Lok Sabha Question No. 585 (UNSTARRED), answered on 2018-07-20
Subject: Ban on Oxytocin
Ministry: HEALTH AND FAMILY WELFARE
Asked by: SUSHIL KUMAR SINGH, KAVITHA KALVAKUNTLA, SUMEDHANAND SARASWATI

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

## LOK SABHA UNSTARRED QUESTION NO. 585 TO BE ANSWERED ON 20 th JULY, 2018

## BAN ON OXYTOCIN

## 585. SHRI SUSHIL KUMAR SINGH: SHRIMATI KAVITHA KALVAKUNTLA: SHRI SUMEDHANAND SARSWATI:

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

- (a)  whether  the  Government  has  taken a  decision  to  withdraw  the  permission  for production  of Oxytocin injection by the private companies in the country for domesticuse from 1 July, 2018, if so, thedetails thereof;
- (b) whether the Oxytocin drug is commonly used by the Gyneacologists, if so, the details and its present status thereof;
- (c)  whether  Oxytocin  injection  is being  misused  in  d ai ry  and  vegetable industry in  the  country causing adverse impacts body, if so, the punitive measures taken by the Government in this regard; and
- (d) the number of cases of misuse of Oxytocin reported in the country during the last three years and the current year along with action taken against offenders by the Government?

## ANSWER THE MINISTER OF STATE IN THE MINISTRY OF HEALTH AND FAMILY WELFARE (SHRI ASHWINI KUMAR CHOUBEY)

- (a): Government has, vide GSR No.411 (E) dated 27.04.2018, which will be effective from 1s September, 2018 , restricted the manufacture of Oxytocin formulations for domestic use to pu sector only. It has also been stipulated in the said notification that Oxytocin formulations domestic consumption will be supplied by the manufacturers to the regist ered hospitals and clinics in public and private sector directly. Further, Oxytocin in any form or name shall not be sol retail Chemist.
- (b): Oxytocin is used in various Gyneacologic indications.
- (c) & (d): Misuse of Oxytocin has been reported from time to time in various forums including in print and electronic media.

The  manufacture,  sale  and  distribution  of  drugs  in  the  country  are  regulated  unde provisions  of  Drugs  &  Cosmetics  Act,  1940  and  Rules,  1945  thereunder  through  a  syste m  of licensing and inspection. Licenses for manufacture, sale and distribution of drugs are grant State Licensing Authorities (SLAs) appointed by respective State Governments. SLAs are leg empowered to take stringent action against violation o f any provision of the Act and Rules.

The number of cases of misuse of Oxytocin reported in the country during the last three and the current year along with action taken against offenders by States/UTs Drugs Controlle Central  Drugs  S tandard  Control  Organisation  (CDSCO)  is  enclosed  as Annexure  A  and Annexure B respectively .

Details  of  number  of  cases  of  misuse  of  Oxytocin  and  action  taken,  as  received  from  various States/UTs Drugs Controllers are as under:

|   S. No. | State/UTs            | Total number of cases of misuse of oxytocin reported in the country during the last three years and current year   | Action taken against offenders                                                                     |
|----------|----------------------|--------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|
|        1 | Andhra Pradesh       | 6 Cases                                                                                                            | Complaints filed by Govt. of Andhra Pradesh in the Hon'ble Court                                   |
|        2 | Arunachal Pradesh    | Nil                                                                                                                | Nil                                                                                                |
|        3 | Assam                | Nil                                                                                                                | Nil                                                                                                |
|        4 | Bihar                | Data awaited                                                                                                       |                                                                                                    |
|        5 | Goa                  | Nil                                                                                                                | Nil                                                                                                |
|        6 | Gujarat              | Nil                                                                                                                | Nil                                                                                                |
|        7 | Haryana              | Nil                                                                                                                | Nil                                                                                                |
|        8 | Himachal Pradesh     | Nil                                                                                                                | Nil                                                                                                |
|        9 | Jammu & Kashmir      | Nil                                                                                                                | Nil                                                                                                |
|       10 | Karnataka            | 1 Case detected at Belgaum.                                                                                        | Complaint has been lodged by Govt. of Karnataka in the Khade Bazar, Police station, Belgaum Distt. |
|       11 | Kerala               | Nil                                                                                                                | Nil                                                                                                |
|       12 | Madhya Pradesh       | Nil                                                                                                                | Nil                                                                                                |
|       13 | Maharashtra          | Nil                                                                                                                | Nil                                                                                                |
|       14 | Manipur              | Nil                                                                                                                | Nil                                                                                                |
|       15 | Meghalaya            | Nil                                                                                                                | Nil                                                                                                |
|       16 | Mizoram              | Nil                                                                                                                | Nil                                                                                                |
|       17 | Nagaland             | Nil                                                                                                                | Nil                                                                                                |
|       18 | Odisha               | Nil                                                                                                                | Nil                                                                                                |
|       19 | Punjab               | Nil                                                                                                                | Nil                                                                                                |
|       20 | Rajasthan            | Data awaited                                                                                                       |                                                                                                    |
|       21 | Sikkim               | Nil                                                                                                                | Nil                                                                                                |
|       22 | Tamil Nadu           | 4 Cases                                                                                                            | Action as per the provisions of Drugs and Cosmetics Rules, 1945 by Govt. of Tamil Nadu             |
|       23 | Tripura              | Nil                                                                                                                | Nil                                                                                                |
|       24 | Uttar Pradesh        | 11 cases                                                                                                           | FIRs lodged.                                                                                       |
|       25 | West Bengal          | Nil                                                                                                                | Nil                                                                                                |
|       26 | Pondicherry          | Nil                                                                                                                | Nil                                                                                                |
|       27 | Andaman & Nicobar    | Data awaited                                                                                                       |                                                                                                    |
|       28 | Chandigarh           | Nil                                                                                                                | Nil                                                                                                |
|       29 | Delhi                | 1 Case                                                                                                             | Case is under Hon'ble Session Court, Tis Hazari.                                                   |
|       30 | Dadra & Nagar Haveli | Nil                                                                                                                | Nil                                                                                                |
|       31 | Daman & Diu          | Nil                                                                                                                | Nil                                                                                                |
|       32 | Lakshadweep          | Data awaited                                                                                                       |                                                                                                    |
|       33 | Chhattisgarh         | Nil                                                                                                                | Nil                                                                                                |
|       34 | Jharkhand            | 9 Cases                                                                                                            | Prosecution/FIR-09                                                                                 |
|       35 | Uttarakhand          | Nil                                                                                                                | Nil                                                                                                |
|       36 | Telangana            | 7 Cases                                                                                                            | Govt. of Telangana is investigating the cases.                                                     |

Details of number of cases of misuse of Oxytocin and action taken by CDSCO

|   S. No. | Total number of cases of misuse of oxytocin reported in the country during the last three years and current year   | Action taken against offenders                                                                                                  |
|----------|--------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|
|        1 | 3 Cases                                                                                                            | In 2 cases prosecution were filed in the Hon'ble Court of Metropolitan Magistrate Rohini Delhi dated 22/02/2016 and 25/07/2016. |