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Dr. A. Ramkishan

M.Pharm, Ph.D (Pharmacology), FIPS, FTAS, FIPA, FAPAS

Deputy Drugs Controller (India)

Central Drugs Standard Control Organization (CDSCO), Hyderabad

Ministry of Health & Family Welfare, Government of India

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WHO Global Benchmarking Tool (GBT) for Evaluation of National Regulatory System of Biological Products (Human Vaccines)

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Function 2 - Registration and Marketing Authorization (MA): Indicators and Fact Sheets

NRA Assessment

• National regulatory authorities (NRAs) (CDSCO) are the gatekeepers of the supply chain of medical products, and they have a mandate to ensure the quality, safety and efficacy of medicines, vaccines, blood, and blood products, medical devices, including diagnostics and traditional, or herbal medicines.
• The World Health Organization (WHO) has developed a Global Benchmarking Tool (GBT) as part of its five-step capacity building program to assist NRAs, using the tool, they can benchmark their own strengths and areas of weakness, and then engage in a formal benchmarking process together with WHO and international experts in order to formulate an effective and workable institutional development plan.
• The GBT is comprehensive across the entire product life cycle and allows benchmarking to be customized to the needs of the NRA.
• It has evolved from decades of experience using a variety of benchmarking tools, within WHO and other stakeholder organizations.
• By the end of December 2019, 26 countries had undergone formal benchmarking, and a further 54 countries had used the GBT to conduct self-benchmarking exercises assisted by WHO.

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NRA Assessment

• NRA assessment is a process of inspection of entire Regulatory system of India done by Expert team of WHO.
• NRA qualification (passing) by WHO is a precondition for supply /export of vaccines to UNICEF /PAHO by Indian Manufacturers.
• The NRA Assessment started in 2001, followed by 2004, 2007, 2009 ,2012, 2017 and next NRA is scheduled to be in 2024.
• The bench mark and depth of assessment (questionnaire) is being developed by WHO each time
• WHO developed a software for assessment of all regulatory activities based on the maturity levels for each non-compliances.
• The WHO Global Benchmarking Tool (GBT) Revision VI version 1 published in November 2018 and revised again in 2021 is the latest release of the GBT for benchmarking of medicines and vaccines national regulatory systems. This release comprises eight (8) regulatory functions (listed below) under the overarching framework of the national regulatory system (RS)

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NRA Assessment Tool

�“WHO has developed an ‘Assessment Tool’ (a set of questionnaire called as indicators and sub-indicators along with guidance for assessor) since 1999 to assess the various functions and performances of the NRA, revised the tool many times and currently revised in 2015.”

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• India, qualified the assessment test all the time, however in 2008 Indian NRA was disqualified due to :
• Inadequate dossier review
• Poor quality system in NRA
• Poor AEFI system
• Lack of ability to suspend the public sector vaccine manufacturing units

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NRA Assessment - 2008

• In 2012 assessment report, WHO indicated in its findings that the Indian regulatory system that overseas vaccines has continued to raise its performance gradually and had met all critical indicators for vaccine prequalification in several functions.
• However, there was a need to critically monitor some of these indicators until end of 2013 otherwise the functionality can be at risk and performance of the regulatory system cannot be confirmed and validated.
• WHO made number of follow-up visits in India for monitoring of the various recommendations.

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NRA Assessment - 2012

• NRA assessment earlier up-to 2012 used to involve inspection of 6 major functions namely
• Marketing Authorization and Licensing Activities
• Pharmacovigilance Activities including Surveillance of Adverse Events Following Immunization (AEFI)
• NRA Lot release
• Laboratory Access
• Regulatory Inspection
• Regulatory oversight of clinical trials

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NRA Assessment - 2012

• The summary report of assessment was received from WHO in July 2013 and there were some issues in the report which the Ministry considered objectionable related to policy, autonomy of CDSCO, declaration of NIB as CDL, etc.
• The Ministry received full report from WHO in Sep. 2013 after the Ministry with the approval of Secretary, HFW sent through email a letter to the NRA assessment team leader Dr. Lahouari Belgharbi stating therein that there was no conflict of interest in relation to DGHS, the issue of declaring any lab as CDL may be left to Government of India and that WHO’s recommendation should not interfere with the country’s sovereignty.
• With collective efforts and deep involvement of officials of CDSCO, NRA India could convert failure to functionality specifically in case of two indicators AEFI/Pharmacovigilance and Regulatory inspection

