Lok Sabha Question No. 3900 (UNSTARRED), answered on 2015-12-22
Subject: Sale of Oxytocin
Ministry: CHEMICALS AND FERTILIZERS
Asked by: T. RADHAKRISHNAN, RAJEEV SHANKARRAO SATAV, SUPRIYA SADANAND SULE, HEENA VIJAYKUMAR GAVIT, DHANANJAY BHIMRAO MAHADIK, JAYAKUMAR JAYAVARDHAN

## GOVERNMENT OF INDIA MINISTRY OF CHEMICALS AND FERTILIZERS DEPARTMENT OF PHARMACEUTICALS

## LOK SABHA

## UNSTARRED QUESTION No. 3900

## TO BE ANSWERED ON THE 22 nd  December, 2015

## Sale of Oxytocin

3900. SHRI T. RADHAKRISHNAN:

SHRI SATAV RAJEEV: SHRIMATI SUPRIYA SULE: DR. HEENA VIJAYKUMAR GAVIT: SHRI DHANANJAY MAHADIK: DR. J. JAYAVARDHAN:

Will the Minister of CHEMICALS AND FERTILIZERS be pleased to state:

- (a) whether the retail sale of Oxytocin which was banned last year by the Government has been illegally continuing in the market, if so, the details thereof;
- (b) whether Drug Controller General of India (DCGI) has conducted countrywide raid in this regard, if so,  the quantum of Oxytocin confiscated by DCG;
- (c) whether the DCGI has asked State Drug Controllers to provide information regarding licences issued for the manufacture of bulk oxytocin  formulation,  if  so,  the  details  thereof  along  with  the objective behind the move; and
- (d) whether oxytocin is also smuggled from China which is available at cheaper rate, if so, the corrective steps taken/being taken by the  Government  for  implementation  of  ban  on  the  use  of Oxytocin in the country?

## ANSWER

## MINISTER  OF  STATE  IN  THE  MINISTRY  OF  CHEMICALS  AND FERTILIZERS (SHRI HANSRAJ GANGARAM AHIR)

(a): There is no ban on the sale of oxytocin in the country for permitted use  of  the  drug.  However  to  prevent  misuse  of  oxytocin  the  measures have been taken by government:

-  Drug  is  permitted  to  be  manufactured  and  sold  in  single  unit blister pack only.
-  Government  of  India  under  section  26A  of  the  Drugs  and Cosmetics Act, 1940 (23 of 1940), has issued a notification vide

GSR no. 29 (E) dated 17/01/2014, to regulate and restrict the manufacture,  sale  and  distribution  of  Oxytocin  in  the  country and to prevent its misuse, directing that the drug Oxytocin shall be  manufactured  for  sale  or  for  distribution  or  sold  in  the manner specified below:-

1. The  manufacturers  of  bulk  oxytocin  drug  shall  supply  the active pharmaceutical drug only to the manufacturers licensed  under  the  Drugs  and  Cosmetics  Rules,  1945  for manufacture of formulations of the said drug.
2. The formulations meant for veterinary use shall be sold to the veterinary hospitals only.

(b) to (d):  Various  Zonal  Sub  Zonal  offices  under  DCG  (I)  conduct investigation/raids from time to time based on complaint/surveillance etc. relating to manufacture, sale, distribution of drugs including Oxytocin. However, DCG (I) on 06 October 2015 deputed 8 teams of CDSCO officers including independent experts to conduct investigation at various ports to undertake  investigation  of  the  import,  export,  domestic  supplies,  raw material and finished bulk of oxytocin supplied to formulation manufacturers etc. While the teams have conducted the investigation no raid/seizure have been done.

Further  based  on  information  that  Oxytocin  was  allegedly  being imported  under  the  name  of  Custom  Peptide  through  courier  company, different teams comprising senior officers of CDSCO were constituted by DCG (I) recently in October 2015 to further investigate the matter. The teams had conducted raids in Delhi, Kolkata, Ludhiana & Patna and seized 1.7 Kg of oxytocin being illegally imported from China under the name of custom peptide.

To  keep  vigil  on  illegal  movement  of  oxytocin  and  take  action thereof, DCG (I) on 22/10/2014 had written to the State Drugs controllers to provide information of manufacturers of bulk & formulation of oxytocin in their states along with details of seizures, raids conducted etc..

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