Lok Sabha Question No. 180 (STARRED), answered on 2024-08-02
Subject: Pharmaceutical Companies in MSME Sector
Ministry: CHEMICALS AND FERTILIZERS
Asked by: Shri Arvind Ganpat Sawant, Shri Sanjay Haribhau Jadhav

## GOVERNMENT OF INDIA MINISTRY OF CHEMICALS AND FERTILIZERS DEPARTMENT OF PHARMACEUTICALS

LOK SABHA STARRED QUESTION No. 180 TO BE ANSWERED ON THE 02 ND  AUGUST, 2024

## Pharmaceutical Companies in MSME Sector

†*180  Shri Sanjay Haribhau Jadhav: Shri Arvind Ganpat Sawant:

Will the Minister of CHEMICALS AND FERTILIZERS be pleased to state:

- (a) whether the Government has taken note that a large number of pharmaceutical companies in Micro, Small and Medium Enterprises (MSME) sector have manufactured such drugs which have been identified as falling under 'Not of Standard Quality' (NSQ) criteria during risk based inspections of pharma companies conducted since December of the previous year;
- (b) if so, the details thereof alongwith the reaction of the Government thereto;

(c)  the  action  taken/proposed  to  be  taken  by  the  Government  against  the  manufacturers  of spurious drugs in the country;

(d) whether the drug regulator of the country had earlier pointed out the urgent need to review the  present  Good  Manufacturing  Practices  (GMP)  regulations  and  Quality  Management System (QMS) being followed by pharma companies; and

(e) if so, the details thereof and the reaction of the Government thereto alongwith the action taken/proposed to be taken to review the present GMP regulations and QMS?

## ANSWER

## THE MINISTER FOR CHEMICALS AND FERTILIZERS & HEALTH AND FAMILY WELFARE

(SHRI JAGAT PRAKASH NADDA)

(a) to (e):        A statement is laid on the Table of the House.

## STATEMENT  REFERRED  TO  IN  REPLY  TO  PARTS  (a)  TO  (e)  OF  STARRED QUESTION NO. 180 FOR REPLY ON 02.08.2024

(a) to (b):    In order to assess the regulatory compliance of drug manufacturing premises in the country, the Central Drugs Standard Control Organization along with State Drugs Controllers (SDCs) have conducted risk-based inspections of 400 premises including MSMEs. The firms have been identified based on risk criteria like number of drugs declared as Not of Standard Quality,  complaints,  criticality  of  the  products  etc.  During  the  inspection  number  of  drug samples  were  drawn  and  tested.  Certain  samples  have  been  found  to  be  'not  of  standard quality'. Based on findings of inspectors, more than 300 actions like issuance of show cause notices, stop production order, suspension, cancellation of licenses /product licenses etc., have been taken by the State Licensing Authorities as per the provisions of the Drugs Rules 1945.

(c): Under the Drug and Cosmetics Act 1940 and the Rules framed thereunder, the regulatory control over the manufacture and sale of the drugs is exercised through a system of licensing and  inspection  by  the  State  Licensing  Authorities  appointed  by  the  State  Governments. Licensee is required to comply with all the conditions of license including Good manufacturing practices  (GMP)  as  prescribed  under  Drugs  Rules,  1945.  State  Licensing  Authorities  are empowered to take action on 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:-

- (i). 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.
- (ii). States/ UTs have set up special Courts for speedy trial of offences under the Drugs and Cosmetics Act.
- (iii). The number of sanctioned posts in CDSCO has been significantly increased in last 10 years.
- (iv). 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.
- (v). 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  the  Central  Government  and  the  State Government.
- (vi). 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.
- (vii). Central regulator coordinates activities of State Drug Control Organisations and provides expert advice through the Drugs Consultative Committee meetings held with State Drugs Controllers for uniformity in administration of the Drugs and Cosmetics Act.

(d) & (e): Under the Drug and Cosmetics Act 1940 and rules framed thereunder, the regulatory control over the manufacture and sale of the drugs is exercised through a system of licensing and  inspection  by  the  State  Licensing  Authorities  appointed  by  the  State  Governments. Licensee is required to comply with the conditions of license including Good manufacturing practices  (GMP)  as  prescribed  under  Drugs  Rules,  1945.  State  Licensing  Authorities  are empowered to take action on violation of any conditions of such licenses including prosecution in appropriate Court of Law. As per the Drugs Rules, 1945 the manufacturing premises whether they are MSME or otherwise, are required to comply with the conditions of license including the Good manufacturing practices (GMP) as prescribed under the Schedule M of the Drugs Rules, 1945. Central Government has amended the Drugs Rules 1945 vide G.S.R. 922 (E) dated 28.12.2023 to revise the Schedule M to the said rules related to Good Manufacturing Practices  and  requirements  of  premises,  plant  and  equipment  for  pharmaceutical  products under Schedule M. Quality Management System (QMS) has also been prescribed in the revised schedule M.

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