Lok Sabha Question No. 377 (UNSTARRED), answered on 2023-02-03
Subject: Deaths due to Cough Syrup
Ministry: HEALTH AND FAMILY WELFARE
Asked by: Adoor Prakash

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

## LOK SABHA UNSTARRED QUESTION NO.377 TO BE ANSWERED ON 03 RD  FEBRUARY, 2023

## DEATHS DUE TO COUGH SYRUP

## 377: ADV. ADOOR PRAKASH:

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

- (a) whether the Government has conducted any probe into death of children in Gambia and Uzbekistan after consuming cough syrup made in the Country;
- (b) if so, the details thereof;
- (c) whether the Government has taken any action in this regard;
- (d)  whether  the  Government  received  any  communication  from  the  concerned  countries  in this matter; and
- (e) if so, the details thereof?

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

(a) to (b): Subsequent to reports of deaths of children in Gambia, Central Drugs Standard Control Organisation (CDSCO) in coordination with State Drug Controller, Haryana carried out  investigation  at  the  manufacturing  unit  of  M/s  Maiden  Pharmaceuticals  Limited,  to ascertain the facts that allegedly led to the death of children in Gambia.

Joint investigation was conducted by CDSCO and State Drug Controller during which it  was  revealed  that  the  State  Drug  Controller  had  given  licenses  to  the  said  company  for manufacture  of  four  drugs,  for  export  purpose  only.  These  drugs  were  not  licensed  for manufacture and sale in India, and the said drugs are not marketed or distributed in India.

Control samples of the aforementioned drugs from the manufacturing unit were drawn and sent for test and analysis to Regional Drug Testing Laboratory, (RDTL) of CDSCO by the investigating team.

As per report of the Government Analyst, the samples have been declared to be of standard  quality.  The  said  samples  were  found  to  be  negative  for  both  Diethylene  Glycol (DEG) and Ethylene Glycol (EG).

Similarly in case of Uzbekistan, CDSCO in coordination with State Drugs Controller, Uttar Pradesh conducted a joint investigation at M/s. Marion Biotech Pvt. Ltd., Noida, Uttar Pradesh to ascertain the facts that allegedly led to the death of children in Uzbekistan. Drug samples  were  drawn  from  the  manufacturing  premises  under  the  provisions  of  Drugs  & Cosmetics Act, 1940 for test & analysis.

(c): Based on investigations conducted, which revealed violation of Good Manufacturing Practices (GMP), State Drugs Controller, Haryana issued show cause notice to M/s Maiden Pharma under Rule 85(2) of the Drugs Rules, 1945 and order have been issued for stopping all  the  manufacturing  activities  of  M/s  Maiden  Pharmaceuticals  at  Sonipat  with  immediate effect for violation of GMP.

Similary, based on investigations conducted by State Drugs Controller, Uttar Pradesh manufacturing  license  of  M/s.  Marion  Biotech  Pvt.  Ltd.,  Noida,  Uttar  Pradesh  has  been suspended with immediate effect for violation of GMP.

(d) & (e): As informed by CDSCO,  no  communication  has been received from Government of Gambia that use of the products manufactured by M/s Maiden Pharmaceuticals Limited, Sonipat has led to the death of children in their Country.

However,  a  communication  has  been  received  in  Ministry  of  Health  and  Family Welfare from the Ministry of Health of the Republic of Uzbekistan informing that the use of the drug 'Doc-1 Max' Syrup manufactured by M/s. Marion Biotech Pvt. Ltd, Noida resulted in  severe  side  effects  that  led  to  the  death  of  children  and  upon  testing  the  said  drug  has revealed presence of Ethylene Glycol and/or Diethylene Glycol.

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