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NRA Assessment

• Now the proposed tool involves inspection of 8+1 functions, in which there are 63 indicators and 288 sub-indicators, out of which 150 are critical
• Failure in any of the critical indicator or sub-indicator may lead to disqualification of NRA
• India has been continuously upgrading its regulation, guidelines, SOPs, infrastructure, manpower, training of all the regulators, inspectors since 2008 to maintain the qualified status

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NRA Assessment - 2017

NRA – WHO Assessors

WHO NRA Assessment team includes a wide array of assessors who are highly experienced and experts in their fields. This time CDSCO shall be assessed by 16 assessors from different parts of world (Switzerland, USA, Italy, Germany, Netherlands, Thailand, Egypt, Indonesia, India and SEARO (WHO))

List of assessors are as follows:

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NRA – WHO Assessors

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NRA – WHO Assessors

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NRA Assessment – Process & Procedure

NRA – Maturity Levels

WHO – Global Benchmarking Tool has defined Maturity levels based on the functionality of NRA of respective country

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Results of NRA assessment in 2017

Status of Regulatory Functions

Strength of NRA

• Existence of high level policy/strategy:

National Vaccine Policy, CDSCO IDP, Road map for strengthening of India regulatory land scape, Quality Risk Management and the development of the regulatory system as part of twelfth, five years development plan

• Full implementation of the 2012 IDP
• Managerial commitment to develop and establish QMS
• Financial flexibility
• Increased transparency and availability of information on public domain
• E-governance and online registration(SUGAM)
• Strong and detailed regulatory legal framework

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Results of NRA assessment in 2017

• Human resources - Highly competent staff
• Established procedures - Significant improvement in the quality of MA review activities
• Implementation of electronic review system - SUGAM
• Transparency - Enhanced posting of information on CDSCO website.
• Detailed legal provisions for the conduct of successful pharmacovigilance system
• Roles and responsibilities of stakeholders defined
• Adherence of all stakeholders to guidance documents for pharmacovigilance in line with WHO recommendations.
• India is engaging in proactive pharmacovigilance e.g. independent post authorization safety studies.
• Expertise for signal detection tools and data mining in PVPI
• Stable Passive surveillance system for pharmacovigilance established
• India is now ready to move to the next stage of active surveillance.

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Results of NRA assessment in 2017

• Increased oversight of market control by (increase in Number of samples , increase in penalties) resulted in detection of not qualified products)
• Required MOCK recall from manufacturers.
• CDSCO Online portal project.
• Legal frame work, well structured organization- clear job and responsibility;
• Quality management system (QMS) is fundamental supporting the Licensing of premises in two shared authority, State LA and Central LAA ;
• User friendly website

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Results of NRA assessment in 2017

• To Revisit the strategic objectives and high level policies (NVP) developed a while ago
• To establish a formal process to measure and analyze the regulatory impact (RIA) as part of Good Regulatory Practice (GRP)
• To improve further the document management system to have more details procedures and better control of documents
• Establish a formal process for identifying the risks as part of risk management
• To develop additional Key Performance Indicators (KPIs) to measure not-time related parameters (some areas)
• To increase human resources capacity and work space
• Enhance meeting minutes of expert committees to capture critical discussions related to clinical trial activities
• Enhance vaccine and product specific training for staff
• Improve communication related to vaccine safety concerns to all public health stakeholders
• Data from SMS should be sent to health care providers.
• Introduce Pharmacovigilance Inspections
• Introduce concept of Risk Management Plans to be submitted with the application for marketing authorization
• Introduce legal obligation for industry to immediately report new information on quality, efficacy and safety with impact on benefit risk
• Use already available signal detection tool for vaccine safety
• Further strengthen to improve completeness & timeliness
• Start focus on interpretation of data patterns & active surveillance

