherence, discuss administrative matters from the previous 100 days, and plan for the upcoming 100 days.
The decisions made during the meeting are documented in the notification.
Key Changes
A proposal will be submitted to the Ministry to strengthen the administration wing with efficient manpower to handle enforcement and administrative matters. DDC(I) ARK is responsible for this.
All divisions must present their achievements in application disposal (approvals, rejections) and submit task accomplishments for the past and next 100 days. Division Heads are responsible.
Steps taken to expedite Inspection, Marketing Authorization approvals, Clinical Trial NOC, and API certification were reviewed.
Divisions must submit work done related to organizing meetings, training, developing procedures, and addressing public grievances.
Senior officers are responsible for monitoring activities within their respective divisions, emphasizing transparency, accountability, honesty, and credibility.
Simple language should be adopted in drafting and smooth disposal of applications.
Administrative and technical support will be provided to NIC for initiating work on a Clinical Trial database. ADC(RB) is responsible.
A proposal for finalizing guidelines for accreditation of EC/investigator & clinical trial site will be forwarded. ADC(RB) is responsible.
Administrative orders will be issued for each division to ensure all outward letters are sent by post. DDA(D) & DDC (ARK) are responsible.
A proposal to construct a temporary enclosure for almirahs for better record keeping (implementation of PMO order) will be actively followed up. DDA(D) is responsible.
Impact Analysis
Internal Stakeholders (CDSCO Divisions)
Action Items: Implement measures to enhance transparency and accountability within each division.
Ministry of Health and Family Welfare
Action Items: Review and approve the proposal for strengthening the administration wing.
National Informatics Centre (NIC)
Action Items: Coordinate with CDSCO to initiate work on the Clinical Trial database.
Clinical Research Community (EC/Investigators/Clinical Trial Sites)
Action Items: Await the finalized guidelines for accreditation and prepare for compliance.
Applicants (Pharmaceutical Companies, API Manufacturers)
Action Items: Ensure applications are complete and accurate to facilitate faster processing. Monitor the CDSCO website for updates on application status.
Key Entities Referenced
Directorate General of Health Services: The apex body in the field of health charged with handling all health matters in the country.
Central Drugs Standard Control Organisation (CDSCO): The national regulatory authority for Indian pharmaceuticals and medical devices. It is responsible for approval of new drugs, clinical trials, laying down standards for drugs, control over the quality of imported drugs, and coordination of the activities of State Drug Control Organizations.
Joint Drugs Controller (I) [JDC(I)]: Official within CDSCO responsible for drug regulation.
Deputy Drugs Controller (I) [DDC(I)]: Official within CDSCO responsible for drug regulation.
Assistant Drugs Controller (I) [ADC(I)]: Official within CDSCO responsible for drug regulation.
DDC(I) ARK: Deputy Drugs Controller (I), potentially with initials ARK.
Division Head: Head of a specific division within CDSCO.
ADC(RB): Assistant Drugs Controller, potentially with initials RB.
DDA(D): Drugs Deputy Assistant (D)
NIC: National Informatics Centre
PMO: Prime Minister's Office
API: Active Pharmaceutical Ingredient
EC: Ethics Committee
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)