2017 Drug Registration in India - Pacific Bridge Medical · 2018-01-18 · •For Indian...
Transcript of 2017 Drug Registration in India - Pacific Bridge Medical · 2018-01-18 · •For Indian...
Copyright © 2017 Pacific Bridge Medical | www.pacificbridgemedical.com1
PRESENTATION ON DRUG REGISTRATION IN INDIA
Presented by Ames Gross, PresidentPacific Bridge Medical7315 Wisconsin Avenue, Suite 609E, Bethesda, MD 20814
www.pacificbridgemedical.comCopyright © 2015 Pacific Bridge Medical. All rights reserved. This content is protected by US and International copyright laws and may not be copied,
reprinted, published, translated, resold, hosted, or otherwise distributed by any means without explicit permission. Disclaimer: the information contained in this report is the opinion of Pacific Bridge Medical, a subsidiary of Pacific Bridge, Inc. It is provided for general information purposes only, and does not constitute professional advice. We believe the contents to be true and accurate at the date of writing but can give no assurances or warranties regarding the
accuracy, currency, or applicability of any of the contents in relation to specific situations and particular circumstances.
Copyright © 2017 Pacific Bridge Medical | www.pacificbridgemedical.com2
REGULATORY FRAMEWORK IN INDIA• The Central Drugs Standard Control Organization (CDSCO) is
the Central Drug Authority for discharging functions assigned to the Central Government under the Drugs and Cosmetics Act. • CDSCO has six zonal offices, four sub-zonal offices, 13 port
offices and seven laboratories under its control.• Major functions of CDSCO:
- Regulatory control over the import of drugs- Approval of new drugs and clinical trials- Meetings of Drugs Consultative Committee (DCC)- Meetings of Drugs Technical Advisory Board (DTAB)- Approval of certain licences as Central Licence Approving
Authority is exercised by the CDSCO headquarters.
Copyright © 2017 Pacific Bridge Medical | www.pacificbridgemedical.com3
INDIAN REGULATORY FRAMEWORK
Copyright © 2017 Pacific Bridge Medical | www.pacificbridgemedical.com4
REGULATORY FRAMEWORK IN INDIAStatutory Functions undertaken by Central Licensing Authority
Statutory Functions undertaken by State Licensing Authority
Laying down standards of drugs, cosmetics, diagnostics and devices
Licensing of drug manufacturing and sales establishments
Laying down regulatory measures, amendments to Acts and Rules
Licensing of drug testing laboratories
To regulate market authorization of new drugs Approval of drug formulations for manufacture
To regulate clinical research in India (approvalof clinical trials)
Monitoring of quality of Drugs & Cosmetics, manufactured by respective state units and those marketed in the state
To approve licenses to manufacture certain categories of drugs as Central Licence approving Authority i.e. for Blood Banks, Large Volume Parenterals and Vaccines & Sera
Investigation and prosecution in respect of contravention of legal provisions
Copyright © 2017 Pacific Bridge Medical | www.pacificbridgemedical.com5
REGULATORY FRAMEWORK IN INDIA
Statutory Functions undertaken by Central Licensing Authority
Statutory Functions undertaken by State Licensing Authority
To regulate the standards of imported drugs
Administrative actions
Work relating to the Drugs Technical Advisory Board (DTAB) and Drugs Consultative Committee (DCC)
Pre- and post- licensing inspection
Testing of drugs by Central Drugs LabsPublication of Indian Pharmacopoeia (IP)
Recall of sub-standard drugs
Copyright © 2017 Pacific Bridge Medical | www.pacificbridgemedical.com6
FDC REGISTRATION PROCESS IN INDIA
Step 1• Determine the classification of FDC• Determine if the FDC requires registration in India
Step 2
• Appoint a Local Authorized Agent to represent the manufacturer in India
• Apply for Market Approval in Form 44• Obtain the Market Registration Certificate in Form 45
Step 3• Apply for Import Registration in Form 40• Obtain Import Registration Certificate in Form 41
Step 4• Apply for Import License in Form 8 and 9• Obtain Import Licence Certificate in Form 10
Step 5 • Marketing in India
Copyright © 2017 Pacific Bridge Medical | www.pacificbridgemedical.com7
1. THE MARKET APPLICATION REVIEW PROCESS
Preliminary scrutiny performed by CDSCO to determine the acceptability of FDC application
Applicant (Indian agent) files Form 44 CDSCO
Letter of denial sent to the applicantAcceptance letter sent to applicant
Acceptable Not- Acceptable
ApplicationsentforSubjectExpertCommittee(SEC)fortechnicaldatareview
SEC schedules a meeting date and publishes the date in SEC recommendations section of the CDSCO website
Applicant submits the following at least 4 weeks prior to the scheduled meeting date: technical literature, executive
summary, and draft Powerpoint to be presented during the meeting
SEC continues its review of the proposed Finished Pharmaceutical Product (FPP) and provides its
recommendations to the DCGI New Drug Approval committee
SEC meeting is held and meeting minutes noted
