Lok Sabha Question No. 5008 (UNSTARRED), answered on 2023-03-31
Subject: Supply of Substandard Medicines
Ministry: HEALTH AND FAMILY WELFARE
Asked by: Kirti Vardhan Singh

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

## LOK SABHA UNSTARRED QUESTION NO.5008 TO BE ANSWERED ON 31 ST  MARCH, 2023

## SUPPLY OF SUBSTANDARD MEDICINES

5008: SHRI KIRTI VARDHAN SINGH:

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

- (a) whether the Ministry is aware of the fact that 67 medicine batches have failed to qualify a random  drug  sample  test  in  which  the  products  of  several  prominent  pharmaceutical companies like Sun Pharma and Alkem are listed;
- (b) if so, the details thereof;
- (c) the various measures/steps taken by the Government to control such substandard supply of medicines in the market; and
- (d)  the  various  penal  actions  the  Government  has  taken  against  such  pharmaceutical companies during the last three years, State/UT-wise?

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

- (a)  to  (c):  The  list  of  Not  of  Standard  Quality  (NSQ)  drugs  declared  by  Drug  Testing Laboratory  under  Central  Drugs  Standard  Control  Organisation  (CDSCO)  is  available  on official  website  of  CDSCO i.e. www.cdsco.gov.in. The list of such drugs for the month of January, 2023 contains the products of various companies including M/s Sun Pharma and M/s Alkem and may be seen at link given below:

https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download\_fi le\_division.jsp?num\_id=OTg4OQ==

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

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. Serious 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  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.
7. (d): As per information received from various States/UT's Drugs Controllers, number of drug  samples  tested,  number  of  drug  samples  reported  spurious/adulterated,  sub-standard drugs and action taken against the offenders during last three years i.e. 2019-2022 is enclosed as Annexure-I .

****

Annexure-I

Number of samples tested and enforcement actions taken, no. of drug samples reported Not  of  Standard  Quality  /spurious  /adulterated  and  enforcement  action  taken  by States/UTs Drugs Controller since last three years is as below:

| Year (1 st April of preceding year to 31 st March of following year)   |   No. of drugs samples tested |   No. of drugs samples declared not of standard quality |   No. of drugs samples declared spurious/ adulterated |   No. of prosecution launched for manufacturing, sale and distribution of spurious/ adulterated drugs |
|------------------------------------------------------------------------|-------------------------------|---------------------------------------------------------|-------------------------------------------------------|-------------------------------------------------------------------------------------------------------|
| 2019-20                                                                |                         81329 |                                                    2497 |                                                   199 |                                                                                                   421 |
| 2020-21                                                                |                         84874 |                                                    2652 |                                                   263 |                                                                                                   236 |
| 2021-22                                                                |                         88844 |                                                    2545 |                                                   379 |                                                                                                   592 |