2017 Drug Registration in India - Pacific Bridge Medical · 2018-01-18 · •For Indian manufacturing units the inspection is conducted on-site. •For manufacturing sites located

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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.


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.


INDIAN REGULATORY FRAMEWORK


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


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


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


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)


2. IMPORT REGISTRATION PROCESS

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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


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


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


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].


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.


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.


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.

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Documents

2017 Drug Registration in India - Pacific Bridge Medical · 2018-01-18 · •For Indian manufacturing units the inspection is conducted on-site. •For manufacturing sites located