Madras High Court
Johnson & Johnson Private Limited vs The State Of Tamil Nadu on 26 July, 2023
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IN THE HIGH COURT OF JUDICATURE AT MADRAS
DATED : 26.07.2023
CORAM
THE HONOURABLE MR. JUSTICE N. ANAND VENKATESH
Crl.O.P No.30273 of 2022
and Crl.M.P Nos.18541 and 18542 of 2022
1.Johnson & Johnson Private Limited
Rep.by its Authorized representative
Mr.Ramesh Bhukan,M/45
Lal Bahadur Shastri Marg, Mulund (West)
Mumbai City MH 400080 IN.
2.Vikas Chandra Srivastava, A-53
Managing Director,
Johnson & Johnson Private Limited
(Consumer Products Division)
Lal Bahadur Shastri Marg, Mulund (West)
Mumbai City MH 400080 IN.
3.Ramesh Bhuban, A/45
Head of Commercial Quality (Pharma)
Johnson & Johnson Private Limited
Lal Bahadur Shastri Marg, Mulund (West)
Mumbai City MH 400080 IN. .. Petitioners/A4 to A6
.Vs.
The State of Tamil Nadu
Rep.by the Drugs Inspector
T.Nagar Range
O/o.the Assistant Director of Drugs Control
Teynampet, Zone III
Chennai 600 006.
https://www.mhc.tn.gov.in/judis
... Respondent
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PRAYER: Criminal Original Petition filed under Section 482 of the Code of
Criminal Procedure, to quash the criminal complaint in CC.1047/2022 filed
against the petitioners and three others, pending on the file of the learned IV
Metropolitan Magistrate, Saidapet, Chennai..
For Petitioners : Mr.R.Parthasarathy
Senior Counsel
for Mr.R.Palaniandavan
For Respondent : Mr.A.Gopinath
Government Advocate (Crl.Side)
ORDER
This Criminal Original Petition has been filed seeking to quash the
proceedings in C.C.No.1047 of 2022, pending on the file of the learned IV
Metropolitan Magistrate, Saidapet, Chennai.
2.The petitioners have been arrayed as A4, A5 and A6 and they are facing
the criminal complaint filed by the respondent for the alleged offence u/s 18(c)
of the Drugs and Cosmetics Act, 1940 (hereinafter referred as “the Act”) r/w
Section 65(5)(1)(b) of the Drugs and Cosmetics Rules, 1945 (hereinafter
referred as “the Rules”).
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3.Heard Mr.R.Parthasarathy, learned Senior Counsel for the petitioners
and Mr.A.Gopinath, learned Government Advocate (Crl.Side) appearing on
behalf of the respondent.
4.The main ground on which the respondent has lodged the prosecution
against the petitioners is captured in the counter filed by the respondent and the
same is extracted hereunder:
8.It is submitted that the 1st petitioner raised the following
purchase invoices (Table 2) to M/s.Medybiz Pharma Pvt.Ltd. New No.9,
Old No.4, 2nd Floor, Rajamannar Street, T.Nagar, Chennai 600 017
mentioning the Drug License number 4765/20B, 4648/21B (invalid)
Table 2
Sl. No. Name of the B.No.481276 Purchased from Invoice No.&
1 Drug Imbruvica caps Jhonson & date
140 mg 90's pack Jhonson Pvt.Ltd, 4122002060
Madhavaram 24.11.17
2 Remicade 100 mg Inj HBM94014A Jhonson & 4122002873
Jhonson Pvt.Ltd, 25.01.18
Madhavaram
3 Remicade 100 mg Inj HCM05015 Jhonson & 4122002874
Jhonson Pvt.Ltd, 25.01.18
Madhavaram
4 Imbruvica caps 140mg 90's 481402 Jhonson & 4122002874
pack Jhonson Pvt.Ltd, 25.01.18
Madhavaram
The respondent filing the purchase invoices given by the 1" respondent in
the type set and it may be treated as part and parcel of this counter. The
respondent submits that in our show cause memo Ref
no,1024/DI/TNR/2018 Dated 30.3.21 the company to whom drugs were
supplied
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specifically mentioned. Hence it is not correct to say in paras 7&8 of the
petition that the petitioners were falsely and improperly arrayed as accused.
