Home India Ministry of Health and Family Welfare Constitution of State level Committee Regarding the Faulty A...
Date: 2018-09-28 Category: Not Applicable State: Union Government Country: India

Constitution of State level Committee Regarding the Faulty ASR HIP Implant manufatured by M/s DePuy International Ltd U K

Issued by Ministry of Health and Family Welfare · Central Drugs Standard Control Organization

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Executive Summary & Key Takeaways

What it means

  • The gazette notification pertains to the faulty ASR Hip Implant manufactured by M/s DePuy International Ltd. U.K.
  • It instructs State/UT Drugs Controllers to ensure the formation of State Level Committees and advertise the matter in newspapers so that patients can approach these committees or Central Level Committees for claiming compensation.
  • The notification follows up on a previous letter from the Ministry of Health & Family Welfare requesting the formation of State Level Committees and public advertisement.

Key Changes

  • The State/UT Drugs Controllers, as Member Secretaries of the State Level Committees, are requested to ensure the formation of these committees.
  • The State/UT Drugs Controllers are requested to ensure that the matter is advertised in newspapers.
  • The notification includes a list of names, designations, and contact details of representatives from the CDSCO Zonal & Sub Zonal offices.
  • The notification references the Ministry of Health & Family Welfare letter No. X.11035/25/2015-DFQC dated 30.08.2018.

Impact Analysis

Patients

  • Action Item: Ensure effective advertisement of the State Level Committees in newspapers to reach affected patients.

State/UT Drugs Controllers

  • Action Item: Intimate the action taken to the CDSCO office via email (lealcellcdsco.nic.in).

M/s DePuy International Ltd. U.K.

  • Potential Financial Impact: The company may face compensation claims related to the faulty ASR Hip Implants.

CDSCO (Central Drugs Standard Control Organisation)

  • Action Item: Zonal and Sub-Zonal offices should follow up on the matter and intimate compliance to the central office.

Hospitals and Healthcare Providers

  • Action Item: Develop a process to identify and contact patients who received ASR Hip Implants.

Key Entities Referenced

M/s DePuy International Ltd. U.K.: Manufacturer of the faulty ASR Hip Implant. Directorate General Of Health Services: Government of India agency under the Ministry of Health & Family Welfare. Ministry of Health & Family Welfare: Government of India ministry responsible for health policies and programs. Central Drugs Standard Control Organisation (CDSCO): National Regulatory Authority for pharmaceuticals and medical devices in India. State Level Committees: Committees formed at the state level to address compensation claims related to the faulty ASR Hip Implant. Drugs Controller General (I): Head of the Central Drugs Standard Control Organisation (CDSCO). Ministry of Health & Family Welfare letter No. X.11035/25/2015-DFQC dated 30.08.2018: Previous communication from the Ministry of Health & Family Welfare regarding the formation of State Level Committees.
Official Source Record View Original Source →
See Full Document Text
29/Misc/03/2018-DC (389) Government of India Directorate General Of Health Services Ministry of Health & Family Welfare Central Drugs Standard Control Organisiation (Medical Devices & Diagnostics Division) FDA Shawan, Kotla Road, New Delhi-110002 « Date- J_ ~ tt. ~ J...01 To, All Drugs Controllers of States IUT's Subject: Constitution of State Level Committee Regarding the Faulty ASR Hip Implant Manufactured by MIs DePuy International Ltd. U. K.-Reg. Sir/Madam, This is with reference to the Ministry of Health & Family Welfare, Government of India's letter No. X.11035/25/2015-DFQC dated 30.08.2018 addressed to Principal Health Secretaries of all States JUT's (Copy enclosed), wherein, it was requested to form State Level Committees & to advertise the subject matter in news papers so that patients can approach State Level Committees or Central Level Committees for claiming compensation (Copy enclosed). In this regard it is to inform that , as State/UT Drugs Controller is Member secretary of State level committee, you are requested to ensure the formation of the State Level Committees & get the matter advertised in the news papers at the earliest. The list of name, designation & contact details of representatives of respective Zonal & Sub Zonal office of CDSCO is enclosed herewith. This may be given top priority and action taken in the matter may kindly be intimated to this office at the earliest by email onlealcellcdsco.nic.in Yours faithfully, Encl.: As stated above. ~ (Dr. S. Eswara R~ddy) Drugs Controller General (I) Copy with request to follow the matter & intimate the compliance at the earliest to:- All Zonal Offices/Sub Zonal Offices of Central Drugs Standard Control Organisation CC: 1. Principal! Health Secretaries of State /UT 2. PS to JS(R)

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