Recommendations of NRA assessment in 2017

• Expand oversight of distribution channel for vaccine through applying risk approach
• Enhance Communication, coordination and harmonization in area of market surveillance and control between all levels and relevant stakeholders
• Enhance market surveillances data collection and sharing.
• Publish regulatory decisions and actions related to market surveillance.
• Share findings, data and/or decisions related vaccine safety issues with other International and nationals organizations. updating published information regularly with the current status of Licensing, a summary of the inspection result/report, toward reliance of International public.
• Establish a data base for licensing to support transparency and accountability toward Good Governance
• Integrating CDSCO web with established States web site to share information to the public.
• Maintain the competency of staff in Central-Zonal and state at the same level to maintain business process consistency.

Recommendations of NRA assessment in 2017

Introduction to the tools

• WHO has developed an ‘Assessment Tool’ (a set of questionnaire called as indicators and sub-indicators along with guidance for assessor) since 1999 to assess the various functions and performances of the NRA, revised the tool many times and currently revised in 2015 (renamed as Global Benchmarking Tool) to include following functions:
• National Regulatory System (NRS)
• Registration and Marketing Authorization (RMA)
• Vigilance (PVL)
• Laboratory Access And Testing (LAT)
• Regulatory Inspection
• Clinical Trial’s Oversight (CTO)
• NRA Lot Release (LTR)
• Licensing Premises (LIC)
• Market Surveillance and Control (MSC)

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NRA Assessment Tool

�The revised assessment tool has been renamed as Global Benchmarking Tool) and include following functions [9 Functions, 63 Indicators and 288 Sub Indicators (150 Critical)] as per the GBT 2016

• National Regulatory System (NRS)
• Registration and Marketing Authorization (RMA)
• Vigilance (VL)
• Laboratory Access And Testing (LAT)
• Regulatory Inspection (RI)
• Clinical Trial’s Oversight (CTO)
• NRA Lot Release (LR)
• Licensing Premises (LI)
• Market Surveillance and Control (MSC)

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• Integration of different medical product streams
• Enhanced ability for customization of the tool
• Comprehensive system-based benchmarking
• Adoption of maturity concept based on ISO standard
• Integration of SSFFC related indicators
• Expanded benchmarking of regulatory QMS
• Categorization of the indicators enabling transverse benchmarking
• Link with predecessor tools
• Updating and expansion of regulatory guidelines
• Comprehensive guidance for benchmarking
• Maintenance of functionality concept as part of
• Maintenance of functionality concept as part of eligibility criteria for WHO prequalification

New Feature of WHO Global Benchmarking Tool

NRA Assessment: 2024 - Indicator categories by regulatory function

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WHO Global Assessment Tool 2015�Computer Based User Friendly Assessment Tool

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WHO Global Assessment Tool Mar 2016�Indicators Categorization (cross cutting subjects)

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1. Legal provisions, regulations and guidelines
2. Organization and governance
3. Policy and strategic planning
4. Leadership and crisis management
5. Transparency, accountability and communication
6. Quality and risk management system
7. Regulatory process
8. Resources (HR, FR, Experts, Infrastructure and Equipment)
9. Monitoring progress and assessing impact

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Function 2:���Registration and Marketing Authorization (RMA)�(

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Introduction

• WHO categorized RMA into 6 indicators which are further categorized into 33 sub-indicators and classified them as critical (15) or non-critical (18) and evaluated the functions/procedures of NRA on the basis of same.

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• 8 new sub-indicators introduced by WHO in 2015 under National regulatory System after revision of the 2012 tool.

Overview of Registration and Marketing Authorization (RMA)

• Under Registration and Marketing Authorization (RMA) function, WHO evaluates the overall Registration and Marketing Authorization activities of NRA namely:
• Legal provisions, regulations and guidelines w.r.t. Registration and Marketing Authorization ;
• Arrangement for effective organization and good governance
• Mechanism for promotion of Transparency, Accountability and communication etc.;
• Procedures established and implemented to perform the Registration and Marketing Authorization, Mechanism of monitoring regulatory performance and output, trained and qualified human resources
• Timelines for assessment of the applications and internal tracking system, SmPC, Labelling, complete database of applications received, approved, rejected, suspended and or withdrawn along with essential documentation

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• In this function WHO has introduced new requirement of legal provisions and regulations regarding the limited duration of the validity of the Marketing Authorization and its periodic review which is classified as critical indicator and performance indicators for the function;
• Legal provisions to cover circumstances in which routine MA procedures may not be followed.

