Lok Sabha Question No. 735 (UNSTARRED), answered on 2021-07-23
Subject: Banned/Unapproved Drugs
Ministry: HEALTH AND FAMILY WELFARE
Asked by: Sarmistha Sethi

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

## LOK  SABHA UNSTARRED QUESTION NO. 735 TO BE ANSWERED ON 23 RD JULY, 2021

## BANNED/UNAPPROVED DR UGS

## 735. SHRIMATI SARMISTHA SETHI:

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

- (a) whether certain cases of manufacturing and marketing of banned/ unapproved drugs have beenreported in the country;
- (b) if so, the details thereof indicating the number of such cases reported during each of the last three years and the current year, State/UT - wise;
- (c) the action taken against the offenders during the said period, State/UT -wise;
- (d)  whether  the  Government  proposes  to  put  in lace  a  comprehensive  mechanism  to  stop manufacturing and marketing of banned/unapproved drugs across the country; and
- (e) if so, the details thereof?

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

(a) to (c): A few cases of grant of manufacturing license of new drugs including Fixed Dose Combinations (FDCs) falling under the purview of Rule 122E of the Drugs & Cosmetics Rule 1945  by  some  of  the  State  Licensing  Authorities  (SLAs)  without  due  approval  of  the  Dr Controller General (India) [DCG (I)] came to the notice of the Government.

44 cases of unapproved FDCs licensed by State Licensing Authorities (SLAs) considered new Drugs, have been reported during the year 2018 to 2021 (till date). In all such ca office of DCGI took up the matter with respective SLAs for necessary action. The State/UT - wise and year wise details of these 44 cases is annexed. Further, the state Drugs Controllers have also been requested from time to time in the Drug Consultative Committee meetings to en that ne w drugs and FDC are not permitted without approval from the office of DCGI.

- (d) & (e): Manufacture,  sale  and  distribution  of  prohibited/banned  drugs  is  a  punisha offence  under  section  18  of  the  Drugs  and  Cosmetics  Act.  State  Licensing  Authorities empowered to take action in this regard .

ANNEXURE

| Name of the State   |   No. of FDCs for which licenses were granted by SLAs without new drug permission from DCG(I) |
|---------------------|-----------------------------------------------------------------------------------------------|
| Uttarakhand         |                                                                                            10 |
| Maharashtra         |                                                                                            07 |
| Daman & Diu         |                                                                                             3 |
| Himachal Pradesh    |                                                                                             4 |
| Tamilnadu           |                                                                                             1 |
| West Bengal         |                                                                                             1 |
| Karnataka           |                                                                                             2 |
| Gujarat             |                                                                                             3 |
| Sikkim              |                                                                                             6 |
| Jammu               |                                                                                             1 |
| Uttar Pradesh       |                                                                                             3 |
| Bihar               |                                                                                             1 |
| Telangana           |                                                                                             2 |
| Total               |                                                                                            44 |

Year wise details

| Year   |   Number of cases |
|--------|-------------------|
| 2018   |                08 |
| 2019   |                17 |
| 2020   |                14 |
| 2021   |                 5 |
| Total  |                44 |