Bioavailability or Bioequivalence Approval Process India

Aryan Panwar

Aryan Panwar

Published on: Jul 1, 2026

Shatakshi Sharma

Updated on: Jul 1, 2026

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Introduction

This procedure outlines the legal framework and compliance steps for obtaining Approval for conducting a bioavailability or Bioequivalence Study of a new drug or Investigational New Drug in India. It defines the mandatory documentation, fee structures and application forms required by regulatory authorities to verify safety and quality standards.

Applicable Provisions

Documents Required

The applicant shall submit the following documents as per the Second Schedule, along with the application in Form CT-05:

1. Brief description of the drug and the therapeutic class to which it belongs
2. Chemical and pharmaceutical information
3. Published reports of Pharmacokinetic and Pharmacodynamics studies carried out in healthy subjects or patients demonstrating safety and tolerability of the molecule
4. Prescribing information
5. Undertaking by the Investigator in original duly signed on a company letterhead as per Table 4 of Third Schedule
6. Copy of registration certificate issued by Central Licencing Authority
7. Sponsor’s authorisation letter duly signed by the Authorised Signatory on company letterhead
8. The study protocols, Informed Consent Form or Patient Information Sheet along with audio-visual recording system as per requirements of Second Schedule
9. Copy of approval of protocol from the Ethics Committee, if available
10. Copy of registration of the Ethics Committee under rule 8 from the Central Licencing Authority
11. The study synopsis
12. Undertaking letter from the sponsor stating that complete medical management in accordance with rule 40 and an undertaking letter from the sponsor stating that compensation in case of study relate injury or death shall be provided in accordance with rule 39
13. Certificate of Analysis (COA) of representative batches (both Test and Reference formulations) to be used in the Bio-Equivalence study along with dissolution profile in case Oral Solid dosage forms
14. For multiple dose BE study adequate supporting safety data and Pharmacokinetics or Pharmacodynamics should be submitted covering the duration of period for which the study has to be conducted
15. For all Injectable, the sub-acute toxicity should be submitted on the Test product of the sponsor, studied in at least two species for minimum 14 days. If regulatory guidance is available provide a copy of the same
16. For conducting Bio-Equivalence studies with reference to Cytotoxic drugs, Hormonal preparations, Narcotic and Psychotropic substances and radioactive substances in healthy human subjects a Scientific justification with special emphasis on Safety of subjects with a proper risk mitigation strategy should be submitted. If regulatory guidance is available provide a copy of the same
17. For conducting Bio-Equivalence studies with reference to cytotoxic drugs, Hormonal preparations, Narcotic and Psychotropic substances and radioactive substances in Patients a scientific justification with special emphasis on Safety with a proper risk mitigation strategy should be submitted.

Process for Grant of Permission

Any person, Institution, or organization that intends to conduct a bioavailability or bioequivalence study of a new drug or an investigational new drug in human subjects shall obtain permission by submitting an application Form CT-05 to the Central Licensing Authority along with relevant documents and fees as specified below:

No fee shall be payable for conducting a bioavailability or bioequivalence study by an institution or organization owned or funded wholly and partially by the Central Government or a State Government.

Approval

The Central Licensing Authority, if satisfied after scrutiny of the information and documents furnished with the application, grant the permission to conduct bioavailability or bioequivalence study for a new drug or investigational new drug in Form CT-07.

Reconsideration of Application

In case the Central Licensing Authority rejects the application under Form CT-05, the Applicant may request the Authority to reconsider the application within a period of sixty (60) working days from the date of rejection of the application on payment of the fee as specified in the Sixth Schedule and submission of the required information and documents.

Validity of Approval

Approval granted in Form CT-07 shall remain valid for a period of one (1) year from the date of its issue, unless extended by the Central Licensing Authority.

Conditions of Approval for Conduct of Bioavailability or Bioequivalence Study

The permission granted by the Central Licensing Authority to conduct bioavailability or bioequivalence study under Rule 34 shall be subject to following conditions, namely:

1. Every site must secure protocol approval from a Rule 8 registered Ethics Committee before starting.
2. Sites without an EC can use an external, registered EC located within the same city or a 50 km radius.
3. If an EC rejects a protocol, details must be sent to the Central Licensing Authority before approaching another committee.
4. The Central Licensing Authority must be notified within 15 working days of receiving EC approval.
5. Studies must only be conducted at centres registered with the Central Licensing Authority under Rule 47.
6. The study must be registered with the Clinical Trial Registry of India before enrolling the first subject.
7. Studies must strictly follow the approved protocol, New Drugs and Clinical Trials Rules, and GCP guidelines.
8. Detailed reasons for early study termination must be reported to the Central Licensing Authority within 30 working days.
9. Serious Adverse Events must be analyzed and reported to the Central Licensing Authority, EC, and the institute within 14 days.
10. Complete medical management and injury compensation must be provided, with details sent to the Central Licensing Authority within 30 days of the order.
11. Death or permanent disability compensation must be provided, with details sent to the Central Licensing Authority within 30 days of the order.
12. Sponsor premises and study centres must remain open for unexpected Central Licensing Authority inspections, searches, and document seizures.
13. The first subject must be enrolled within one year of permission, or a Central Licensing Authority extension is required.

Cancellation or Suspension

Where the Permission Holder fails to comply with any provision of the Act and these Rules, the Central Licensing Authority may, after giving a show cause notice and an opportunity of being heard, by an order in writing, suspend the permission for such period as considered appropriate or cancel the permission.

Frequently Asked Questions (FAQS)