5.It is clear from the above that the petitioners are prosecuted for the
reason that they have raised the invoices for a particular address and whereas
the drugs were supplied to a different place. Hence, it is contended that the
supply of the drugs to a different address other than the one for which the
license was given becomes an offence u/s 18(c ) of the Act and Rule 65
(5)(1)(b) of the Rules.
6.The short issue that arises for consideration is as to whether the
petitioners have supplied the drugs to the address which does not have a license
and whether the purchase invoice which was not raised to the licensed premises
will tantamount to violation of the Act and Rules warranting the prosecution of
the petitioners.
7.It is seen from records that a show cause notice has been issued by the
respondent dated 30.03.2021. In the show cause notice, the very same ground
was put against the petitioners. The petitioners gave a reply for the show cause
notice dated 20.04.2021. In the reply, the petitioners had taken the following
stand:
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4.Medybiz used to operate a warehouse for storage of drugs at the
following location New No.9. Old No 4, 2nd Floor Rajamannar Street, T
Nagar Chennai-17 which was covered by whole sale license in Form 20-B
bearing no. 4765/M III/20B issued by the Asst. Director of Drugs Control,
State of TN. (First Licensed Premise"). The whole sale license of First
Licensed Premise of Medybiz was renewed in 2015 and was valid until
15.07.2020
5.Sometime in 2017. Medybiz changed its warehouse address to the
following location 8/28, Maduraiveeram kovil street. T Nagar, Chennai 17
for which it also received whole sale license in Form 20-B bearing no 5823/
M 11/208 issued by the Asst. Director of Drugs Control State of TN. ("Second
Licensed Premise")
6.It is important to note here that when Medybiz shifted from
First Licensed Premise to Second Licensed Premise, J&J started
delivering above mentioned medicines to Medybiz at Second Licensed
Premise only. It did not deliver medicines to First Licensed Premises at all
after Medybiz had shifted from that premise.
7.Medybiz, in its letter dated May 10, 2020 addressed to the
Additional Director of Drugs, State of T.N. herewith annexed as Annexure-1,
has confirmed that all the above medicines were received at the Second
Licensed Premise. In fact, Medybiz has clarified that the said medicines
could not have been delivered by J&J at the First Licensed Premise as there
is a third-party boutique being operated out of that premises
8.Moreover, from the Show Cause Nolice, it appears Shri Thiru
Rajesh Kumar, the then Drugs Inspector, found records pertaining to Second
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Licensed Premises which indicate that the above medicines were stocked
and sold by Medybiz at the Second Licensed Premises. This clearly
establishes that the J&J supplied medicines to Medybiz and at Second
Licensed Premises only.
9.Since the whole sale license of First Licensed Premise was valid
until 15.07.2020, J&J had inadvertently mentioned the First Licensed
Premise details on the invoice for sale the abovementioned drugs to
Medybiz However, as mentioned earlier, since Medybiz was operating out of
Second Licensed Premises, J&J delivered the afore mentioned drugs to
Medybiz and at the Second Licensed Premises only The inadvertent human
error was rectified by J&J on discovery and subsequentlyall drugs were sold
to Medybiz and delivered to Second Licensed Premise only.
10.The inadvertent human error was rectified by J&J on discovery
and subsequently all drugs were sold to Medybiz and delivered to Second
Licensed Premise only.
8.It is clear from the above that the petitioners have given a clear reply
and they have specifically stated that the drugs were in fact delivered only to the
licensed premises and the invoice that was raised containing the old address was
an inadvertent mistake.
