Lok Sabha Question No. 3648 (UNSTARRED), answered on 2026-03-13
Subject: Sale of Spurious Drugs
Ministry: CHEMICALS AND FERTILIZERS
Asked by: Smt. Lovely Anand

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

LOK SABHA UNSTARRED QUESTION No. 3648 TO BE ANSWERED ON THE 13 TH  MARCH 2026

## Sale of Spurious Drugs

## †3648. Smt. Lovely Anand:

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

- (a) whether spurious drugs are openly available in the market across the country, if so, the details thereof;
- (b) whether it is a fact that the Central Drugs Standard Control Organization (CDSCO) has recently  found  deficiencies  in  approximately  53  drug  samples  during  testing  and  declared them as 'Not of Standard Quality', if so, the details thereof;
- (c) whether any action has been initiated against the manufacturers of the said drugs, if so, the details thereof;
- (d) whether it is also a fact that absence of stringent action against erring drug manufacturers encourages similar violations by others; and
- (e) if so, the details thereof?

## ANSWER

## THE MINISTER OF STATE IN THE MINISTRY  OF  CHEMICALS  AND FERTILIZERS

## (SMT. ANUPRIYA PATEL)

- (a):  As  per  the  information  provided  by  Department  of  Health  and  Family  Welfare manufacture/sales/distribution of Spurious/ Adulterated/Not of Standard Quality drugs etc. is a punishable offence under the Drugs & Cosmetics Act, 1940 and the Drugs Rules, 1945 and concerned licensing authorities are empowered to take action in such cases.
- (b)  to  (e):  As  per  the  information  provided  by  Department  of  Health  and  Family  Welfare, Central  Drugs  Standard  Control  Organization  (CDSCO)  as  well  as  State  Drugs  Control Authorities  draw  samples  of  drugs  for  test  and  analysis  from  supply  chain  under  the provisions  of  Drugs  and  Cosmetics  Act,  1940  and  Rules  thereunder.  All  the  drug  samples found  not  of  standard  quality/spurious/  adulterated  by  the  Central  Govt.  Laboratory  and reports of Not of Standard Quality (NSQ)/spurious /adulterated forwarded by the State Drugs Controllers to CDSCO are uploaded on the website of CDSCO as part of the monthly drug alerts to make it available publicly.

In  such cases, the manufacturers (as per the label claim) are directed to recall such drugs  and  based  on  investigation  outcomes,  actions  are  taken  by  the  concerned  licensing authorities under the provisions of Drugs & Cosmetics Act & rules made thereunder.

The number of drugs banned by Central Government under the provisions of Drugs & Cosmetics Act, year wise is as follows:

|   Year | No. of Drugs Banned                          |
|--------|----------------------------------------------|
|   2021 | NIL                                          |
|   2022 | NIL                                          |
|   2023 | 14 for human use and 02 drugs for animal use |
|   2024 | 157 for human use and 01 drug for animal use |
|   2025 | 01 human use and 36 drugs for animal use     |

Further,  under  the  Drugs  and  Cosmetics  Act,  1940,  the  manufacture,  sale,  or distribution  of  spurious  drugs  is  strictly  prohibited.  According  to  Section  17B,  a  drug  is considered  spurious  if  it  is  manufactured  under  the  name  of  another  drug,  is  an  imitation intended  to  deceive,  bears  a  false  manufacturer's  name,  claims  to  be  produced  by  a  non -existent  manufacturer,  or  has  been  wholly  or  partly  substituted  with  another  substance. Section  18  prohibits  the  manufacture,  sale,  stocking,  or  distribution  of  such  drugs  without proper  authorization.  The  Drugs  and  Cosmetics  Rules,  1945  support  these  provisions  by regulating licensing, labeling,  inspection,  and  manufacturing  standards  to  prevent  the production of counterfeit medicines.

Punishment for manufacturing or selling spurious drugs is provided under Section 27 of  the  Act.  If  the  spurious  drug  causes  death  or  grievous  hurt,  the  offender  may  face imprisonment of not less than 10 years, which may extend to life imprisonment, along with a fine of at least ₹10 lakh or three times the value of the drugs confiscated. In other cases, the punishment  includes  imprisonment  of  not  less  than  7  years,  which  may  extend  to  life imprisonment, along with a minimum fine of ₹3 lakh or three times the value of the drugs. Additionally, under Sections 31 and 34, the drugs and related materials may be confiscated, and company officials responsible for the offence may also be held liable. Offences relating to  spurious  drugs  are  cognizable  and  non-bailable,  ensuring  strict  enforcement  against manufacturers of fake medicines.

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