Home India Ministry of Health and Family Welfare Details of rejected applications of Human Vaccine Manufactur...
Date: 2023-03-15 Category: Not Applicable State: Union Government Country: India

Details of rejected applications of Human Vaccine Manufacturers or Importers (Form CT-18/CT-21) 2020

Issued by Ministry of Health and Family Welfare · Central Drugs Standard Control Organization

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Executive Summary & Key Takeaways

What it means

  • The gazette notification provides details regarding rejected applications from Human Vaccine Manufacturers or Importers using Form CT-18/CT-21 for the year 2020.

Key Changes

  • For the year 2020, there were no rejected applications from Human Vaccine Manufacturers or Importers (Form CT-18/CT-21).
  • The notification explicitly states 'Nil' for Name of Firm, Name of Vaccine, and Indication, corresponding to the year 2020.
  • The format number for this notification is QMS-GNL-019/F01(b)-00.

Impact Analysis

Human Vaccine Manufacturers/Importers

  • Action Items: Review application processes and data from subsequent years to identify trends and ensure continued compliance and successful application outcomes.

Government (Regulatory Bodies)

  • Action Items: Analyze application data from 2020 to identify factors contributing to the zero-rejection rate. Compare with other years to identify areas for improvement in the evaluation process or applicant support.

Public Health

  • Action Items: Monitor vaccine availability and uptake to ensure public health needs are met.

Key Entities Referenced

Human Vaccine Manufacturers/Importers: Entities involved in the manufacturing or importing of human vaccines. Form CT-18/CT-21: Application forms used by Human Vaccine Manufacturers or Importers. QMS-GNL-019/F01(b)-00: Format number of the notification.
Official Source Record View Original Source →
See Full Document Text
Annexure - I(b) Details of rejected applications of Human Vaccine Manufacturers or Importers (Form CT- 18/CT-21) Year 2020 S.No. Name of Firm Name of Vaccine Indication Date of Rejection 1 Nil Nil Nil Nil Format No. QMS-GNL-019/F01(b)-00.

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