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FEASIBILITY OF MANAGEMENT INFORMATION SYSTEM AT DDA 

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Background Purpose Methodology Result Conclusion  

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Department of Drug Administration (DDA)  registered  in 1979 under the MOHP enacted the Drug Act 2035 DDA has the role to ensure  quality, safe and effective medicines and  medical products used in Nepal Provides licensing, registration and  renewal of medicines and supplies, in the public and  private sector DDA to have a well-functioning  MIS that covers DDA's roles and  responsibilities at central and decentralized levels DDA's MIS to support decision making,  impact assessment and to cover  more DDA roles and responsibilities. To identify MIS at DDA this study evaluates : - satisfaction and usability of DAMS,  efficiency and effectiveness of DAMS - explores future needs and  compares DAMS with the other system, - compared variables including  costs,  maintenance, resources ,  licensing fees and training needs.   

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The purpose of this feasibility study is to : Assess feasibility of strengthening the DDA MIS  Provide a stronger tool for decision making and impact assessment  Cost effective MIS by comparison  Identify strength and weaknesses of DAMS other globally available information systems  Provide most feasible and sustainable IT based solution for the DDA .

USAID MEDICINES, TECHNOLOGIES, AND PHARMACEUTICAL SERVICES (MTaPS) PROGRAM

Feasibility study of management information system to evaluation of strength and weaknesses of the existing DAMS based on : Interview of DDA staff ( before COVID-19 lock-down ) Interviews and a questionnaire-based survey (after COVID-19 lock-down)     Total 15 from central level DDA staff, 2 from provincial branch offices and 2 clients at central level

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The results are presented in two sections;  1. Survey responses: covering  interviews and questionnaire findings and 2. Comparative analysis  

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Survey responses:  The responses were almost evenly distributed  between registration, inspection and  management division. A survey was distributed to 30 staff of the DDA,  where 12 are responded:  

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1. Survey responses:  Suggested changes to existing  processes or task in section  The process of dossier evaluation / application process should be  improved according WHO standards for medicine registration Records should be kept on-line for history and  easy access All functional modules of applications should be  registered in DAMS. Online Access to documents regarding  inspection of pharmacy,  product and industry also in the field Access to information/documents across different sections Need to develop detailed checklist for GMP audit and  pharmacy inspection In some application cases the processes may vary  as compared to general processes for the following : (note - list all the processes needed : generic, variation, renewal,  withdraw) drugs which are  new molecules and also drugs not mentioned  in the pharmacopoeia; the drugs which need  analytical method validation and  BA/BE reports (Pallets forms and  their combination); and  the drugs which are combination and  vary in dosage form.  

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1. Survey responses:  Suggested changes to existing  processes or task in section The flow of work should be  synchronized with other sections through (automated ) online system,  Need to incorporate functional modules of post market surveillance submission and  reporting involving testing laboratory and  Inspection into DAMS. Audit plan is most important, should be developed Establish a written audit procedure  Assuring the confidentiality of the outcomes of the audit and  audit reports is extremely important GMP requires that the auditor must be  properly qualified. Work to establish a good working relationship with those we audit.  

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Forms response chart. Question title: How are paper files stored? . Number of responses: 12 responses.

About DAMS: 6 out of 12 respondents are using DAMS 4 out of the 6 is daily users Ease of use in average is  2.6 on a scale from 1 (difficult) to 5 (easy) 

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1. Survey responses:  Problems in DAMS: Slow Working, (Only some pages such as accessing  complete database of products,  pharmacy etc. are slow working in above) DAMS needs continuous updating according  to new problems recognized during use Poor UI/UX. Some tasks of renewal and variation were not working  frequently. (eg. renewal provision and re-apply  for renewal, static words and  numerical that need to change , most of the variation update,  marketing approval products can't be  seen, missing tippani history of manufacturing license, etc) System design failure, not good user design interface. Poor reporting systems,  not effective information extraction and  visualization tools are available. No retrieval for needed  information as per users demand. No page is loading due to server and  browser compatibility. storage for uploading files is minimal so some files are  left, without uploading, and sometimes, uploaded  files disappear if any change made in variation process  

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Forms response chart. Question title: Do you encounter any of these problems in DAMS?. Number of responses: 6 responses.