9.The above stand taken by the petitioners in the reply notice was not
even considered by the respondent before filing the complaint. This Court dealt
with an issue under the Factories Act and Rules, wherein a reply was given to
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the show cause notice and the same was not considered at the time of filing the
complaint and it was held as follows:
18.The petitioners have given a detailed reply for the Show
Cause Notice issued by the respondent. This reply has not been
taken into consideration either at the time of granting sanction or at
the time of filing of the complaint. This Court has already held that
where a reply has been given to the Show Cause Notice, the said
reply has to be considered and dealt with at the time of filing of the
complaint, failing which, the complaint itself becomes unsustainable
on the ground of non application of mind. Useful reference can be
made to the judgment of this Court in K.Masthan Rao .Vs. State,
rep. by Inspector of Factories, First Circle, Vellore reported in
2014 (3) MWN (Cr.) 86. The relevant portions of the judgment is
extracted hereunder:
“27. As pointed out earlier, the form 3A intimating notice
of change of Deputy Chief Engineer, minutes of the Canteen
Advisory Committee meeting, minutes of Safety Committee
meeting, the report of examination of cranes, ropes, etc.,
building stability certificate were all forwarded to the
respondent/complainant as well as the head of department.
Thereafter, on 28.09.2012, another representation was made
enclosing copy of the building stability certificate issued by the
competent person and simultaneously requesting the Chief
Inspector of Factories to nominate recognised persons for
signing them stability certificate. Despite all these factual
submissions, the complaints have been filed by the respondent
verbatim repeating the allegations made in the show cause
notice. Surprisingly, there is no reference to the explanations
submitted by the petitioners and as to how the petitioners have
not complied with the deficiencies pointed out, as to how the
same stand rectified and such other matters. In the show cause
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notice dated 09.04.2012, it has been stated that on 22.03.2012,
an inspection was conducted in the factory and the deficiencies,
which were noticed in the course of inspection, were listed out
as serial nos. 1 to 16 and the petitioners were called upon to
explain as to why, prosecution should not be initiated against
them by giving them seven days time to submit their
explanation in writing, failure to avail the opportunity would be
considered that there is no explanation to offer and without
further notice, action would be taken. Therefore, the
respondent/complainant being a statutory authority having
provided for an opportunity to the petitioner to show cause
ought to have considered the correctness of the proprietary of
the explanations offered.
28. In terms of Rule 102 of the Tamil Nadu Factory
Rules, 1950, the Occupier, Owner or Manager of a factory
shall furnish information to an inspector for the purpose of
satisfying himself whether any of the provisions of the Act have
been complied with or whether any order of the Inspector has
been carried out and any demand of such information, if made
during the course of an inspection, shall be complied with
forthwith or if made in writing, shall be complied with within
seven days of receipt thereof. Thus, the rule contemplates an
opportunity for compliance. If the respondent/complainant has
pointed out certain contraventions and if the contraventions
exist, the contravener is bound to comply with within seven
days. The case on hand is slightly different in the sense that the
petitioners have submitted their explanations showing cause in
respect of the allegations made in the show cause notice. In
such circumstances, the respondent/complainant cannot ignore
the reply to the show cause notice and proceed to lodge the
complaint, as if he has not received any reply.
29. As noticed above, there is no reference to the reply
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submitted by the petitioner. The complaint
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was signed by the respondent on 20.06.2012 and filed before
the Court on 21.06.2012, presumably not in full form and
appears to have been returned and re-presented on 30.09.2013.
In the interregnum, the petitioner has been given the replies
dated 16.04.2012 and 31.05.2012. That apart, the further
explanations dated 12.07.2012 and 28.09.2012, were submitted
much prior to the date on which, the complaint was re-
presented i.e., on 30.09.2013. There is no explanation forth
coming as to why the complaint which was presented on
21.07.2012 was returned and as to why the complaint was re-
presented after more than one year. Therefore, this Court has
no hesitation to hold that the complaint is vitiated on account of
total non-application of mind”.
