Jharkhand High Court
M/S Glaxosmithkline Asia Pvt. Ltd vs The State Of Jharkhand on 11 January, 2024
Author: Sanjay Kumar Dwivedi
Bench: Sanjay Kumar Dwivedi
IN THE HIGH COURT OF JHARKHAND AT RANCHI
Cr.M.P. No. 2175 of 2020
M/s GlaxoSmithKline Asia Pvt. Ltd.
through its Authorized Representative
Kanika Shah Wadhwa ..... ... Petitioner
with
Cr.M.P. No. 2185 of 2020
M/s Hindustan Unilever Limited,
through its Authorized Representative
Nidhi Sudan ..... ... Petitioner
Versus
1. The State of Jharkhand.
2. The Drug Inspector,
having its office at Deoghar, Deoghar. ..... ... Opposite Parties
[in both cases]
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CORAM : HON'BLE MR. JUSTICE SANJAY KUMAR DWIVEDI
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For the Petitioners : Mr. Indrajit Sinha, Advocate.
: Mr. Rishav Kumar, Advocate.
For the State : Mr. Mohammand Asghar, A.C. to Sr. S.C.-II.
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07/ 11.01.2024 In both these cases common complaint case is under
challenge, as such, both these petitions are being heard together with
the consent of the parties.
2. Heard Mr. Indrajit Sinha, learned counsel appearing for the
petitioners and Mr. Mohammad Asghar, learned counsel for the State.
3. Both these petitions have been filed for quashing of the
entire criminal proceedings including the summoning order dated
12.06.2018, in connection with D & C No. 02 of 2018, pending in the
court of learned District & Additional Sessions Judge-II, Deoghar.
4. The complaint case was lodged by the O.P. No. 2 against
the Petitioners, which relates to sale, stocking and distribution of
Paracetamol Fast Release Tablets (trade name Crocin Advance), bearing
batch no. R14439 manufactured in December 2014 with expiry date as
November 2016. It is alleged that subject medicines are not of standard
quality as they have failed in the disintegration test as provided in the
Indian Pharmacopeia. It has been further alleged that the Petitioner has
not complied with the Opposite Party's notice requiring submission of
the purchase and distribution details of Crocin Advance (Batch no.
R14439) duly signed and stamped by the competent authority. In
addition, it has been alleged that the Petitioner has not furnished to the
Opposite Party the license for marketing Crocin Advance. Hence,
the Petitioner is in Contravention of Sections 18(a) (i) and 18(a) (vi)
punishable under Section 27(b) of the Drugs Act and they are also in
contravention of Sections 18B and 22(1) (cca) punishable under
Sections 28 A and 22 (3) of the Drugs Act.
5. Mr. Indrajit Sinha, learned counsel appearing for the
petitioners submits that M/s Glaxo Smith Kline Asia Pvt. Ltd. entered
into an agreement with manufacturer Remidex on 01.03.2012. He
submits that M/s Glaxo Smith Klin Consumer Healthcare Limited (now
Hindustan Unilever Limited) supplied Crocin Advance Tablets to M/s
Kusum Enterprises. He further submits that on 14.08.2015, the Drug
Inspector, Deoghar, inspected M/s Kusum Enterprises at Deoghar and
medicine Crocin Advance Tablets manufactured by Remidex Pharma
Pvt. Ltd. was taken as sample for analysis. He further submits that the
State Drug Testing Laboratory, Ranchi, received the sample from the
Drug Inspector, Deoghar on 05.11.2015. He Submits that the
Government Analyst, State Drug Testing Laboratory, Ranchi vide its
report dated 12.01.2016 declared the said medicine not of standard
quality, as defined in the Drugs and Cosmetics Act, 1940. He further
submits that on 08.06.2016, the Drug Inspector, Deoghar sent a copy of
the analyst report and one portion of sealed sample of medicine to M/s
Glaxo Smith Kline Consumer Healthcare Limited and the analyst report
was also sent to M/s Remidex Pharma Pvt. Ltd. He also submits that on
04.07.2016, M/s Glaxo Smith Kline Asia Pvt. Ltd. informed the Drug
Inspector, Degohar that it is only marketing company of Crocine
Advance and the product is manufactured by Remidex Pharma Private
Limited on principal-to-principal basis. He submits that the Drug
Inspector's letter was replied by the Remidex Pharma Pvt. Ltd. on
09.07.2016 and the criminal case was filed on 21.04.2018 by the Drug
Inspector, Deoghar. He further submits that the said drug was already
expired in the November, 2016 and the complaint case was filed on
21.04.2018 and in view of that the valuable right under Sub-Section 4
of Section 25 of the Drugs and Cosmetics Act, 1940 has been taken
back, as the petitioner has not been able to avail the valuable right for
sending the sample for re-testing by the Central Laboratory. He submits
that in view of the above, the case of the petitioners are fully covered in
view of the judgment of the Hon'ble Supreme Court in the case
of Laborate Pharmaceuticals India Limited & Ors. Versus State of
Tamilnadu, reported in (2018) 15 SCC 93, wherein the Hon'ble
Supreme Court in paras-6, 7 and 8 held as follows:-
6. A reading of the provisions of Sections 23(4)
and 25 of the Act would indicate that in the
present case the sample having been taken
from the premises of the retailer had to be
divided into four portions; one portion is
required to be given to the retailer; one
portion is required to be sent to the
Government Analyst and one to the court and
the last one to the manufacturer whose name,
particulars, etc. is disclosed under Section 18-A
of the Act. In the present case, admittedly, one
part of the sample that was required to be sent
to the appellant (manufacturer) under Section
23(4)(iii) of the Act was not sent. Instead,
what was sent on 22-3-2012 was only the
report of the Government Analyst. When the
part of the sample was not sent to the
manufacturer, the manufacturer could not
have got the same analysed even if he wanted
to do so and, therefore, it was not in a position
to contest the findings of the Government
Analyst. In the present case, the sample was
sent to the appellant manufacturer on 10-8-
2012 and on 13-9-2012 the appellant had
indicated its desire to have another part of the
sample sent to the Central Laboratory for
reanalysis. This was refused on the ground
that the aforesaid request was made much
after the stipulated period of 28 days provided
for in Section 25(3) of the Act.