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Overview of Registration and Marketing Authorization (RMA)

Indicator: MA01 :Legal provisions, regulations and guidelines required to define regulatory framework of registration and/or marketing authorization

• Sub-indicators:
• MA01.01: There are legal provisions that require the receipt of a registration or marketing authorization (MA) before placing the product on the market.
• MA01.02: There are legal provisions that require the NRA to withhold, suspend, withdraw or cancel an MA if there are concerns regarding quality, safety or efficacy issues.
• MA01.03: There are legal provisions that require demonstration of the product quality, safety and efficacy prior to registration or MA.
• MA01.04: There are legal provisions or regulations limiting the duration of the validity of the MA and requiring periodic reviews of MAs (i.e. renewals).
• MA01.05: There are regulations or guidelines for the definitions, types and the scope of variations along with the required documentation for these variations.
• MA01.06: There are legal provisions to cover circumstances under which the routine MA procedures may not be followed (e.g., for public health interest).
• MA01.07: There are legal provisions or regulations that define regulatory requirements to approve donation of medical products.

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Indicator: MA01 :Legal provisions, regulations and guidelines required to define regulatory framework of registration and/or marketing authorization

• Sub-indicators:

viii. MA01.08: Legal provisions or regulations allow the NRA to recognize and/or rely on MA-relevant decisions, reports or information from other NRAs or regional and international bodies.

ix: MA01.09: Specific guidelines on the quality, nonclinical and clinical aspects are established and implemented.

x: MA01.10: There are guidelines on the format and content for submission of MA applications that are consistent with the WHO or other internationally accepted standards

xi: MA01.11: There are guidelines for MA holders that define the types and scope of variations, the format and content to be used for documenting the variations, and the identification of those variations that require prior approval or notification

xii: MA01.12: There are established guidelines that cover circumstances under which the routine MA procedures may not be followed (e.g., for public- health interest).

xiii: MA01.13: There are guidelines on the content of product information leaflets, SPC-like information, and product packaging and labelling.

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Indicator: MA02 :Arrangement for effective organization and good governance

Sub-indicators:

1. MA02.01: There is a defined structure with clear responsibilities to conduct registration or MA activities.
2. MA02.02: Documented and implemented procedures exist to ensure involvement and communication with all relevant regulatory entities as necessary

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Indicator: MA03 Human resources to perform registration and marketing authorization activities

Sub-indicators:

1. MA03.01: Sufficient competent staff (i.e., education, training, skills and experience) are assigned to perform MA or registration activities
2. MA03.02: Duties, functions, and responsibilities of the staff in charge of MA or registration activities are established and updated in the respective job descriptions
3. MA03.03: Training plan developed, implemented and updated at least once a year for staff in charge of MA or registration activities.
4. MA03.04: The NRA generates and maintains records of staff training activities and training effectiveness verification.

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Indicator: MA04 Procedures established and implemented to perform registration and/or marketing authorization.

• Sub-indicators:
• MA04.01: Documented procedures and tools are implemented for the assessment of the different parts of the application (i.e., quality, and efficacy) and for the assessment of specific requirements applicable to specific classes of medical products
• MA04.02: Documented procedures have been implemented to renew and/or to periodically review the MAs granted
• MA04.03: Documented procedures are implemented for assessing applications for variations of MAs.
• MA04.04: The same criteria apply for assessing applications regardless of the origin of or destination for the medical products (e.g., domestic, foreign, public sector, or private sector).
• MA04.05: An advisory or scientific committee, including external experts is involved in the review of MA applications (as needed).
• MA04.06: Timelines for the assessment of the applications are defined and an internal tracking system has been established to monitor adherence to the targeted time frames�

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Sub-indicators:

vii: MA04.07: There are documented mechanisms to handle non-routine registration or MA requirements in special situations (e.g., public-health interest).

viii: MA04.08: SPC-like, labelling and packaging information are approved by the NRA as part of the MA procedure.

ix: MA04.09: GMP inspection report and/or certification is considered as part of the MA process.

x:MA04.10: The regulations and guidelines for good review practices (GRevPs) are developed or recognized and implemented

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Indicator: MA05 Mechanism exists to promote transparency, accountability and communication.

