Home India Ministry of Health and Family Welfare Reconstitution of Central Expert Committee to determine the ...
Date: 2024-12-02 Category: Not Applicable State: Union Government Country: India

Reconstitution of Central Expert Committee to determine the quantum of compensation in respect of faulty ASR Hip implant manufactured by M/s. DePuy international Limited U.K now M/s. Johnson & Johnson Private Limited implanted in lndia

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 Ministry of Health & Family Welfare has reconstituted a Central Expert Committee to address issues related to faulty ASR Hip Implants manufactured by DePuy International Limited, U.K. (now Johnson & Johnson Private Limited) and imported by DePuy Medical Private Limited, Mumbai (now Johnson & Johnson Private Limited).
  • The committee will determine compensation and medical management for affected patients.

Key Changes

  • A Central Expert Committee has been reconstituted under the chairmanship of Dr. Ajay Kumar Shukla, Professor of Orthopaedics, RML Hospital (New Delhi).
  • Affected patients can approach either the Central Expert Committee or State Level Committees.
  • Patients approaching the Central Expert Committee can contact the Legal Cell, CDSCO (HO) via email (legalcell@cdsco.nic.in) or post.
  • Patients who have already submitted claims do not need to re-apply.
  • Patients intending to approach State Level Committees can contact the concerned State/UT Drugs Controllers.

Impact Analysis

Patients

  • Action: Patients should decide whether to approach the Central Expert Committee or the State Level Committee based on their convenience and location.

Johnson & Johnson Private Limited (formerly DePuy International Limited and DePuy Medical Private Limited)

  • Action: The company should review its internal processes to prevent similar incidents in the future.

Central Drugs Standard Control Organisation (CDSCO)

  • Action: CDSCO should maintain clear records of all claims and communications related to the ASR Hip Implants.

State / UT Drugs Controllers

  • Action: State/UT Drugs Controllers should coordinate with the Central Expert Committee to ensure consistency in the compensation process.

Key Entities Referenced

Ministry of Health & Family Welfare, Govt. of India: The government ministry responsible for health policy and initiatives in India. Central Expert Committee: A committee reconstituted to determine compensation and medical management for patients affected by faulty ASR Hip Implants. Dr. Ajay Kumar Shukla: Professor of Orthopaedics, RML Hospital (New Delhi) and Chairman of the Central Expert Committee. DePuy International Limited, U.K. (now M/s. Johnson & Johnson Private Limited): The manufacturer of the faulty ASR Hip Implants. DePuy Medical Private Limited, Mumbai (now Johnson & Johnson Private Limited): The importer of the faulty ASR Hip Implants in India. Central Drugs Standard Control Organisation (CDSCO): The national regulatory body for pharmaceuticals and medical devices in India. State / UT Drugs Controllers: The drug regulatory authorities at the state and union territory level in India. State Level Committee: State-level committees that also address issues related to faulty ASR Hip Implants.
Official Source Record View Original Source →
See Full Document Text
File No. DCGI/Legal/Misc-41/2020-DC Government of lndia Directorate General of Health Services Central Drugs Standard Control Organisation (Leoal Cell) FDA Bhawan, Kotla Road, New Delhi - 110 002 Dale.. 0!- t2_ Z^>2\ Public Notice Sub: Reconstitution of "Central Expert Committee" to determine the quantum of compensation in respect of faulty ASR Hip lmplants manufactured by M/s. DePuy lnternational Limited, U.K. (now M/s. Johnson & Johnson Private Limited) implanted in lndia - reg. The Ministry of Health & Family Welfare, Govt. of lndia (New Delhi) has reconstituted a Central Expert Committee to examine issues related to the faulty ASR Hip lmplants manufactured by M/s. DePuy lnternational Limited, U.K. (now M/s. Johnson & Johnson Private Limited) and imported by M/s. DePuy Medical Private Limited, Mumbai (now Johnson & Johnson Private Limited). The Central Expert Committee is reconstituted under the chairmanship of Dr. Ajay Kumar Shukla, Professor of Orthopaedics, RML Hospital (New Delhi) to determine the quantum of compensation as admissible and medical management for the affected patients who were implanted with faulty ASR Hip implant. The affected patients who were implanted with faulty ASR Hip lmplant and are suffering from disability and other losses may approach either Central Expert Committee or State Level Committee as per their convenience. ln case the affected patrents intend to approach the Central Expert Committee, they may write an e-mail or send the hard copy by post / by hand to Legal Cell, CDSCO (HO) FDA Bhawan, Kotla Road, New Delhi - 110 002, Email lD: leoalcell@cdsco.nic.in The ASR patrents who have already submitted their claim application before the State / UT Level Committee or Central Expert Committee, need not file any fresh claim application. ln case the affected patients intend to approach State Level Committee, they may write to concerned State / UT Drugs Controllers, who will be the Member Secretary of State Level Committee. g uvanshi) Drugs Con ller General (lndia)

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