Lok Sabha Question No. 5424 (UNSTARRED), answered on 2023-04-05
Subject: Pharma Export
Ministry: COMMERCE AND INDUSTRY
Asked by: Mala Roy

## GOVERNMENT OF INDIA MINISTRY OF COMMERCE & INDUSTRY (DEPARTMENT OF COMMERCE)

## LOK SABHA UNSTARRED QUESTION NO. 5424 TO BE ANSWERED ON 05 th  APRIL, 2023

## PHARMA EXPORT

## 5424.   SHRIMATI MALA ROY:

Will the Minister of COMMERCE & INDUSTRY ( वाणिज्य एवं उद्योग मं त्री ) be pleased to state:

(a) whether the Government has undertaken any survey to assess the impact of incidents of cough syrup adulteration/sub-standard items found in products imported from India in the global market in Indian pharma products;

- (b) if so, the steps that are being taken to restore confidence of importers; and
- (c) the action taken/being taken against these companies?

## ANSWER

okf.kT; ,oa m|ksx ea=ky; esa jkT; ea=h ¼Jherh vuqfiz;k iVsy½

## THE MINISTER OF STATE IN THE MINISTRY OF COMMERCE AND INDUSTRY (SMT. ANUPRIYA PATEL)

(a) & (b): Indian Missions abroad are having regular interactions with the authorities to retain the confidence within the drug regulatory agencies. To build confidence and also to ensure continuity of the  trade,  Pharmaceuticals  Export  Promotion  Council  of  India  (Pharmexcil)  has  led  business delegations to African and Commonwealth of Independent States (CIS) countries and had one-to-one discussions with drug regulating agencies and Pharma trade associations assuring them of the quality of Indian generic products. Pharmexcil is also conducting workshops/training programmes to sensitize the  exporters  on  quality  management  and  to  apprize  them  of  the  international  standards  and  their compliances.

(c): In the two recent incidents of alleged cough syrup adulteration/sub-standard items found in products exported to Gambia and Uzbekistan, following actions have been taken:

(i) In the case of Gambia, a joint investigation was carried out by Central Drugs Standard Control Organization  (CDSCO)  in  coordination  with  State  Drug  Controller,  Haryana  against  M/s  Maiden Pharmaceuticals Limited, Sonepat (Haryana) and control samples of the drugs were drawn for test and analysis by Regional Drug Testing Laboratory (RDTL), Chandigarh. RDTL Chandigarh has declared the samples to be of standard quality and negative for both Diethylene Glycol (DEG) and Ethylene

Glycol (EG). However, based on violations observed in Good manufacturing Practices, State Drugs Controller,  Haryana  has  issued  an  order  to  M/s  Maiden  Pharmaceuticals  Limited  on  11.10.2022 stopping all the manufacturing activities at Sonepat with immediate effect in public interest.

(ii) In the case of Uzbekistan, CDSCO in coordination with State Drugs Controller, Uttar Pradesh conducted  a  joint  investigation  at  M/s  Marion  Biotech  Pvt.  Ltd.,  Noida  (U.P.)  and  collected  drug samples  from  the  manufacturing  premises  for  test  and  analysis  by  RDTL,  Chandigarh.  The manufacturing  license  of  the  firm  was  suspended  by  State  Licensing  Authority,  Uttar  Pradesh  on 09.01.2023. RDTL, Chandigarh has forwarded the test reports of 30 drug samples so far, wherein 24 samples of drugs/raw material were declared as "Not of Standard Quality" out of which 22 samples fall under the category of adulterated/ spurious.

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