Sub-indicators:

MA05.01: Web site or other official publication with SPC-like information is available and regularly updated.

MA05.02: Updated list of all medical products granted MA is regularly published and publicly available

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Indicator: MA04 Procedures established and implemented to perform registration and/or marketing authorization.

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• Indicator: MA05 Mechanism exists to promote transparency, accountability and communication.
• Sub-indicators:

iii. MA05.03: A summary technical evaluation report for approved registration MA applications is published and available to the public

iv. MA05.04: A summary technical evaluation report for deferred or rejected registration or MA applications is published and available to the public

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Indicator: MA06 Mechanism in place to monitor regulatory performance and output.

• Sub-indicators:

MA06.01: There is a database of all product applications received, approved, rejected, suspended or withdrawn along with their supporting documentation.

MA06.02: Performance indicators for registration and MA activities are established and implemented.

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New Drugs and CT Rules 2019

• These Rules have come in to force from the date of publication in the Official Gazette, GSR 227(E), i.e. from 19th March 2019 except Chapter for IV which shall come in to force after one hundred and eighty days.
• The said Rules contains 13 chapters and 8 Schedules. They shall apply to all new drugs, investigational new drugs for human use, clinical trial, bioequivalence study, bioavailability study and Ethics Committee.

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The Indian Vaccine Industry……

• Total 23 Vaccine manufacturers in India out of which 8 are Pre-Qualified by WHO for supply to UNICEF/PAHO.
• More than 60% of the total world vaccine are manufactured in India and exported to around 150 countries globally.
• According to new report by IMARC titled “India Vaccine Market Report and Forecast 2018-23, India Vaccine market reached to around 69 billion INR in Year 2017 and growing at CAGR of 18%.

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How Vaccine differ from drugs

• Biological products (Variation)
• Heat sensitive (Cold chain)
• Sensitive to light and freezing
• Limited shelf life
• Mandated by public health programme (EPI or NIP)
• Targeted to healthy children & mothers
• Given for prevention - recipient cannot judge treatment
• Cost per dose, new vaccines are more expensive
• Limited number of products and manufacturers
• Given once or only a few times

CHAPTERS under NDCTR 2019

I - Preliminary

II - Authorities & Officers

III - EC for CT, BA / BE study

IV - EC for Biomedical & Health Research

V - CT, BA / BE study of ND & Inv. ND

VI - Compensation

VII - BA & BE study centre

VIII - Mfg of ND or Inv. ND for CT, BA/BE or R&D

IX - Import of ND or Inv. ND for CT, BA/BE or R&D

X - Import of ND for Sale or distribution

XI - Import or Mfg of unapproved ND for treatment of patients in

Govt. hospitals & institutions

XII - Amendments of D&C Rules, 1945

XIII - Miscellaneous

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• 1st – General principles & practices for CT
• 2nd – Requirement & guidelines for permission to import or mfg of ND for Sale or to undertake CT
• 3rd – Conduct of CT
• 4th – Requirement & guidelines for conduct of BA / BE study of ND or Inv. ND
• 5th – Post market assessment
• 6th – Fee payable for license, permission & registration certificate
• 7th – Formulae to determine quantum of compensation
• 8th – Forms

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SCHEDULES under NDCTR 2019

I. A drug, including active pharmaceutical ingredient or phytopharmaceutical drug, which has not been used in the country to any significant extent, except in accordance with the provisions of the Act and the rules made thereunder, as per conditions specified in the labeling thereof and has not been approved as safe and efficacious by the Central Licensing Authority with respect to its claims; or

II. A drug approved by the Central Licensing Authority for certain claims and proposed to be marketed with modified or new claims including indication, route of administration, dosage and dosage form; or