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Suggested Improvements in DAMS Renewal and product variation through DAMS (is being  upgraded currently)  Complete cycle enrolling all the workload of inspection division,  and management division also. It would be so nice that the quantity of imported  raw materials issued in a custom office connecting  to the DAMS will be helpful to rectify /track the diversion and  misuse of some raw materials by the manufacturer Should be user friendly Better reporting with different search options, Online monthly, quarterly and annual reports Stored file security should be  enhanced, to control the access of Client (customer),  so that files already stored  cannot be omitted by client without the consent of DDA.  

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Reports in DAMS (current): New Product application, Existing Brand names, Molecules registered already, Company registered and their products, Price comparison, Products (brand name) registered  for certain molecules etc. Application log, Renewal of product, Variation module, Transparency and Permission, Reports related to Manufacturing license and  marketing authorization, variation update, etc.  

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Which reports could be included to improve DAMS ? Products information for inspection, decisions for price control, certain GMP category only,  nepali  labelling requirements, and registering only after auditing  etc Certificate Printing issues encounter sometimes.  Renewal of product,  Variation module, Un-Interactive UI." Reports related to Raw materials,  Reports related to history of variation, and  Tippani  as required by the authorized person.

Status reporting to track registration processing Information about molecules and brands,  information about industry and importers and pharmacy  Report generation with different search options, like Manufacture, Pharmacy and Medicine. Provision to generate online monthly, quarterly and annual reports Any variation made, such a report should be included.

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2. Comparative analysis Comparison Matrix of Medicines Registration Processes and MIS in different Countries

Process parameter Bangladesh Ethiopia Mozambique Namibia Ghana Indonesia Australia EMA, Europe Standard practice Pharmadex DAMS   Pre-Submission Eligibility Request X X X X X X X √ X X X   Application Pre-inspection report √ X X X X D X X X X X X   Applicant Information √ √ √ √ √ √ √ √ √ √ √   Fee payment √ √ √ √ √ √ √ √ √ √ √   Application form √ √ √ √ √ √ √ √ √ √ √   Dossiers √ √ √ √ √ √ √ √ √ √ √   Samples √ √ √ √ √ √ √ √ √ √ √   Screening/ (EMA Pre-Submission) Application Coding √ √ √ √ √ √ √ √ √ √ √   Payment confirmation √ √ √ √ √ √ √ √ √ √ √   Product information √ √ √ √ √ √ √ √ √ √ √   Category of distribution √ √ √ √ √ √ √ √ √ √ √   ATC Classification √ √ √ √ √ √ √ √ √ √ X   Addresses √ √ √ √ √ √ √ √ √ √ √   Declarations √ √ √ √ √ √ √ √ √ √ √   Dossier content √ √ √ √ √ √ √ √ √ √ √   Recordings and data capture √ √ √ √ √ √ √ √ √ √ √   Acknowledgements √ √ √ √ √ √ √ √ √ √ X   Dossier Assignment and Assessment (EMA Scientific Evaluation) Assessors data √ √ √ √ √ √ √ √ √ √ √   Distribution records √ √ √ √ √ √ √ √ √ √ X   Internal Assessors √ √ √ Q √ √ √ √ √ √ √ √   External Assessors √ √ √ C X √ √ √ √ √ √ X   Decision making/ communication Assessors data √ √ √ √ √ √ √   √ √ √   Technical Committee √ X √ √ √ √ √ √ √ √ X   Head/ director of Registration X √ √ X X X X X X X X   Head of Agency X √ √ X X X X X X X X

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Process parameter Bangladesh Ethiopia Mozambique Namibia Ghana Indonesia Australia EMA, Europe Standard practice Pharmadex DAMS     Application Pre-inspection report √ X X X X D X X X X X X Post-registration Appeals √ √ √ √ √ √ √ √ √ √ X Deferrals √ √ √ √ √ √ √ √ √ √ X Quality and Safety update reports √ √ √ √ √ √ √ √ √ √ X List of registered products √ √ √ √ √ √ √ √ √ √ √ Applicants database √ √ √ √ √ √ √ √ √ √ √ manufacturers database √ √ √ √ √ √ √ √ √ √ √ Dossier tracking records √ √ √ √ √ √ √ √ √ √ √ Dossier Archiving records √ √ √ √ √ √ √ √ √ √ √ Pre-registration  Laboratory Analysis X X √ X √ X X X X X X Application type (Pathways) Variation  √ √ √ √ √ √ √ √ √ √ √ Renewal of registration √ √ √ √ √ √ √ √ √ √ √ New Chemical Entities √ √ √ √ √ √ √ √ √ √ √ Generics √ √ √ √ √ √ √ √ √ √ √ Complementary medicines √ √ √ √ √ √ √ √ √ √ √ Herbal medicines √ √ √ √ √ √ √ √ √ √ √ Public Health Products √ √ √ √ √ √ X X √ X √ Veterinary √ X X X √ X X √ √ √ X Key: √   – the parameter is included in the country registration process	 X  – the parameter is not included in the country registration process  Q  – internal assessors for quality part of dossier   C  – external assessors for clinical part of dossier D  –   required at decision making for new applicants only

