Bioequivalence NOC for Drugs | BE – NOC
In pharmacology, Bioequivalence refers to the similarity in the rate and extent of absorption of a generic or test drug compared to a reference or brand-name drug. When two pharmaceutical products are considered bioequivalent, it means they should have the same therapeutic effect and safety profile when given to patients at the same dose.
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The office of the Drugs Controller General (India) at the CDSCO (HQ) FDA Bhavan in New Delhi has been reviewing applications on behalf of pharmaceutical firms requesting approval to conduct BE studies on Indian subjects with various pharmaceutical dosage formulations.
BE-NOC refers to the No Objection Certificate issued by this directorate for the conduct of bioequivalence studies in human subjects. If the firm wishes to conduct BE studies, it must submit a detailed report and documents in accordance with the checklist. The permission to conduct a bioavailability or bioequivalence study in Form CT-07 is valid for one year from the date of issuance.
All BE-NOC applications should be submitted to DCGI in the categories listed below:
- A new molecule not approved in India but approved by other countries.
- New drugs approved in India within period of one year
- New Drugs approved within period of more than 1 year & less than 4 years
- Drug products in modified release form irrespective of their approval status
- Old drug (Drugs approved more than 4 years)
Procedure for Obtaining a BE - NOC in India:
- Obtaining Login credentials: To obtain a BE - NOC, the applicant must first register in an online portal and create a Login ID and Password
- Documentation: The applicant must produce documents and upload them online accordingly. All documents must meet the rules of The Drugs And Cosmetic Act, 1940
- Fees: The applicant must pay the required fees online by the requirements as per The Drugs And Cosmetics Act, 1940, The Drugs And Cosmetics Rules, 1945.
- Inspection: Following the submission of documentation, the Licensing Authority will inspect the premises and verify all the documents uploaded in the system.
- Issue of BE - NOC: Post verification of the documents.the licensing authority will grant the BE - NOC in Form CT-07.
Pre - Requisites / Documents required for BE - NOC:
- Form CT - 05: Any person, institution, or organisation intending to conduct a bioavailability or bioequivalence study of a new or investigational new drug in human subjects must obtain permission from the Central Licensing Authority by submitting Form CT-05.
- Approval from EC: Anyone planning to conduct a clinical trial, bioavailability study, or bioequivalence study must first obtain approval from an Ethics Committee.
- Details of Drugs: The applicant has to mention details of the drugs mainly name, therapeutic class, dosage form, composition and indications.
- Clinical Trial Site Details: Name and address of the site has to be clearly mentioned
- Firms Constitution Documents: Photo ID / Partnership Deed & ROF registration receipt / Certificate of Incorporation / Trust Registration / HUF Deed / Society Registration depending on the type of constitution
- Details of proprietor/partner/ Director/Trustee etc.: Details of proprietor/director/trustee etc. mentioning their Name, Qualification, DOB, Phone Number, and Email id.
- Regulatory status in other countries: Details of the countries where the drug is marketed approved, or withdrawn along with the Free sale certificate.
- Undertaking: Undertaking by the Investigator in original duly signed on a company letterhead
- Registration Certificate: Registration certificate of Bioequivalence Study Centre in Form CT 09
- Risk Mitigation Strategy: A scientific justification with a special emphasis on Safety and a proper Risk Mitigation Strategy should be submitted
- Certificate of Analysis (COA): Certificate of Analysis (COA) of representative batches (both Test and Reference formulations) to be used in the BE study, as well as dissolution profile if Oral Solid dosage forms are used.
All above requirements are general in nature, however depending on the nature of the drug, disease and studies further specific information may also be required to be furnished by the firm. The applicant has to pay a fee of two lakh rupees as specified in Sixth Schedule of The New Drugs And Clinical Trials Rules, 2019.
For drugs approved elsewhere in the world and absorbed systemically, bioequivalence with the reference formulation should be carried out wherever applicable. These studies should be conducted under the labelled conditions of administration.
Obtaining a permission for conduct of bioavailability or bioequivalence study can be time-consuming and the licensing procedure consists of steps that require a clear and thoughtful method. Any blunder during the registration procedure may result in the applicant being denied the certificate. We reduce the likelihood of application rejection and ensure that permissions are issued quickly and without complications.
You can apply for a Fresh permission in Form CT – 07 / Renewal of Permission / Amendment in License / Change in Constitution / Surrender of License through M/s. The Permiso and obtain the application reference number within 2 days. If you have any issues or facing any difficulty with the application, you can call +91 8104691667 or email us at info@thepermiso.com.
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Bioequivalence NOC for Drugs Registration Procedure
