Lok Sabha Question No. 37 (STARRED), answered on 2023-02-03
Subject: Spurious Drugs
Ministry: HEALTH AND FAMILY WELFARE
Asked by: Rajiv Ranjan (Lalan) Singh, Santosh Kumar

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

## LOK SABHA STARRED QUESTION NO. 37

## TO BE ANSWERED ON THE 3 RD  FEBRUARY, 2023

## SPURIOUS DRUGS

## †*37. SHRI RAJIV RANJAN SINGH ALIAS LALAN SINGH:

## SHRI SANTOSH KUMAR:

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

- (a) whether the sale of spurious drugs in the market has become rampant these days,
- if so the details thereof;
- (b) whether spurious/fake drugs are being sold/ made available in the market even for serious diseases like cancer;
- (c) if so, the details thereof and the reaction of the Government thereon; and
- (d)  the  steps  taken/being  taken  by  the  Government  to  put  a  complete  ban  on availability and sale of such spurious drugs?

## ANSWER THE MINISTER OF HEALTH AND FAMILY WELFARE (DR MANSUKH MANDAVIYA)

(a) to (  d) A Statement is laid on the Table of the House.

## STATEMENT REFERRED TO IN REPLY TO LOK SABHA STARRED QUESTION NO. 37 FOR 3 RD  FEBRUARY, 2023

(a) to (d): Isolated  complaints  regarding  spurious  drugs  are  received  in  Central Drugs Standard Control Organisation (CDSCO). As and when such complaints are received, based on merit, the matter is taken up by the CDSCO in coordination with State/UT  Drugs  Controller  for  action  as  per  the  provisions  of  the  Drugs  & Cosmetics Act, 1940 and the Drugs & Cosmetics Rules, 1945. As per information received  from  CDSCO,  the  details  of  drugs  sample  tested  and  declared  Not  of Standard Quality/ spurious/ adulterated drugs during the last three years is annexed .

Upon  receipt  of  complaints  regarding  quality  of  medicines,  CDSCO  in coordination  with  State  Licensing  Authority  takes  action  as  per  the  provisions  of Drugs & Cosmetics Act and Rules.

The Government has taken various regulatory measures to ensure the quality of  medicines in  the  country.  These  includes  notification  for  affixing  Bar  Code  or Quick Response Code in Active Pharmaceutical Ingredients (APIs) and some drug formulations,  increase  in  sanctioned  regulatory  posts  of  CDSCO  and  notification providing marketers of any drug to be responsible for its quality.

Further,  testing  capacities  of  Central  Drugs  Testing  Laboratories  under CDSCO  have  been  strengthened,  and  Drugs  and  Cosmetics  Rules,  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  product manufacturing license by the Authority, and that applicant shall submit the result of bioequivalence study along with the application for grant of manufacturing license of oral dosage form of drugs falling under the Category II and Category IV of the Biopharmaceutical Classification System.

The Central Government has provided Rs. 651.97 crores for strengthening the drug regulatory system including upgradation of existing State laboratories, setting up of new drug testing laboratories and upgradation of existing State drug control offices as part of 'Strengthening of State Drug Regulatory System'.

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Annexure Number  of  samples  tested  and  no.  of  drug  samples  reported  Not  of  Standard  Quality

## /spurious /adulterated by States/UTs Drugs Controller during last three years is as below:

|         | By States/UTs Drugs Controller   | By States/UTs Drugs Controller                        | By States/UTs Drugs Controller                      | By Zonal/Sub-zonal offices of CDSCO   | By Zonal/Sub-zonal offices of CDSCO                   | By Zonal/Sub-zonal offices of CDSCO                 |
|---------|----------------------------------|-------------------------------------------------------|-----------------------------------------------------|---------------------------------------|-------------------------------------------------------|-----------------------------------------------------|
| Year    | No. of drugs samples tested      | No. of drugs samples declared not of standard quality | No. of drugs samples declared spurious/ adulterated | No. of drugs samples tested           | No. of drugs samples declared not of standard quality | No. of drugs samples declared spurious/ adulterated |
| 2019-20 | 81329                            | 2497                                                  | 199                                                 | 9299                                  | 307                                                   | 12                                                  |
| 2020-21 | 84874                            | 2652                                                  | 263                                                 | 5460                                  | 170                                                   | 3                                                   |
| 2021-22 | 88844                            | 2545                                                  | 379                                                 | 7036                                  | 287                                                   | 2                                                   |

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