Delhi High Court
M/S Eurokem Laboratories (P) Ltd. ... vs Ministry Of Health And Family ... on 4 July, 2019
$~25
* IN THE HIGH COURT OF DELHI AT NEW DELHI
+ W.P.(C) 6523/2019 & CM Nos. 27574/2019 & 29518/2019
M/S EUROKEM LABORATORIES (P)
LTD. AND ANR. ..... Petitioners
Through: Ms Amita Gupta, Advocate.
versus
MINISTRY OF HEALTH AND FAMILY
WELFARE AND ANR. ..... Respondents
Through: Mr Kirtiman Singh, Mr Shruti
Dutt, Mr Prateek Dhanda, Mr
Waize Ali Noor, Advocates for
R1.
Mr Rishikant Singh, Advocate
for R2.
6.
+ W.P.(C) 4672/2019
OVERSEAS HEALTH CARE PVT.
LTD ..... Petitioner
Through: Ms Amita Gupta, Advocate.
versus
MINISTRY OF HEALTH & FAMILY WELFARE
& ANR ..... Respondents
Through: Mr Rishi Kant Singh, Advocate
for R2.
CORAM:
HON'BLE MR. JUSTICE VIBHU BAKHRU
W.P. (C) 6523/2019 & 4672/2019 Page 1 of 12
ORDER
% 04.07.2019
VIBHU BAKHRU, J
1. The petitioners are engaged in the business of manufacture and
sale of drugs. They have filed the present petitions being, essentially,
aggrieved by the amendment to the Indian Pharmacopoeia regarding
the standards for Albendazole Tablets as introduced by respondent
no.2 (Indian Pharmacopoeia Commission - hereafter 'the IP
Commission') with effect from 02.01.2019 (Amendment List - 003).
2. The petitioner in W.P. (C) 4672/2019 prays that directions be
issued to the respondents to grant six months' time for the
implementation of the amendment (Amendment List-003 to IP-2018)
introduced in respect of the drug in question. The petitioners in W.P.
(C) 6523/209 pray that directions be issued to the respondents to grant
twelve months' time for implementation of the amendment in
question. The petitioners contend that no time has been granted by
respondent no.2 to the drug manufacturers to adapt to the amended
standard. The drug in question (Albendazole Tablets) manufactured by
the petitioners do not meet the solubility test, as introduced by the
amendments in question. The petitioners, essentially, seek that they be
permitted to sell the drug in question, which does not meet the
amended standards, for a period of six/twelve months to enable them
to adapt the production process to produce the drug in question that
conforms to the amended standards.
3. At the outset, it will be relevant to refer to the amendment in
question to the Indian Pharmacopoeia on 02.01.2019. The said
amendment (Amendment List 003 to IP-2018) is set out below: -
"Albendazole Tablets
Change from: Albendazole Tablets contain
Albendazole. The tablets may contain permitted
flavouring agents.
To: Albendazole Tablets contain Albendazole. The
tablets may be chewable and may contain permitted
flavouring and sweetening agents.
Under Tests Insert
Dissolution (2.5.2).
Medium 900 ml of 0.1M hydraulic acid.
Speed and time.75 rpm and 30 minutes.
Withdraw a suitable volume of the medium and
filter. Dilute 1.0 ml of filtrate to 50.0 ml with 0.1 M
sodium hydroxide. Measure the absorbance of tlie
resulting solution at the maximum at about 308 nm
(2.4.7). Calculate the content of C12H15N3O2S per
tablet talcing 742 as the specific absorbance at 308
nm.
D. Not less than 80 per cent of the stated amount
of C12H15N3O2S.
Labelling.
Change from: The label states that the tablets should
be chewed before swallowing.
To: The label states, whenever applicable, tire
tablets should be chewed before swallowing"
4. The aforesaid amendment is hereafter referred to as 'the
amendment in question'.
5. The petitioners were granted licences for manufacturing
Albendazole 400 mg Tablets which has been extended from time to
time. The standards for Albendazole Tablet was specified in IP, 1996.
The standard required that the said tablets contain not less than 92.5%
and not more than 107.5% of stated amount of Albendazole
C12H15N3O2S. Thus, all manufacturers were required to conform to the
said standards. It is stated that the said standard continued without any
amendment up to the year 2018 till the amendment in question
(Amendment List-003) was introduced by the IP Commission.
6. It is stated on behalf of the petitioners that they are holding
purchase orders from various purchasers for supply of the drug in
question but are unable to supply the drug in question, for the reason
that they are not in a position to manufacture drug in question
(Albendazole 400mg) which meets the amended standards for the said
drug, as the same is not soluble. It is stated that the petitioners have
secured the purchase orders pursuant to invitation to tenders that were
floated prior to the amendment in question being notified.
