$~31 to 33

* IN THE HIGH COURT OF DELHI AT NEW DELHI

+ W.P.(C) 6084/2018, C.M. APPL.23517/2018
BGP PROUDUCTS OPERATIONS GMBH AND ANR. ..... Petitioners
versus
UNION OF INDIA AND ORS. ..... Respondents
+ W.P.(C) 8555/2018, C.M. APPL.32864/2018 & 34112/2018
ALL INDIA DRUG ACTION NETWORK ..... Petitioner
versus
UNION OF INDIA & ANR ..... Respondents
+ W.P.(C) 8666/2018, C.M. APPL.33281/2018
NEON LABORATORIES LTD ..... Petitioner
versus
UNION OF INDIA & ORS ..... Respondents
Through : Sh. Jayant Bhushan, Sr. Advocate with Ms.
Gayatri Roy, Ms. Soumili Das and Sh. Amit Panigrahi,
Advocates, for Petitioner Nos. 1 and 2 in Item No.31.
Ms. Maninder Acharya, ASG with Sh. Ripu Daman
Bhardwaj, CGSC, Sh. Kirtiman Singh, CGSC, Sh.
Rishikant Singh, Sh. Waize Ali Noor, Sh. Prateek Dhanda,
Ms. Shruti Dutt, Sh. Harshul Choudhary, Sh. Sahil Sood
and Sh. Viplav Acharya, Advocates, for UOI, in Item Nos.
31.
Ms. Maninder Acharya, ASG with Sh. Kirtiman Singh,
CGSC Sh. Ripu Daman Bhardwaj, CGSC, Sh. Kirtiman
Singh, CGSC, Sh. Rishikant Singh, Sh. Waize Ali Noor,
Sh. Prateek Dhanda, Ms. Shruti Dutt, Sh. Harshul
Choudhary, Sh. Sahil Sood and Sh. Viplav Acharya,
Advocates, for UOI, in Item Nos. 31.
Sh. Ashish Prasad, Ms. Mukta Dutta and Sh. Rohan Roy,
Advocates, for respondent, in Item No.31.
Sh. Colin Gonsalves, Sr. Advocate with Ms. Mohana
Sriwastava and Sh. Deepak Kumar Singh, Advocates, for
petitioner, in Item No.32.
Sh. Ravikesh. K. Sinha, Advocate, for petitioner, in Item
No.33.

W.P.(C) 6084/2018 and connected matters Page 1 of 8

CORAM:
HON'BLE MR. JUSTICE S. RAVINDRA BHAT
HON'BLE MR. JUSTICE A. K. CHAWLA

ORDER
% 31.08.2018

This Court has heard the writ petitions on the past two dates,
i.e. on 29.08.2018 and 30.08.2018.

These petitions impugn the notification dated 27.04.2018 issued

by the Central Government under 26A of the Drugs and Cosmetics
Act, 1940 [hereafter “the Act”], restricting domestic sales by
manufacturers licensed to produce the drug containing the Active
Pharmaceutical Ingredient (API) Oxytocin. It is contended inter alia
that the impugned notifications, to the extent they restrict and regulate
the manufacture and sale – in the domestic market of the product by
the public sector units, is arbitrary and unreasonable. The petitioners
rely upon several materials in support of the claim.

It is contended broadly that there are 112 drug manufacturers

who cater to the needs of the general populace. The formulations of
Oxytocin are used generally to stem post-partum hemorrhage in
pregnant women. The petitioners cite World Health Organization
(WHO) and other international and other official reports, flagging and
highlighting the necessity of ubiquitous use of Oxytocin formulations
to prevent excessive usage. Apparently, it is also used in the
veterinary sector for similar purposes. One of the prominent abuses of

W.P.(C) 6084/2018 and connected matters Page 2 of 8

Oxytocin is in the dairy sector where it is injected for enhancing
lactation in bovine creatures – cows, buffaloes etc. The petitions
highlight the concerns, various deliberations and minutes of meetings
of the Drugs Consultative Committee (DCC) and the Drugs Technical
Advisory Board (DTAB) constituted under Section 5 of the Act. The
petitioners in this regard rely upon the 44 th, 46th and 49th meeting of
the DCC and minutes of meetings dated 20.07.2012, 12/13.11.2013
and 16.10.2015. These meetings highlighted the veterinary misuse of
the drug; in one of these apparently, the concerned Minister for
Women and Child Development was also present. Her remarks
flagged the concerns with respect to the misuse of Oxytocin in
veterinary sector. The petitioners rely upon the minutes of meeting of
the DTAB, particularly, the 65th meeting dated 25.11.2013; the 67th
meeting dated 01.04.2014; the 69th meeting dated 22.04.2015; the 70th
meeting dated 18.08.2015 and the 78th meeting dated 12.02.2018.
Various measures were outlined; these included ban for veterinary use
and that the bulk drug Oxytocin should be sold to manufacturers
licensed for this purpose only, that the sale and supply in the
veterinary sector should be restricted to veterinary hospitals of such
products and that the Government should consider banning of imports
of Oxytocin into India. At the same time, the DCC and the DTAB
underlined the therapeutic use of Oxytocin in the medical sector
keeping in mind the high percentage of maternal mortality (according
to some report, it was as high as 45,000 a year). The other measures

W.P.(C) 6084/2018 and connected matters Page 3 of 8

suggested included increased surveillance and enforcement action by
prosecutions, seizures, increased investigations into the illicit use of
Oxytocin etc.

The outcomes of these deliberations of the DCC and the DTAB

were apparently that on 17.01.2014 a notification was issued by the
Central Government under Section 26A of the Act, restricting the
supply of the bulk drug Oxytocin to licensed manufacturers that were
entitled to produce the formulation in its dispensable form (injectable
ampoules etc).

