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 List of Approved BA/BE Centers 2019-Jan-29 181 KB
2 Documents to be submitted for Bioequivalence Study for export applications 2014-Jan-04 283 KB
3 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
4 Document required for approval of BA-BE center 2014-Jan-04 58 KB
5 Neutral Code - labelling 2014-Jan-04 1143 KB
6 Revised Checklist for Pre-screening of BA/BE Applications (Draft 2014) effective from 1st Feb 2014 2014-Jan-04 327 KB
7 Guidance Document for BA/BE NOC Applications for Export Purpose (Draft 2014) 2014-Jan-04 294 KB
S.no Title Release Date Download Pdf Pdf Size
1 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 Notice dated 18-10-2019 2019-Oct-18 470 KB
2 Name Of Approved Clinical Centres 2018-Apr-08 262kb
3 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
4 Documents to be submitted for Bioequivalence Study for export applications 2018-Jan-01 92kb
5 Document required for approval of BA-BE center 2017-Jan-01 58kb
6 Notice regarding SUGAM Online 2016-Sep-21 1,820KB
7 Extension of validity of approval of BA/BE Centre from 01 (one) year to 03 (three) years. 2016-Sep-05 45KB
8 Notice regarding for online BA/BE for Export 2016-Aug-22 1,290KB
9 Notice regarding meeting 12 july 2016 CDSCO 2016-Jul-05 302KB
10 Notice 2015-Aug-11 312KB
11 Revised Checklist for Pre-screening of BA/BE Applications (Draft 2014) effectiv 2014-Feb-01 327kb
12 Guidance Document for BA/BE NOC Applications for Export Purpose (Draft 2014) 2014-Jan-25 294kb
13 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