Lok Sabha Question No. 2997 (UNSTARRED), answered on 2019-12-06
Subject: Case against Johnson & Johnson
Ministry: HEALTH AND FAMILY WELFARE
Asked by: Lavu Sri Krishna Devarayalu

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

## LOK SABHA UNSTARRED QUESTION NO. 299 7 TO BE ANSWERED ON 6 TH DECEMBER, 2019

## CASE AGAINST JOHNSON & JOHNSON

## 2997. SHRI LAVU SRI KRISHNA DEVARAYALU:

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

- (a)  whether  it  is  a  fact  that  Food  and  Drug  Administration  (FDA),  USA,  found  asbesto Johnson baby powder;
- (b) if so, whether Indian Drugs Standard Control Organization has started inve tigation in this regard;
- (c) if so, the details thereof and the kind of help sought/obtained from FDAUSA;
- (d) whether it is also true that there was a case against Johnson and Johnson baby powder Maharashtra  Food  and  Drug  Administration  had cancelled  license  when  it  found  that  baby powder was sterilized by using ethylene oxide which causes cancer; and
- (e) if so, the action taken by the Government and the reasons for repetition of issues same product from same company?

## ANSWER THE MINISTER OF STATE IN THE MINISTRY OF HEALTH AND FAMILY WELFARE (SHRI ASHWINI KUMAR CHOUBEY)

(a) to (c): As per media reports and information provided by M/s Johnson & Johnson India Pvt Ltd., the said firm in USA, had recalled 33000 bottles of Johnson & Johnson's Baby Powder following US FDA's test on a single bottle of the said baby powder that indicated presence of sub- trace levels of chrysotile asbestos contamination.

I n 2018, due to widespread media reports regarding the presence of cancer causing asb in Johnson & Johnson's Baby Powder, Zonal and Sub - zonal offices of Central Drugs Standard Control  Organisation  (CDSCO)  under  the  Ministry  of  Health  &  Family  Welfare  h ad  drawn samples of the said baby powder and of bulk talc raw material used in its manufacturing the  provisions  of  the  Drugs  and  Cosmetics  Act,  1940  &  Drugs  and  Cosmetics  Rules,  194 thereunder.

Further, investigation was conducted at the manufacturing units of Johnson & Johnson Baby Powder located at Mumbai and Baddi. The samples drawn were sent to Regional Drugs

Testing Laboratory (RDTL), Chandigarh for testing.  Government Analyst of RDTL Chandigarh declared the samples as of standard q uality and also stated that asbestos was not detected in t samples analysed. (d)  &  (e):  As  per  the  information  provided  by  Food  and  Drug  Administration  (FDA) Maharashtra,  they  had  conducted  an  inspection  on  the  basis  of  complaint  and  based  on find ings, a show cause notice was issued to the company and thereafter the license was can on 30/03/2013. The firm made an appeal to the Appellate authority of FDA Maharashtra whi rejected the appeal vide order dated 20/06/2013. Subsequently, the  firm  filed  a  Writ  Petition  No.1714/2013  in  Hon'ble  High  Court  of Bombay  challenging  the  order  dated  30/03/2013.  The  court,  vide  order  dated  19/09/2013, aside the order dated 30/03/2013 and also directed that the Appellate Authority should de he matter  afresh.  After  re -examination  of  the  entire  issue,  the  licensing  authority  of  the  F Maharashtra cancelled the manufacturing license of M/s Johnson & Johnson vide order da 15/03/2014. M/s Johnson & Johnson filed a Writ Petition No.98 4  of  2014  in  Hon'ble  High  Court  of Bombay  challenging  the  order  dated  15.03.2014.  The  Court,  vide  order  dated  23.06.20 granted interim order to the petitioner i.e. M/s. Johnson & Johnson. Further,  special  drive  for  the  testing  of  talcum  powder  f or  the  presence  of  asbestos  was carried  out  in  March  2016  by  FDA,  Maharashtra  and  14  samples  of  talcum  powder  were collected and tested for traces of asbestos. However, asbestos was not found present in a

14 samples including baby powder manufactu red by Johnson & Johnson.

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