7. It is earnestly contended on behalf of the petitioners that the
petitioners would suffer significant losses and would also be exposed
to claims of damages if the implementation of the amendment in
question is not deferred.
8. The import of the amendment in question is that the
manufacturers and dealers are now precluded from selling the drug in
question (Albendazole Tables) which do not meet the solubility test.
The petitioners, in effect, seek directions to enable them to supply the
drugs which do not conform to the standards as notified, in order to
exhaust their stocks and to manufacture the drugs that meet the
amended standards.
9. The Indian Pharmacopoeia is the official book specifying the
drugs in India as specified in Second Schedule of the Drugs and
Cosmetics Act, 1940. Clause 5 of the Second Schedule of the said Act
is relevant and is set out below:-
"5. Other drugs:
(a) Drugs included in Standards of identity, purity
the Indian and strength specified in the
Pharmacopoeia edition of the Indian
Pharmacopoeia for the time
being in force and such other
standards as may be
prescribed.
In case the standards of
identity, purity and strength
for drugs are not specified in
the edition of the Indian
Pharmacopoeia for the time
being in force but are
specified in the edition of the
Indian pharmacopoeia
immediately preceding, the
standards of identity, purity
and strength shall be those
occurring in such
immediately preceding
edition of the Indian
Pharmacopoeia and such
other standards as may be
prescribed.
(b) Drugs not included Standards of identity, purity
in the Indian and strength specified for
Pharmacopoeia but drugs in the edition of such
which are included official Pharmacopoeia of
in the official any other country for the
Pharmacopoeia of time being in force and such
any other country. other standards as may be
prescribed.
In case the standards of
identity, purity and strength
for drugs are not specified in
the edition of such official
Pharmacopoeia for the time
being in force, but are
specified in the edition
immediately preceding, the
standards of identity, purity
and strength shall be those
occurring in such
immediately preceding of
such official Pharmacopoeia
and such other standards as
may be prescribed.]]"
10. The IP Commission is an autonomous institute and is, inter alia,
entrusted with the function to revise and publish the Indian
Pharmacopoeia on a regular basis. The IP Commission undertakes the
said function to ensure inclusion of drug monographs and their further
upgradation from time to time. The IP Commission published the 8th
edition of IP, 2018 which came into effect from 01.01.2019.
11. It is stated that Albendazole Tablets have been recommended by
World Health Organization (WHO) as they are effective, inexpensive
and easy to administer for the treatment of helminth infections. The
said drug is used widely in the National Health Programme for
controlling parasitic infection in India.
12. Albendazole Tablets are sometimes swallowed whole either
intentionally or unintentionally and therefore, it was felt necessary that
such tablets comply with the test for dissolution. Admittedly, the
International Pharmacopoeia published by WHO requires that the
tablets comply with the test for disintegration or dissolution. It is
affirmed on behalf of the IP Commission that the issue of the
Albendazole Tablets in meeting the aforesaid standard has been the
subject matter of discussions at various platforms. It is contended on
behalf of IP Commission that WHO studies have shown that the
dissolution properties of Albendazole Tablets in the market were poor
and therefore, the monograph included in the International
Pharmacopoeia for Albendazole Tablets was revised in the year 2015
to provide for the test of dissolution.
13. The learned counsel appearing for IP Commission submitted
that the property of Albendazole Chewable tablets to dissolve was
considered to be necessary for the said drug to be effective. He also
referred to the chronology of events that had preceded the publication
of the amendment in question as part of Indian Pharmacopoeia.
14. It is stated that as early as on 22.08.2016, a draft was prepared
according to the International Pharmacopoeia and on 26.10.2016, the
IP Commission had sent various e-mails to various drug
manufacturers for providing the method and data of dissolution testing
of Albendazole Tablets. It is stated that some of the drug
manufacturers had also forwarded the data for the same.
15. On 23.03.2017, the dissolution test drafted for Albendazole
Tablets was sent to experts and various manufacturers for their
opinion/comments. Thereafter, on 06.09.2017, a Committee was
formed by the Secretary cum Scientific Director of the IP Commission
for incorporation of the dissolution test in the monograph of
Albendazole Tablets. It is affirmed that on 11.09.2017, IP
Commission sent e-mails to various manufacturers for their opinion on
inclusion of the dissolution test in Albendazole Tablets.
16. It is affirmed on behalf of IP Commission that on 27.09.2017,
the meeting of an Expert Committee was held and all members had
unanimously agreed that dissolution test should be included as a
necessary standard for Albendazole Tablets. The dissolution test was
drafted and uploaded on the website of the IP Commission for public
comments on 12.10.2017.
