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Wednesday, January 4, 2017

CDSCO (CENTRAL DRUGS STANDARD CONTROL ORGANIZATION) has published their inspection/visit plat for 2017 for vaccine manufactures in India

Image result for cdsco logo

GOVERNMENT OF INDIA,
CENTRAL DRUGS STANDARD CONTROL ORGANIZATION,
DIRECTOR GENERAL OF HEALTH SERVICES,

MINISTRY OF HEALTH AND FAMILY WELFARE.

The Central Drugs Standard Control Organization (CDSCO) is the Central Drug Authority for discharging functions assigned to the Central Government under the Drugs and Cosmetics Act. CDSCO has six zonal offices, four sub-zonal offices, 13 port offices and seven laboratories under its control.

Major functions of CDSCO: 

1. Regulatory control over the import of drugs, approval of new drugs and clinical trials, meetings of Drugs Consultative Committee (DCC) and Drugs Technical Advisory Board (DTAB), approval of certain licences as Central Licence Approving Authority is exercised by the CDSCO hqrs.

CDSCO (CENTRAL DRUGS STANDARD CONTROL ORGANIZATION) has published their inspection/visit plat for 2017 for vaccine manufactures in India.

Central Inspection Plan using Risk based approach of Vaccine manufacturing units in 2017

The CDSCO has categorised by Zonal wise the detailed Inspection Plan -2017.


Note:

1.   Additionally, Inspections for selected prequalified vaccine facilities shall be planned as and when Inspections are planned by WHO for prequalification and Central Inspection Plan shall be updated accordingly.

2.   Further it is pertinent to mention that all biological products inspections for other than investigation/grant/renewal of license, shall be carried out usually once in a year, unless otherwise justified based on risk based analysis of the firms, products and issue requiring inspection as per Directorate Office Memorandum no File No X-11026/143/16-BD dated 20.12.2016.

Source: CDSCO


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