Lok Sabha Question No. 430 (UNSTARRED), answered on 2023-02-03
Subject: Fake Medicinal Drugs
Ministry: HEALTH AND FAMILY WELFARE
Asked by: Gaurav Gogoi

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

## LOK SABHA UNSTARRED QUESTION NO.430 TO BE ANSWERED ON 03 RD  FEBRUARY, 2023

## FAKE MEDICINAL DRUGS

## 430: SHRI GAURAV GOGOI:

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

- (a) the steps taken or proposed to be taken by the Government to prevent the online apps assisting medical practitioners from being misused for obtaining fake prescriptions;
- (b) the year-wise and state-wise details of the seizure of fake medicinal drugs with its name and quantity of seizure, since 2014;
- (c) the year-wise and country-wise details of every instance of a foreign country reporting to India about the seizure of Indian fake medicinal drugs in its country since 2014;
- (d) the country-wise number of deaths occurred in foreign countries due to fake medicinal drugs manufactured in India since 2014; and
- (e) the year-wise and State-wise details of the number of deaths in India due to the consumption of fake Indian drugs since the year 2014?

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

(a) to (e): Ministry  of  Health  and  Family  Welfare  has  notified  Electronic  Health  Records Standards for  India,  2016.  Under  this  standard  it  has  been  mentioned  that  Pharmacy  Council  of India (PCI) vide regulation has provided that the term 'Prescription' includes the term 'electronic direction'.  The  printed  prescription  will  need  to  be  in  the  PCI  prescribed  format  whenever  any medical  prescription  meant  for  drug  dispensing  is  prepared.  For  the  purpose  of  e-  Prescription, implementers  must  ensure  that  the  electronic  version  is  digitally  signed  by  a  registered  medical practitioner, and its non-repudiation is ensured.

As per information received from various States/UTs Drugs Controller, year wise data of Not  of  Standard  Quality/Adulterated/Spurious  Drugs  reported,  seizures  made  and  enforcement action taken thereof, is as follows :

| 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 |   No. of persons arrested | No. of Raids Conducted   |
|------------------------------------------------------------------------|-------------------------------|---------------------------------------------------------|-------------------------------------------------------|-------------------------------------------------------------------------------------------------------|---------------------------|--------------------------|
| 2014-15                                                                | 74199                         | 3702                                                    |                                                    83 |                                                                                                   152 |                        85 | 14042                    |
| 2015-16                                                                | 74,586                        | 3703                                                    |                                                   234 |                                                                                                   289 |                        59 | 3648                     |
| 2016-17                                                                | 76,721                        | 2,780                                                   |                                                   123 |                                                                                                   186 |                       106 | 10,921                   |
| 2017-18                                                                | 82,599                        | 2783                                                    |                                                   236 |                                                                                                   131 |                       163 | 7067                     |
| 2018-19                                                                | 79,604                        | 2,549                                                   |                                                   205 |                                                                                                   484 |                       153 | 33,492                   |
| 2019-20                                                                | 81329                         | 2497                                                    |                                                   199 |                                                                                                   421 |                       220 | 15641                    |
| 2020-21                                                                | 84874                         | 2652                                                    |                                                   263 |                                                                                                   236 |                       164 | 20922                    |
| 2021- 2022                                                             | 88844                         | 2545                                                    |                                                   379 |                                                                                                   592 |                       450 | 15973                    |

Central  Drugs  Standard  Control  Organisation  (CDSCO)  has  informed  that  no  such information  is  available  regarding  seizure  of  fake/spurious  drugs,  manufactured  in  India,  in  a foreign country.

As  informed  by  CDSCO,  no  communication  has  been  received  from  Government  of Gambia that use of the products manufactured by M/s Maiden Pharmaceuticals Limited, Sonipat has led to the death of children in their Country.

However, a communication has been received in Ministry of Health and Family Welfare from the Ministry of Health of the Republic of Uzbekistan informing that the use of the drug 'Doc1 Max' Syrup manufactured by M/s. Marion Biotech Pvt. Ltd, Noida resulted in severe side effects that led to the death of children and upon testing the said drug has revealed presence of Ethylene Glycol and/or Diethylene Glycol.

As  per  information  received  from  States/UTs,  no  case of  death  in  India  due  to  the consumption of fake Indian drugs has been reported since the year 2014.

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