Lok Sabha Question No. 2141 (UNSTARRED), answered on 2022-07-29
Subject: Fake/Spurious Drugs
Ministry: HEALTH AND FAMILY WELFARE
Asked by: Sambhajirao Mane Dhairyasheel, Lavu Sri Krishna Devarayalu, Ravi Kishan Shukla, Ravindra Kushawaha, Prataprao  Jadhav, Sudheer Gupta, Shrirang Appa Barne, Sanjay Sadashivrao Mandlik, Bidyut Baran Mahato

## GOVERNMENT OF INDIA MINISTRY OF HEALTH AND FAMILY WELFARE

## DEPARTMENT OF HEALTH AND FAMILY WELFARE

## LOK SABHA UNSTARRED QUESTION NO. 2141 TO BE ANSWERED ON 29 th  JULY, 2022

## FAKE/SPURIOUS DRUGS

2141:

SHRI DHAIRYASHEEL SAMBHAJIRAO MANE:

SHRI LAVU SRI KRISHNA DEVARAYALU:

SHRI RAVI KISHAN:

SHRI RAVINDRA KUSHWAHA:

SHRI PRATAPRAO JADHAV:

SHRI SUDHEER GUPTA:

SHRI SHRIRANG APPA BARNE:

SHRI SANJAY SADASHIVRAO MANDLIK:

SHRI BIDYUT BARAN MAHATO:

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

- (a) whether the Government is aware of the fact that the business of fake/spurious drugs is spreading throughout the market in the country without any intervention and if so, the details thereof;
- (b)  whether  there  is  a  network  of  manufacturing  and  sale  of  spurious  drugs/medicines  in various parts of the country;
- (c) if so, the details thereof and the action taken by the Government to check the same;
- (d) whether the non-existence of manufacturing plant(s) of pharma companies could be one of the reasons for spread of spurious drug and its manufacturing across the country;
- (e)  whether  the  Government  has  received  any  complaints  regarding  the  sale  of  spurious medicines across the country; and
- (f) if so, the details thereof and the action taken by the Government to check the same?

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

(a) to (f) : The manufacture, 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 respective State Governments. The SLAs are legally empowered to take action in case of violation of the condition of Licence.

The  Government  has  taken  measures  including  strengthening  of  legal  provisions, workshops and training programmes for manufacturers and regulatory officials and measures such as risk based inspection. As per the information received from various State/UTs Drugs Controllers, the enforcement actions carried out in terms of samples tested, number of drugs samples  declared  sub-standard  and  spurious/  adulterated  during  the  last  three  years  are  as below:

| Year   | No. of drugs samples tested   |   No. of drugs samples declared not of standard quality | No. of drugs samples declared spurious/ adulterated   | No. of prosecutions   | No. of persons arrested   |
|--------|-------------------------------|---------------------------------------------------------|-------------------------------------------------------|-----------------------|---------------------------|
| 79,604 | 2,549                         |                                                     205 | 484                                                   | 153                   | 2018-19                   |
| 81329  | 2497                          |                                                     199 | 421                                                   | 220                   | 2019-20                   |
| 84874  | 2652                          |                                                     263 |                                                       | 236 164               | 2020-21                   |

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