The notification also directed that formulations meant for

veterinary use ought to be restricted for sale in veterinary hospitals. It
is submitted by the petitioners that in the background of these
circumstances, the sudden and abrupt issuance of the impugned
notification dated 27.04.2018 is arbitrary; it is also urged that it was
without application of mind to the reports of these expert bodies. The
petitioners cited UOI v. Pfizer Ltd. 2018 (2) SCC 39 in support of
their contention that the Central Government, though not obliged to
consult the DCC and the DTAB before taking any measure, has to
nevertheless take into account the recommendations of these bodies. It
is also urged that the subsequent action of the Central Government, to
restrict the manufacture and take-over the supply, generally, of
Oxytocin for domestic use through the public sector unit KAPL is
highly inadequate. It is submitted that the subsequent action by way of
notification of 21.08.2018, relieving to some extent the more

W.P.(C) 6084/2018 and connected matters Page 4 of 8

restrictive operations of the impugned notification, and permitting
other than its exclusive distributors to sell the product, raises more
concerns than addresses them.

The Central Government has filed its response in the form of

affidavits, in two of these proceedings. It is urged on its behalf by Ms.
Maninder Acharya, learned ASG, who also produced the relevant
records, that the question of regulating the domestic sale of Oxytocin
was always under active consideration by the Central Government at
the highest levels. Firstly, she relied upon the minutes of meeting held
on 26.09.2015 which involved the participation of Secretaries of all
Departments concerned. It was submitted that these meeting had
considered through power point presentations, the concerns which had
been flagged by the DCC and the DTAB. The Central Government
also relies upon the minutes of another subsequent meeting held on
08.02.2018, where again the Department heads by way of Secretaries
of some Ministries were present. It was submitted that in this meeting,
the intervening development by way of Himachal Pradesh High
Court’s direction contained in one of its judgments delivered on
15.03.2016 [Court on its own motion v. State of Himachal Pradesh
and Ors., CWPIL No.16/2014] – suggesting that one of the ways of
controlling misuse in the veterinary sector of Oxytocin would be by
channelizing the domestic sale through public sector units - was
considered. It was submitted that these meetings also considered the
DCC deliberations in its 46th meeting besides all other relevant

W.P.(C) 6084/2018 and connected matters Page 5 of 8

material, including the DTAB/DCC deliberations and minutes of
meetings; this led to a decision by the Central Government to take
measures towards restricting the sale of Oxytocin and channelizing
the drug through the public sector.

Since the Court was concerned with the capacity of KAPL

amongst other issues, the learned ASG also sought to address these
concerns by producing the statistics with respect to the production
figures of KAPL vis-à-vis Oxytocin formulations. The parties agree
that the birth rate in India is 20.4 per thousand (in 2017-18) according
to the figures relied upon – i.e. 20782247 child births. Against this,
the total production capacity hitherto existing was 6 crore ampoules
per annum. It is stated that KAPL is geared to cater to that possibility
and has the capacity to manufacture 51 lakh ampoules per month
which would meet the complete demand.

The Court had the benefit of the perusal of the official files.
The Counter Affidavit of the Union has also relied upon the
DCC/DTAB deliberations. Each one of the reports and minutes do
suggest that concerns existed with respect to the perceived and
observed abuse of the drug Oxytocin in the veterinary sector. The
Counter Affidavit has highlighted that in the past 3-4 years,
insistences of seizures on account of illegal sales of Oxytocin and
their use in the veterinary sector has been pursued. In this regard, a
chart has been produced along with the details of prosecutions
launched. According to the materials available on record with this

W.P.(C) 6084/2018 and connected matters Page 6 of 8

Court which was also taken into account by the Central Government,
a total of 116 inspections were conducted which resulted in
prosecution in 12 instances. The figures relied upon suggest that the
extreme measure of prohibiting sale of Oxytocin in the domestic
market also bespeak of only two suspensions of licenses from
amongst 112 licensed manufacturers. The details of the seizures
placed on the record predominantly suggest that the abuse is in a
widespread manner in the east of India – Bihar and West Bengal. In
this regard, the concerns of the DTAB and DCC (which are bodies not
only constituted under the Statute but also comprising of experts in
the fields of medicine, veterinary science, medical research,
pharmaceuticals and other sectors) have all emphasized that the
extreme measure of prohibition and restricted sale would not be in
order. The materials disclosed to the Court also show that when the
decision to restrict the domestic sale of Oxytocin was taken in
February 2018, KAPL, as a matter of fact, was not even licensed to
manufacture the drug. The licenses was issued, in this regard, to
KAPL in April 2018.

Taking into account the submissions made so far, the Court

prima facie is of the opinion that a ban or complete prohibition of
domestic sales of Oxytocin, initially put into place on 27.04.2018,
(which sought to bring the prohibition in force with effect from
01.07.2018 and which was later postponed by notification dated
29.06.2018) should be suspected/stayed for one month. It is so

W.P.(C) 6084/2018 and connected matters Page 7 of 8

directed. The petitioners have concluded submissions. The
respondents and other parties may in the meanwhile complete their
submissions and rely upon any other materials that they wish to.

List on 12.09.2018 for further arguments. It is open to the

respondents/UOI to file any further affidavits/pleadings with such
supporting materials as they wish to rely upon, within a week.

Order dasti under the signatures of the Court Master.

S. RAVINDRA BHAT, J

A. K. CHAWLA, J
AUGUST 31, 2018/ajk

W.P.(C) 6084/2018 and connected matters Page 8 of 8