Lok Sabha Question No. 2879 (UNSTARRED), answered on 2023-03-17
Subject: Quality of Drugs
Ministry: HEALTH AND FAMILY WELFARE
Asked by: Anto  Antony, Adoor Prakash

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

## LOK SABHA UNSTARRED QUESTION NO.2879 TO BE ANSWERED ON 17 TH  MARCH, 2023

## QUALITY OF DRUGS

## 2879: SHRI ANTO ANTONY: ADV. ADOOR PRAKASH:

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

(a) whether the Government has taken action against the drug manufacturers involved in the recent controversy over the deaths caused by the quality of drugs in different countries, if so, the details thereof;

- (b) whether the Government is planning to centralize drug regulation in the country and if so, the details thereof;
- (c) the details of the strategy to make drug regulations more rigorous to prevent additional deaths caused by Indian exports of pharmaceuticals; and

(d)  the  steps  taken  by  the  Government  to  harmonize  Indian  drug  manufacturing  standards with international standards?

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

(a): 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.

Central  Drugs  Standard  Control  Organisation  (CDSCO)  in  coordination  with  State Drugs Controller, Uttar Pradesh conducted a joint investigation at M/s. Marion Biotech Pvt. Ltd., Noida, Uttar Pradesh. 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.

(b) to (d): 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. Manufacturers are required to comply with the conditions of  Licence  granted  under  the  said  Act  and  Rules  to  manufacture  any  drugs  for  sale  and distribution in the country. The cases concerning quality or safety of drugs when reported, the matter  is  taken  up  with  the  concerned  State  Licensing  Authority  (SLA)  in  order  to  take necessary action under the provisions of Drugs and Cosmetics Act 1940 and its Rules. The SLAs are legally  empowered to take action of violation of any  conditions of such licenses including prosecution in appropriate Court of law.

CDSCO and Ministry of Health and Family Welfare have taken following regulatory measures to ensure the quality of medicines in the country:-

1. The Drugs and Cosmetics Act, 1940 was amended under Drugs &  Cosmetics (Amendment)  Act  2008  to  provide  stringent  penalties  for  manufacture  of  spurious  and adulterated drugs. Certain offences have also been made cognizable and non-bailable.

2. States/ UTs have set up special Courts for trial of offences under the Drugs and Cosmetics Act for speedy disposal.

3. The number of sanctioned posts in Central Drugs Standard Control Organization (CDSCO) has been significantly increased in last 10 years.

4.  To  ensure  efficacy  of  drugs,  the  Drugs  and  Cosmetics  Rules,  1945  have  been  amended providing  that  applicant  shall  submit  the  result  of  bioequivalence  study  along  with  the application for grant of manufacturing license of oral dosage form of some drugs.

5. The Drugs and Cosmetics Rules, 1945 have been amended making it mandatory that before the grant of manufacturing license, the manufacturing establishment is to be inspected jointly by the Drugs Inspectors of Central Government and State Government.

6. The Drugs and Cosmetics Rules, 1945 have been amended, making it mandatory that the applicants shall submit evidence of stability, safety of excipients etc. to the State Licensing Authority before grant of manufacturing license by the Authority.

Central  regulator  coordinates  activities  of  State  Drug  Control  Organisations  and provides expert advice through the Drugs Consultative Committee (DCC) meetings held with State Drugs Controllers for uniformity in administration of the Drugs and Cosmetics Act.

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