Lok Sabha Question No. 2911 (UNSTARRED), answered on 2018-12-28
Subject: Medical Equipment
Ministry: HEALTH AND FAMILY WELFARE
Asked by: K. ASHOK KUMAR, SURESH KODIKUNNIL, A.P. JITHENDER REDDY

## GOVERNMENT OF INDIA MINISTRY OF HEALTH AND FAMILY WELFARE DEPARTMENT OF HEALTH AND FAMILY WELFARE

## LOK SABHA UNSTARRED QUESTION NO. 2911 TO BE ANSWERED ON 28 TH DECEMBER, 2018

## MEDICAL EQUIPMENT

## 2911. SHRI K. ASHOK KUMAR: SHRI KODIKUNNIL SURESH: SHRI A.P. JITHENDER REDDY:

Will the Minister of HEALTH AND FAMILY WELFARE be pleased to state:

(a) whether the Government is aware of the reports in media by the International Consortium of  Investigative  Journalists (ICIJ)  about  large  scale  anomalies  in  AIIMS with  regard  to Medical Devices Adverse Event (MDAE) report and if so, the details thereof and reaction of the Government thereto;

(b) whether the Government maintains a public database of medical devices that have been recalled by companies due to technical problems and if so, the details thereof and the steps taken against those medical device manufacturers;

(c) the details of medical device malfunctioning, or adverse reports, as received by the Indian PharmacopoeiaCommission, Company- wise and device - wise;

(d) whether the Government has any proposal to conduct an investigation in the matter or constitute a high level committee to ascertain facts and if so, the details thereof;

(e)  whether  the  Government  intends to  take  steps  to  ensure  that  the  m edical professional performing or recommending an implant surgery does not have stake in he medical device they are recommending, if so, the details thereof; and

(f) whether the Government has taken any steps to regulate the medical devices market which so far remained unregulated and if so, the details thereof and if not, the reasons therefor?

## ANSWER THE MINISTER OF STATE IN THE MINISTRY OF HEALTH AND FAMILY WELFARE

(SHRI ASHWINI KUMAR CHOUBEY)

(a): The Government is aware of the reports in media by the International Consortium of Investigative  Journalists  (ICIJ).  In  this  regard,  the  "Materiovigilance  Programme  o (MvPI)" is run by Indian Pharmacopoeia Commission under the Ministry of Health & Famil Welfare for strengthening the medical devices safety and performance.

(b): The  Government  of  India  has  notified  the  Medical  Device  Rules  2017  which  are effective from 01.01.2018 . Under the Medical Device Rules, there is a provision for recall medical  devices.  If  a  manufacturer  or  importer  considers  or  has  reason  to  believe medical device is likely to pose a risk to the health of patients, the manufacturer shall i mmediately initiate procedures to withdraw the medical device in question from market and the patients. The information received from manufacturers is analysed by Ce Drugs  Standard  Control  Organisation  (CDSCO)  and Medical  Device alerts  are  issued by CDSCO on its website i.e. www.cdsco.gov.in.

(c): Adverse  reactions/malfunctioning  in  medical  devices  may  happen  due  to  variou reasons like improper usage, improper size, electrical and mechanical problems and def medical devices. It may or may not be related to the device. The details of reports recei under Materiovigilance Programme of India company -wise and device -wise are attached as Annexure.

(d): The Government had constituted a committee to examine the issues relating to faulty Artic ular  Surface  Replacement  (ASR)  hip  implants  which  gave  specific  and  general recommendations  to  strengthen  the  regulatory  system  regarding  materiovigilance,  regi and recall mechanism of medical devices.

(e) & (f): The  Central  Drugs  Standard  Control Organisation  (CDSCO)  under  the Ministry of Health and Family Welfare regulates the safety, efficacy and quality of n medical  devices  under  the  provisions  of  Drugs  and  Cosmetics  Act,  1940  and  Rule thereunder.

Medical Devices Rules, 2017 have been implemented with effect from 01.01.2018 which  have  comprehensive  provisions  for  regulation  of  manufacture,  import,  sale distribution of medical devices covered under the said Act to ensure their quality.  M n 350  medical  devices  and  more  than  250  in - vitro  diagnostics  have  been  brought  under regulation.

ANNEXURE

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| Device category                        | Manufacturer                                                                                                                                                           |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intra-Uterine Contraceptive Devices    | Bayer India, Thane                                                                                                                                                     |
| Catheters                              | BL Lifesciences Pvt Ltd, New Delhi Covidien Manufacturing Solutions Cook India, Chennai Others (Delux surgicals,Klarvoyant Biogenic Pvt. Ltd, Cordis Corporation, etc) |
| Intra-Venous Cannula                   | Vygon India, Gurugram (Lamed, Rompson, Polymedicare etc.)                                                                                                              |
| Cardiac Stent                          | Abbott Vascular, Mumbai Terumo India Pvt Ltd, Gurugram Cook India, Chennai                                                                                             |
| Orthopaedic implant                    | Gurugram Johnson & Johnson Pvt. Ltd., Mumbai Zimmer Biomet, Gurugram                                                                                                   |
| Hernia Graft Heart valve               | Cook Biotech Inc. St. Jude Medical India Pvt. Ltd., New                                                                                                                |
| Others (Gloves, BP Apparatus, Dressing | Delhi Others (Bapuji Surgicals, Jam Healthcare, Ethicon,Smith and                                                                                                      |
| material etc.)                         | Nephew Ltd etc)                                                                                                                                                        |