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CENTRAL DRUGS STANDARD CONTROL ORGANIZATION …

1 GUIDANCE DOCUMENT FOR BA/BE NOC FOR EXPORT B A / B E N O C F O R E X P O R T D I V I S I O N Page 1 CENTRAL DRUGS STANDARD CONTROL ORGANIZATION DIRECTORATE GENERAL OF HEALTH SERVICES MINISTRY OF HEALTH AND FAMILY WELFARE GOVERMENT OF INDIA GUIDANCE DOCUMENT FOR APPROVAL OF BA/BE NOC FOR EXPORT PURPOSE AS PER SCHEDULE Y & TEST LICENCE IN FORM 11 OF DRUGS AND COSMETICS RULES, 1945 BA/BE NOC FOR EXPORT DIVISION 2 GUIDANCE DOCUMENT FOR BA/BE NOC FOR EXPORT B A / B E N O C F O R E X P O R T D I V I S I O N Page 2 draft GUIDANCE DOCUMENT FOR APPLICATION/ APPROVAL OF BA/BE NOC FOR EXPORT PURPOSE AS PER SCHEDULE Y AND TEST LICENCE IN FORM 11 OF THE DRUGS AND COSMETICS RULES, 1945. A large number of applications are being filed to the office of DCG (I) at CDSCO (HQ) by Pharmaceutical companies, both manufacturers and CRO s on behalf of them, requesting for the approval to carry out Bioequivalence studies on Indian subjects for export purpose.

2 guidance document for ba/be noc for export b a / b e n o c f o r e x p o r t d i v i s i o n page 2 draft guidance document for application/ approval of ba/be noc for export purpose as per

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