Central Drugs Standard Control Organization

Directorate General of Health Services
Ministry of Health & Family Welfare
Government of India

BA/BE

Bioavailability (BA) : Bioavailability refers to the relative amount of drug from an administered dosage from which enters the systemic circulation and the rate at which the drug appears in the systemic circulation.

Bioequivalence (BE): Bioequivalence of a drug product is achieved if its extent and rate of absorption are not statistically significantly different from those of the reference product when administered at the same molar dose.

The office of Drugs Controller General (India) at CDSCO (HQ) FDA Bhawan, New Delhi has been receiving applications from applicants requesting for the approval to carry out BA/BE studies with various pharmaceutical dosage formulations on Indian subjects. The office of DCG(I) would like to ensure the demonstration of the safety and tolerability of generics against corresponding innovator drugs; to ensure they are comparable and safe for consumption by human subjects. An Assessment of "interchangeability" between the investigational and the innovator product is carried out by a study of "in vivo equivalence" or "bioequivalence" (BE). In view of the above, the office of DCGI would like to ensure the uniformity of documents to be submitted to this Directorate for review and approval of BE-NOC for export to meet tenets of Schedule Y of Drugs and Cosmetics Act 1940 & Rules 1945 and also Indian Good Clinical Practices (GCP) guidelines.

The applicants submit the application for BE NOC & Test Licence through online Sugam Portal in applicable checklist. The application will be processed by the Assistant Drugs Inspector/Drugs Inspector (Reviewing Officer) and send to the ADC(I) (Nodal Officer) for further review. The Nodal Officer will send the application to DDC(I) (Deputy Decision Authority)/JDC(I) (Decision Authority) for recommendation for approval then DCG(I) (Licensing Authority) will grant the BE NOC & Test Licence to the applicant through Online Sugam Portal.

S.no Title Release Date Download Pdf Pdf Size
1 BA-BE Study Centre Approval Under New Drugs and CT Rules 2019 2020-Mar-30 136 KB
2 List of Approved BA/BE Centers 2019-Jan-29 181 KB
3 Documents to be submitted for Bioequivalence Study for export applications 2014-Jan-04 283 KB
4 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 2014-Jan-04 934 KB
5 Guidance Document for BA/BE NOC Applications for Export Purpose (Draft 2014) 2014-Jan-04 294 KB
6 Neutral Code - labelling 2014-Jan-04 1143 KB
7 Revised Checklist for Pre-screening of BA/BE Applications (Draft 2014) effective from 1st Feb 2014 2014-Jan-04 327 KB
8 Document required for approval of BA-BE center 2014-Jan-04 58 KB
S.no Title Release Date Download Pdf Pdf Size
1 Name of approved Bio - Analytical Labs till DATE 28.02.2020 2020-Feb-28 12 KB
2 Updated BA-BE Study Centre List on 29.01.2019 2019-Apr-02 154 KB
S.no Title Release Date Download Pdf Pdf Size
1 Conduct of BA-BE Study for Export purpose in present situation due to outbreak of COVID-19 2020-Jun-09 599 KB
2 Notice regarding Stability data for BA/BE study in Human for export 2020-Feb-21 384 KB
3 Notice regarding sub-acute toxicity study report for injectable products for BA/BE study in human for export 2020-Feb-21 350 KB
4 Notice regarding Permission to conduct BA/BE study and clinical trial 2020-Feb-21 346 KB
5 Notice regarding Processing of application for BA/BE permission issued in Form CT-07 and Import Licence issued in Form CT-17 for Export 2020-Feb-21 228 KB
6 Processing of Post Approval Changes to BA/BE permission issued in CT-07 and Import Licence issued in Form CT-17 for Export 2020-Jan-27 261 KB
7 Notice dated 18-10-2019 2019-Oct-18 470 KB
8 Name Of Approved Clinical Centres 2018-Apr-08 262kb
9 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 2018-Jan-01 934kb
10 Documents to be submitted for Bioequivalence Study for export applications 2018-Jan-01 92kb
11 Document required for approval of BA-BE center 2017-Jan-01 58kb
12 Notice regarding SUGAM Online 2016-Sep-21 1,820KB
13 Extension of validity of approval of BA/BE Centre from 01 (one) year to 03 (three) years. 2016-Sep-05 45KB
14 Notice regarding for online BA/BE for Export 2016-Aug-22 1,290KB
15 Notice regarding meeting 12 july 2016 CDSCO 2016-Jul-05 302KB
16 Notice 2015-Aug-11 312KB
17 Revised Checklist for Pre-screening of BA/BE Applications (Draft 2014) effectiv 2014-Feb-01 327kb
18 Guidance Document for BA/BE NOC Applications for Export Purpose (Draft 2014) 2014-Jan-25 294kb
19 Requirement of Obtaining Approval from the Office of Drugs Controller General of India (DCGI) Prior to Initiation of activity of Bio Analytical Laboratory for the Purpose of Analysis of Samples Obtained from Bio Availablity and Bio Equivalence Studies 2014-Jan-09 140kb
S.no Title Release Date Download Pdf Pdf Size