Market approval is granted in Form 45
Positive recommendationNegative recommendation
Market Approval is denied
Request for additional information
Mfg site inspection (optional)
Copyright © 2017 Pacific Bridge Medical | www.pacificbridgemedical.com8
2. IMPORT REGISTRATION PROCESS
8
Applicant files Form 40 to Import registration division of CDSCO
Application is acceptable
Additional data required
Deficiency letter sent to the applicant requesting for additional information
Import Registration Certificate granted in Form 41. Certificate is applicable to a specific site located outside India
CDSCO evaluates the application
- Timeline: 6-9 months- Validity: 3 yrs
Copyright © 2017 Pacific Bridge Medical | www.pacificbridgemedical.com9
BE STUDY IN INDIA• Applicable guideline - “Guideline for Bioavailability and
Bioequivalence studies” mentioned in Schedule Y of Drugs and Cosmetics Act (IInd Amendment), 2005.• Related guidelines available on the CDSCO website for industry –Revised Checklist for Pre-screening of BA/BE Applications
(Draft 2014) effective from 1st Feb 2014–Neutral Code - labelling–List of Approved BA/BE Centres
Copyright © 2017 Pacific Bridge Medical | www.pacificbridgemedical.com10
BE STUDY OPTIONS IN INDIA
Request for waiver submitted to DCGI
DCGI evaluates if the product falls into the BE waiver category
ProtocolapprovedA request letter sent to the applicant for additional information or changes
BE study conducted as per Schedule Y BA/BE guideline and in DCGI approved centres for conducting BA/BE studies
Revised protocol is submitted for review to IEC
Bio waiver request is rejected
No Yes
Bio waiver request is accepted and forwarded to the Technical committee and Apex committee for opinion
Bio waiver is granted in Form 46
Bio waiver request is rejected
Negative opinion Positive opinion
Applicant to discuss the BE protocol during the SEC meeting
Submit the protocol to Independent Ethics Committee (IEC) for Approval
IEC reviews the protocol
Copyright © 2017 Pacific Bridge Medical | www.pacificbridgemedical.com11
BE WAIVER POSSIBILITYIn India, a biowaiver is granted based on two categories –1. Finished Pharmaceutical Product (FPP) formulation:
- parenteral products, solution for oral use, is a gas, powder for reconstitution as a solution, otic, opthalmic or topical solution, inhalation product or nasal spray.
2. Marketing status: - Approved in India for more than 4 years except for modified
release dosage form [old drugs].
Copyright © 2017 Pacific Bridge Medical | www.pacificbridgemedical.com12
CDSCO INSPECTIONS
• CDSCO inspections may be conducted during review of application.• For Indian manufacturing units the inspection is conducted on-site. • For manufacturing sites located abroad, CDSCO may request for
recent inspection/audit report performed by respective regulatory authority of the country where site is located.• If deemed necessary, CDSCO may perform inspection of the FPP
manufacturing site or BE study site.• Manufacturing site is notified 1 month prior to the inspection date.• CDSCO Inspection fees: FPP Manufacturer is liable to pay USD
5,000 (or its equivalent in Indian rupees) for Expenditure - Inspection fees + travel expenses for inspection that is to be borned by company, as may be required for inspection or visit of manufacturing premises.
Copyright © 2017 Pacific Bridge Medical | www.pacificbridgemedical.com13
PHARMACOVIGILANCE PLAN
• To be submitted at the time of initial marketing approval.• Plan should mention:–Safety data from clinical development–Potential risks of the FDC–Population at risk–Situations not adequately studied–Drug-drug, drug-food interaction information• Commitment to active surveillance.• Protocols for any observational studies planned – these will need
separate approvals.• Safety signals obtained from other countries where product is
approved must be reported.
Copyright © 2017 Pacific Bridge Medical | www.pacificbridgemedical.com14
DRUG PRICING AND REIMBURSEMENT• The National Pharmaceutical Pricing Authority (NPPA) under the Department
of Pharmaceuticals (separate office from CDSCO) enforces price control regulations as per Drug Price Control Order (DPCO) 2013.• DPCO applies to 509 medicines on the National List of Essential Medicines.• Using a market-based approach, a price ceiling is set for essential medicines in
order to ensure affordability.• The maximum retail price is fixed based on the API, route of administration,
dosage form and strength.• Prices of drugs in India are generally low due to indigenous manufacturing
capability and low cost base.• For imported value-added products and new drugs, patients are willing to pay
higher prices that for domestically-made products.
14
Copyright © 2017 Pacific Bridge Medical | www.pacificbridgemedical.com15
T H A N K Y O UF O R Y O U R P A R T I C I P A T I O N A N D A T T E N T I O N
For more information, visit us atwww.pacificbridgemedical.com
Connect with us today:Address: 7315 Wisconsin Avenue, Suite 609E
Bethesda, MD 20814E-mail: [email protected]: (301) 469-3400