Lok Sabha Question No. 4972 (UNSTARRED), answered on 2023-03-31
Subject: Deaths due to Contaminated Injection
Ministry: HEALTH AND FAMILY WELFARE
Asked by: Dushyant Singh

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

## LOK SABHA UNSTARRED QUESTION NO.4972 TO BE ANSWERED ON 31 ST  MARCH, 2023

## DEATHS DUE TO CONTAMINATED INJECTION

## 4972: SHRI DUSHYANT SINGH:

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

- (a) whether the Government is aware of the eight adverse events leading to five deaths at PGI due  to  using  a  contaminated  injection  named  Propofol  manufactured  by  Nixi  Laboratories Pvt. Ltd., if so, the details thereof;
- (b) the steps taken/proposed to be taken by the Government in this regard;
- (c) whether the Government is also aware that though the samples were taken by the CDSCO and the Himachal Drug Control Department from the same batch, they had a contradictory report concerning the safety of the drug;
- (d)  if  so,  the  reasons  for  such  variation  in  drug  testing  and  the  steps  taken  to  remedy  this variation; and
- (e) the number of drugs recalled after failing quality tests due to impurities, stating year of manufacture,  name  of  the  manufacturer,  number  of  units  shipped  pre-test  for  the  last  five years?

## ANSWER THE MINISTER OF STATE IN THE MINISTRY OF HEALTH AND FAMILY WELFARE (DR. BHARATI PRAVIN PAWAR)

(a) to (e): There were 8 reports of suspected Adverse Drug Reaction (ADR) including 5 deaths allegedly due to use of Propofol Injection. The suspected ADRs included refractory hypotension, anuria, haematuria, tachycardia, hyperbilirubinemia, elevated AST and multiple deaths.

CDSCO in  coordination  with  State  Licensing  Authority,  sent  sample  of  impugned batch No. (PNL-220316) manufactured by M/s Nixi Laboratories Pvt. Ltd. to Regional Drugs Testing  Laboratory  (RDTL),  Chandigarh  for  test  and  analysis.  As  per  report  of  the Government Analyst, the sample was declared Not of Standard Quality (NSQ).

State Drugs Controller, Himachal Pradesh issued order to stop manufacturing under Rule 85(2) of Drugs Rules,  1945 for the  product  'Propofol  Emulsion  for  Injection'  under generic or any brand name.

Another  joint  investigation  was  carried  out  by  CDSCO  in  coordination  with  State Licensing  Authority  (SLA),  Himachal  Pradesh  at  M/s.  Nixi  Laboratories,  Kalamb  District Sirmour Himachal Pradesh. As the above Test Report of the impugned batch of product was challenged by the Firm under the Drugs & Cosmetics Act & Rules; Hon'ble Court of Chief Judicial Magistrate, Chandigarh sent the sample of same batch to Central Drug Laboratory (CDL), Kolkata for test and Analysis. The impugned sample was declared Standard Quality by CDL, Kolkata.

The manufacturing, sale and distribution of drugs in the country are regulated under the provisions of Drugs & Cosmetics Act, 1940 and Rules, 1945. The regulatory control over the manufacture, sale and distribution of drug in the country is exercised through a system of licensing  and  inspection  by  the  State  Licensing  Authorities  (SLAs)  appointed  by  the respective State Governments. The data regarding drugs recalled after failing quality tests is not maintained centrally by CDSCO.

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