17. The learned counsel appearing for the IP Commission has also
drawn the attention to a communication received from Dr Madhur
Gupta of WHO, which, inter alia, states that "dissolution test being of
critical importance as part of the assay in Albendozole; the revision of
monograph in Indian Pharmacopoeia needs to be incorporated at the
earliest ..".
18. It is affirmed that that on 25.05.2018, the 37th Scientific Body
meeting was held and at the said meeting, discussions were held on
the draft dissolution test for Albendazole Tablets. It is also affirmed
that till that date, no suggestion had been received from other
stakeholders. Thereafter the matter was also discussed at the Expert
Working Group Meeting held from 29.08.2018 to 31.08.2018 and the
experts were of the opinion that the standards be harmonized with the
International Pharmacopoeia.
19. Thereafter, on 14.09.2018, the draft dissolution test as per
International Pharmacopoeia was sent to certain experts and
manufacturers for comments and it was also uploaded on the website
of the IP Commission for public comments. The draft was again
discussed by the expert working group at the meetings held on
29.10.2018 and 31.10.2018 and a dissolution test was approved in the
amendment list. Thereafter, on 22.12.2018 incorporation of the
dissolution test in Amendment List-003 (amendment in question) was
approved at the 39th Scientific Body meeting of the IP Commission
and the same was thereafter published on 02.01.2019.
20. It is clear from the above that the necessity of the drug in
question being soluble cannot be disputed. There is also no material to
doubt that the incorporation of the solubility test as a necessary
standard was of critical importance, as also communicated by WHO
21. Undisputedly, the proposal for including the dissolution test as a
part of the monograph of Albendazole Tablets was in public domain
for a considerable period. The draft of the dissolution test had been
uploaded on the IP Commission's website on 12.10.2017 and
thereafter on 14.09.2018. Admittedly, the said standard is also a part
of the International Pharmacopoeia since 2015.
22. In view of the above, there can be no dispute that all
manufacturers had sufficient notice to ensure that their products meet
the international standards. The failure of certain drug manufacturers
to upgrade the standards of the drugs manufactured by them cannot be
accepted as a ground for deferring the implementation of such
standards.
23. It is also stated on behalf of the IP Commission that there are
large number of manufacturers who are producing the drug in question
meeting the amended standard.
24. It was contended on behalf of the petitioners that the IP
Commission had not sent any email to the petitioners but to other
manufacturers. This is of little relevance and the draft test had been
placed on the website of the IP Commission on two occasions. More
importantly, the solubility test was already incorporated as the
monograph of the drug in question in the International Pharmacopoeia
way back in the year 2015.
25. It is necessary to bear in mind that the import of accepting the
petitioners' contention would be that a sub-standard drug would be
used by the consumers. The drug in question is also used for the health
programme for deworming and is administered to a large number of
persons on the Deworming Day, which is fixed twice a year. Clearly,
it would not be in public interest if a drug which is relatively
ineffective is permitted to be used.
26. Ms Amita Gupta, learned counsel appearing for the petitioners
had contended that in several other cases, the IP Commission had
granted relaxation for implementing the changes introduced in the
Indian Pharmacopoeia. In particular, she referred to a letter dated
10.12.2014, which was issued by the IP Commission relaxing the
implementation of the changes prescribed in IP Addendum, 2015 for a
period of three months. She had also relied on a similar letter dated
27.03.2018 in respect of the standards prescribed in IP-2018. She
submitted that a similar relaxation ought to be granted in respect of the
amendment in question (Amendment List-003 to IP-2018).
27. The said contention is unpersuasive. It has been affirmed on
behalf of the IP Commission that after publication of IP-2014 and IP
Addendum, 2015, the IP Commission had received various
representations by stakeholders to relax the time for implementing the
same to comply with the new drug monograph that had been added by
the IP Commission. Similarly, after publication of IP-2018, similar
requests were made for extending the time to implement to the new
standards. He submitted that such relaxations were not granted in
respect of upgradation that were already included in the IP standards.
28. In view of the above, the case of the petitioners cannot be
considered similar to the instances where the IP Commission had
granted such relaxation. In view of the above, the contention that the
period for implementing the amendment in question was also required
to be deferred, cannot be accepted. Since it is also relevant to note that
it is not disputed that the dissolution test has been a part of the
International Pharmacopoeia since 2015 and there is no justifiable
reason for the petitioners not to have taken preparatory steps for
manufacturing drugs of the requisite standards.
29. In view of the above, this Court does not find any infirmity in
the action of the IP Commission in issuing the Amendment in question
(Amendment List-003 to IP-2018) with effect from 02.01.2019.
30. The petitions are unmerited and are, accordingly, dismissed.
The pending applications are disposed of.
VIBHU BAKHRU, J
JULY 04, 2019
pkv