7. The cognizance of the offence(s) alleged in
the present case was taken on 4-3-2015
though it appears that the complaint itself was
filed on 28-11-2012. According to the
appellant the cough syrup had lost shelf life in
the month of November 2012 itself. Even
otherwise, it is reasonably certain that on the
date when cognizance was taken, the shelf life
of the drug in question had expired. The
Magistrate, therefore, could not have sent the
sample for reanalysis by the Central
Laboratory.
8. All the aforesaid facts would go to show that
the valuable right of the appellant to have the
sample analysed in the Central Laboratory has
been denied by a series of defaults committed
by the prosecution; firstly, in not sending to the
appellant manufacturer part of the sample as
required under Section 23(4)(iii) of the Act;
and secondly, on the part of the Court in taking
cognizance of the complaint on 4-3-2015
though the same was filed on 28-11-2012. The
delay on both counts is not attributable to the
appellants and, therefore, the consequences
thereof cannot work adversely to the interest
of the appellants. As the valuable right of the
accused for reanalysis vested under the Act
appears to have been violated and having
regard to the possible shelf life of the drug we
are of the view that as on date the prosecution,
if allowed to continue, would be a lame
prosecution.
6. He submits that this aspect of the matter has further been
appreciated by the Hon'ble Supreme Court in the case of Medicamen
Biotech Limited and Another v. Rubina Bose, Drug Inspector,
reported in (2008) 7 SCC 19. He further submits that all these
judgments have been further considered by the Hon'ble Supreme Court
in the case of Medipol Pharmaceutical (India) (P) Ltd. Versus Post
Graduate Institute of Medical Education & Research, reported in
(2021) 11 SCC 339. He further submits that based upon the above
judgments, this court has further passed the order by way of quashing
the entire criminal proceeding in the case of Jackson Laboratories
Private Limited & Ors. Versus State of Jharkhand & Anr., reported in
2022 SCC OnLine Jhar 1134 as well as in the case of M/s Alkem
Laboratories Limited Versus The State of Jharkhand & Anr. passed in
W.P.(Cr.) No. 312 of 2017. On these grounds, he submits that the entire
criminal proceeding may kindly be quashed.
7. Learned counsel appearing for the State submits that the
drug was found not to be of standard, in view of that the complaint case
has rightly been filed. He submits that in view of that the case is made
out, as such, this court may not interfere in the matter at this stage.
8. It is an admitted position that the drug was manufactured in
the month of December, 2014 and the expiry of the said drug was in the
month of November, 2016 and the complaint case was filed on
21.04.2018, in view of that the self-life of the said drug was already
expired. Since the complaint was not filed within time, the petitioners'
valuable right has been taken in light of Sub-Section 4 of Section 25 of
the Drugs and Cosmetics Act, 1940 in view of the judgment of the
Hon'ble Supreme Court in the case of Laborate Pharmaceuticals India
Limited & Ors. (Supra) and also in the case of Medipol
Pharmaceutical (India) (P) Ltd. (Supra).
9. Thus, it is crystal clear that on the date when the cognizance
was taken the self-life of the said drug was expired and in view of that
the valuable right of the petitioners for sending the sample for re-testing
to the Central Laboratory has been denied by the default committed by
the prosecution and once a valuable right is denied, the case of the
petitioner is covered in light of the above judgments, as has been noted
in the argument of learned counsel appearing for the petitioners.
10. In view of the above, the entire criminal proceedings
including the summoning order dated 12.06.2018, in connection with D
& C No. 02 of 2018, pending in the court of learned District &
Additional Sessions Judge-II, Deoghar, are hereby, quashed.
11. Both these petitions are allowed and disposed of.
(Sanjay Kumar Dwivedi, J.)
Amitesh/-
