Regulatory Affairs India Synthes Medical Pvt Ltd

Presented by: Vivek Malhotra (AM Regulatory Affairs) 9 November 2011

Contents

Regulatory Organogram Synthes India Regulatory Authority in India Regulatory approval process Fees List of documents required Re-Registration Clinical trial Regulatory

Regulatory Organogram Synthes India

ANIL DEWAN Finance Director

VIVEK MALHOTRA Assistant Manager Regulatory Affairs

STARK STEFANIE Manager RA Asia Pacific

Indian Regulatory Authority

CDSCO regulates medical devices registration and import. CDSCO is controlled by the Drug Controller General India (DCGI). Foreign manufacturers must apply for registration certification for their manufacturing premises and for the individual devices to be imported from the registered site. Applications can be made by Indian subsidiary / authorized agents of foreign firms in India. Import license applications should be made using Form 40 and information and undertakings specified in Schedule D(I) and Schedule D(II) should be duly signed by the manufacturer. For new device registration form 44 is also included. The process of receiving import registration can take up to 9-11 months (6-8 months for registration and 2-3 months for Import permit) for new registration and 5-6 months for change notification or re-registration. Once we have import registration (valid for three years) for a drug, we can apply for a simple import license via Form 8 and Form 9, which is needed for customs clearance.

Regulatory Authority Organogram

Regulatory work flow

Synthes India Regulatory Stark, Stefanie Switzerland, Waldenburg

Submitted via liasioning agent

CDSCO office of DCGI

4-5 Months

6 Months
Approval letter

Deficiency Letter
2-3 Months

Apply for import license using Form 8, pay applicable fees to CDSCO and obtain Import License Form 9.

Registration Required

Manufacturing site registration Medical Device registration Import license for the registered device Wholesale and warehouse license.

Indian HA website http://cdsco.nic.in/Medical_div/medical_device_ division.htm

Fees

A fee of US $ 1500 (US $ One Thousand Five Hundred only) for registration of premises A fee of US $ 1000 (US $ One Thousand only) for registration of Medical Devices for import Re Registration fees after 3 years for every Medical Device and premises.

List of documents required

Application/Cover Letter Cover letter Power of Attorney, signed stamped and Notarized Form 40 Wholesale drug License (Form 20B and Form 21B) notarized copy and form 41. Registration fees for 1000USD Volume I (Legal Documents) Schedule DI and Schedule DII Free Sale Certificate ISO 13485:2003 Full Quality assurance certificate Declaration of Conformity Date first sold and country name Complaint Stats (PMS) Instructions For Use (IFU) Price in the country of Origin Volume II Sterilization and Shelf life documents

List of documents required for Registration

Volume III Essential Requirements Checklist Label Master Document Clinical Evaluation Manufacturing Flowchart Functional & Design Requirements and Verification & Validation Matrix First Article inspection Biocompatibility Risk Management Post Marketing Surveillance Volume IV Literature

Approval letter

Re-Registration
Registration is valid for a period of 3 years. The Re-Registration application is filled after three years. The process and fee structure of Re-Registration remains the same as for initial registration.

Clinical Trials
Clinical trials guidelines are given in Scheudle Y of Drugs and Cosmetics Act 1945 Schedule Y, the current regulator (CDSCO Central Drugs Standard Control Organization) enforced law in India has been established under Drugs and Cosmetic Act 1945.

The regulations to be followed when conducting clinical trials in India are clearly documented to a large extent in this document. Schedule Y for India is a law and not a mere guideline.
Schedule Y in line with ICH-GCP (International Council of Harmonization and Good Clinical Practice) standard was put forth in 1995. Since then multiple revisions to schedule Y took place to provide a healthy environment for clinical research to be conducted in India

Clinical trial
Approvals and Registration need: NOC/Approval to conduct a clinical trial Approval to import the test drug Approval/NOC to export biological samples Registration of trial on CTRI website (Indian version for clinicaltrial.gov)

Clinical Trial
Fee

I. For Feasibility Study (i.e. Safety and efficacy study); which is equivalent to Phase I trials in case of drugs: Rs 50, 000/II. For Pivotal Study (i.e. Confirmatory trials); which is equivalent to Phase II/III trials in case of drugs: Rs 25, 000/-

Timelines

CTRI approval takes one week.

Clinical Trial
Application requirements
1 Covering Letter 2 Form 44, Import Lic application and Export NOC application. 3 Fee in TR6 challan 4 Delegation of Responsibility 5 Protocol 6 Global Regulatory Status of the Device and clinical trial. 7 Investigators Undertaking 8 Ethics Committee Approval 9 Informed Consent Form 10 Case Record Form 11 Patient Record Form 12 Relevant Published Literature 13 Investigators Brochure 14 Suspected Unexpected Serious Adverse Reaction (SUSAR) 15 Affidavit from the sponsor 16 Any other specific relevant information 17 Clinical Study Report, if any

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