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2. Comparative analysis:  Feasibility Analysis: In the following table we have made a feasibility analysis between the two options that we find realistic. Option A: DAMS expanded to include new functions and strengthened to accommodate the requested requirements and Option B:  Pharmadex

Variable DAMS PHARMADEX Comments Registration module Module available but needs updating to fit new document review procedures Development cost needed Module available with more functionalities updated to WHO review guidelines No cost In DAMS registration module for renewal and variation need to be updated, while Pharmadex already has this.  Pharmacovigilance module Not available will need to be developed Development cost needed The module is developed in Mozambique. Some adaptation to Nepal needed. Limited modification costs needed Pharmacovigilance module available in Pharmadex not in DAMS Import export module Not available will need to be developed Development cost needed The module is developed in Mozambique. Some adaptation to Nepal needed. Import and Export module available in Pharmadex not in DAMS Inspection module Not available will need to be developed Development cost needed Planned but not available yet. Some development cost needed 50% of Inspection modules developed into DAMS and need to be finalized for the remaining portion. Reporting and Visual Dashboard  Not available will need to be developed Development cost needed Planned but not available yet. reports already exist in Pharmadex. Development costs needed Registration report has developed and need to finalize and incorporate by developing other modules into DAMS Licensing fee System developed for DDA  Pharmadex is capable of recording licensing fees   Maintenance  Per Annum Cost: $5000 No per Annum Cost requested for maintenance Pharmadex is updated by MSH globally so no maintenance cost is required.  Training  Per Annum Cost: $5000 Per Annum Cost: $5000 New training for all freshers and continued training every year,  refresher training. The cost expected to be the same LAN setup with local server, manageable switch, router and dedicated internet connectivity  Cost: $5000 Cost: $5000 IT infrastructure need to be improved for both MIS system (DAMS or Pharmadex)

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Variable DAMS PHARMADEX Registration module Module  available  but needs updating to fit new document review procedures Development cost needed Module  available  with more functionalities updated to WHO review guidelines No cost Pharmacovigilance module Not available will need to be developed Development cost needed The module is  developed  in Mozambique. Some adaptation to Nepal needed. Limited modification costs needed Import export module Not available will need to be developed Development cost needed The module is  developed  in Mozambique. Some adaptation to Nepal needed. Inspection module Not available will need to be developed Development cost needed Planned  but not available yet but planned at global level. Use the same developer for this. Maybe some of the code too.  Some development cost needed Reporting and Visual Dashboard   Not available will need to be developed Development cost needed Planned  but not available yet. but planned at global level Basic But many reports already exist in Pharmadex. Development costs needed Licensing fee System developed for DDA  Pharmadex is capable of recording licensing fees

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This feasibility study is to suggest  A  MIS solution for the DDA to improve  its information management to enhance  and support regulatory functions aligned  with WHO guidance MIS to generate strategic information that can be  used to increase transparency,  accountability and good governance within the Regulatory Agency. To evaluated strengths and weaknesses of DAMS and  compared a registration function of DAMS with that of the Open Source solution Pharmadex. DAMS most of the limitations are  overcome by Pharmadex. Pharmadex has been identified  as a regulatory system that can be  considered for Nepal DDA having features: - currently being used in Bangladesh,  Namibia, Ethiopia and Mozambique. -  open source code to customize  the system as per DDA's needs. - Development is supported  by USAID, so the latest version of Pharmadex will become  all future users of Pharmadex. Reporting features of : - List of registered medicines - List of medicines coming to expiration -  Time for registration   

MTaPS Program Nepal

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