III. a fixed dose combination of two or more drugs, approved separately for certain claims and proposed to be combined for the first time in a fixed ratio, or where the ratio of ingredients in an approved combination is proposed to be changed with certain claims including indication, route of administration, dosage and dosage form; or

IV. a modified or sustained release form of a drug or novel drug delivery system of any drug approved by the Central Licensing Authority; or

V. A vaccine, recombinant Deoxyribonucleic Acid (r-DNA) derived product, living modified organism, monoclonal anti-body, stem cell derived product, gene therapeutic product or xenografts, intended to be used as drug;

Definition of New Drugs (as per New Drugs and CT Rules 2019)

Vaccine Approval Procedure

Provision for pre-submission meeting

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• Import License (Form10) for r-DNA/Vaccine�Import License (Form-10), Application (Form-8), Undertaking (Form-9)�Registration for Import is online via SUGAM�Market Authorization in CT-19 (DS) or CT-20 (DP)�Registration for Import (Form 41)�Lot release at CDL, Kasauli in case of vaccine�

Fee Structure (6^th Schedule of NDCTR 2019)

• Phase I Rs 300,000
• Phase II Rs 200,000
• Phase III Rs 200,000
• Phase IV Rs 200,000

For reconsideration of application – Rs 50,000.

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• Application for permission to manufacture new drugs or investigational new drugs for clinical trial Rs. 5000 per product

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For reconsideration of application - Rs. 2000 per product

• Pre Submission meeting Rs. 500,000
• Post Submission meeting Rs. 50, 000

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Post Approval Changes -As per Guidance for Industry

Fees & forms for Market Authorization

Reference: NDCT Rules 2019 GSR 227 (E), Sixth Schedule

Fees & Forms for Market Authorization

Reference: NDCT Rules 2019 GSR 227 (E), Sixth Schedule

RMA Auditors�(Dr.Valeria Gigante, Team Lead, AMR, WHO Geneva then FDA Auditor from Italy)�Dr.Robin Lewis, USFDA

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WHO-NRA Assessment 2017 Team

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Changes from GBT 2017 to GBT 2022 in RMA

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Changes from GBT 2017 to GBT 2022 in RMA

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Changes from GBT 2017 to GBT 2022 in RMA

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�Additional information sought in Sub indicators�

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�Institutional Development Plan (IDP) for MA, 2017:�

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�Institutional Development Plan (IDP) for MA, 2017:�

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Initiatives taken up by CDSCO in COVID -19 Pandemic towards approval of Vaccines

• Regulatory guidelines
• Draft regulatory guidelines for development of vaccines with special consideration for covid-19 vaccine
• Guidance for approval COVID-19 Vaccines in India for restricted use in emergency situation which are already approved for restricted use by US FDA, EMA, UK MHRA, PMDA Japan or which are listed in WHO Emergency Use Listing (EUL)

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• Stock Piling & marketing
• S.O.1511(E) Dt. 18.05.2020_Regulations for manufacture and stock of vaccines for COVID-19 under Section 26B
• S.O.553(E) dated 09.02.2022- Stockpiling of new drug under phase 3 of clinical trial_NDCTR,2019

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• Additional Central testing Laboratories
• NIB, Noida
• NIAB, Hyderabad
• NCCS, Pune

List of covid-19 Vaccines approved till date

• https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=ODE5NA==

Draft regulatory guidelines for development of vaccines with special consideration for covid-19 vaccine

• https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NjUwMA==

Guidance for approval COVID-19 Vaccines in India for restricted use in emergency situation which are already approved for restricted use by US FDA, EMA, UK MHRA, PMDA Japan or which are listed in WHO Emergency Use Listing (EUL)

• https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/notice15april21.pdf

S.O.1511(E) Dt. 18.05.2020_Regulations for manufacture and stock of vaccines for COVID-19 under Section 26B and S.O.553(E) dated 09.02.2022- Stockpiling of new drug under phase 3 of clinical trial_NDCTR,2019

• https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NjMzMQ==
• https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=ODEyNQ==

Additional laboratories approved as Central Testing Laboratories for testing of Covid-19 Vaccines

• https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NzM1OQ==
• https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NjcxOQ==
• https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NzU5MA==