10.It is clear from the above that where a reply given to the show cause
notice is not considered at the time of filing of the complaint, the complaint
itself will become unsustainable. That is exactly what has happened in the
present case also. After the reply was given by the petitioners, the respondent
did not even verify as to whether the drugs were supplied to the licensed
premises and straightway assumed that it was supplied only to a non-licensed
premises based on the invoice that was raised. Thereafter, the complaint was
filed before the Court below. On this ground alone, the complaint filed against
the petitioners is liable to be interfered by this Court.
11.This Court also had an occasion to dealt with an issue where such
supply was made to a person holding a license and whereas the person was
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carrying on with the business in a different premises. In Crl.OP.No.30405 of
2022, dated 10.07.2023, this Court has held as follows:
12. A reading of the relevant Rules and the Forms
shows that the manufacture for sale or distribution of drugs
can be made by those persons, who possess a licence
subject to the conditions applicable to the licence. In so far
as condition No.3(ii) under Form 20B is concerned, no sale
of any drug shall be made to a person not holding the
requisite licence to sell, stock or exhibit for sale or distribute
the drug.
13. The specific allegation that has been made against
the petitioners is that they had sold the drug to M/s.Oxiad
(India) Gases (P) Limited, which did not possess a licence to
run the unit at Royapettah and in fact, they had a licence to
run the unit only at Tiruchirapalli.
14. Rule 65(5) of the Rules prescribes the procedure
to be adopted for supply of a drug. What has to be ensured
at the time of supply of the drug is that the person or the
entity, to whom it is supplied, must possess a licence.
15. M/s.Linde India Limited and M/s.TN Oxygen (P)
Limited satisfied themselves with regard to the fact that
M/s.Oxiad (India) Gases (P) Limited had a valid licence. It is
not possible for these two entities to follow up with
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M/s.Oxiad (India) Gases (P) Limited and see as to where all
the drugs are being supplied/sold by them. That is not
definitely within the control of these two entities.
16. If M/s.Oxiad (India) Gases (P) Limited had sold
the drugs in areas, for which, they do not possess licence,
that cannot be put against M/s.Linde India Limited and
M/s.TN Oxygen (P) Limited and they cannot be prosecuted
by initiating penal action.
12.This Could held that at the time of supply of the drugs, it must only be
seen if a person to whom it is supplied holds a valid license. If the person to
whom it is supplied later on supplies or sells them in areas where they do not
possess license, that cannot be put against the manufacturer who does not have
control over the subsequent supplier.
13.In the instant case, the petitioners have supplied the drugs only to a
licensed premises and have confirmed the same even in the reply notice. In
view of the same, the continuation of the prosecution against the petitioners are
the alleged contravention of the Act and Rules, will amount to abuse of process
of Court, which requires interference of this Court in exercise of its jurisdiction
u/s 482 of Cr.PC.
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14.In the light of the above discussion, the proceedings in
C.C.No.1047/2022, on the file of the IV Metropolitan Magistrate, Saidapet,
Chennai, is hereby quashed only insofar as the petitioners are concerned. The
Court below shall proceed further to deal with the complaint against the other
accused persons in accordance with law and complete the proceedings within a
period of three months from the date of receipt of copy of this order.
15.This criminal original petition is allowed in the above terms.
Consequently, connected miscellaneous petitions are closed.
26.07.2023
Index : Yes/No
Internet : Yes/No
Speaking Order/Non-Speaking Order
KP
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To
1.IV Metropolitan Magistrate
Saidapet, Chennai.
2.The Drugs Inspector
The State of Tamil Nadu
T.Nagar Range
O/o.the Assistant Director of Drugs Control
Teynampet, Zone III
Chennai 600 006.
3.The Public Prosecutor,
High Court of Madras,
Madras.
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N. ANAND VENKATESH,. J.
kp
Crl.O.P No.30273 of 2022
and
Crl.M.P Nos.18541 and 18542 of 2022
26.07.2023
https://www.mhc.tn.gov.in/judis
