Lok Sabha Question No. 2984 (UNSTARRED), answered on 2023-03-17
Subject: Quality of Drugs
Ministry: HEALTH AND FAMILY WELFARE
Asked by: Gaurav Gogoi

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

## LOK SABHA UNSTARRED QUESTION NO.2984 TO BE ANSWERED ON 17 TH  MARCH, 2023

## QUALITY OF DRUGS

## 2984: SHRI GAURAV GOGOI:

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

- (a) whether WHO has raised an alert over any products of any Indian firm, since 2014;
- (b) if so, details of those products and the producer;
- (c) whether India's apex drug regulator had undertaken any inspection based on such alert by WHO; and
- (d) if so, the details of the result of such inspection?

## ANSWER

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

- (a) & (b): World Health Organisation (WHO) from time to time issues various Medical products alert  with  reference  to  products  being  manufactured  in  various  countries.    Recent such Alerts on Indian products are:-
- (i) Four products namely Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup, manufactured by Maiden Pharmaceuticals Limited, Haryana.
- (ii) Two products namely DOK 1 Max syrup and Ambronol Syrup manufactured by M/s. Marion Biotech Pvt. Ltd. Uttar Pradesh.
- (iii) Tetracycline Hydrochloride Ophthalmic Ointment USP 1%, manufactured by Galentic Pharma (India) Pvt. Ltd., Maharashtra.
- (iv) Methotrex  (methotrexate)  50mg,  manufactured  by  Celon  Laboratories,  Pvt.  Ltd., Telangana.
- (c) & (d): Details of investigation are mentioned as under:

A joint investigation was carried out by Central Drugs Standard Control Organisation (CDSCO) in coordination with State Drug Controller, Haryana at M/s Maiden

Pharmaceuticals Limited 81, HSIDC Industrial Area, Kundli 131028, Dist. Sonepat (Haryana) and control samples of the drugs were drawn and sent for test and analysis to Regional Drug Testing Laboratory, (RDTL) Chandigarh.  As per report of the Government Analyst of RDTL Chandigarh, the samples were declared to be of standard quality. The said samples were also found negative for both Diethylene Glycol (DEG) and Ethylene Glycol (EG).

However, based on violations observed in Good Manufacturing Practices, State Drugs Controller, Haryana issued show cause notice to M/s Maiden Pharma on 7.10.2022. Further, an  order  has  been  issued  to  M/s  Maiden  Pharmaceuticals  Limited,  Sonepat,  Haryana  on 11.10.2022  stopping  all  the  manufacturing  activities  of  M/s  Maiden  Pharmaceuticals  at Sonepat with immediate effect in public interest.

CDSCO in coordination with State Drugs Controller, Uttar Pradesh conducted a joint investigation at M/s. Marion Biotech Pvt. Ltd. B-49, Sector 67, Gautam Budh Nagar, Noida201301  (U.P.).  Drug  samples  were  drawn  from  the  manufacturing  premises  under  the provisions  of  Drugs  &  Cosmetics  Act,  1940  for  test  &  analysis.  Further,  manufacturing license  of  the  firm  has  been  suspended  by  State  Licensing  Authority,  Uttar  Pradesh  on 09.01.2023.

In cases of other drugs, the matters are referred to concerned Zonal/subzonal office of CDSCO and investigated in coordination with the State Licensing Authorities (SLAs). Based on  the  investigations,  SLAs  take  suitable  action  under  the  provisions  of  the  Drugs  and Cosmetics Act, 1940.

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