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Section 25(3) in the Drugs and Cosmetics Act, 1940
Section 24 in the Drugs and Cosmetics Act, 1940
Section 482 in The Code Of Criminal Procedure, 1973
the Drugs and Cosmetics Act, 1940
Section 25 in the Drugs and Cosmetics Act, 1940

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Madras High Court

Poddar Pharmaceuticals [Link] vs State Represented By on 20 September, 2018

BEFORE THE MADURAI BENCH OF MADRAS HIGH COURT

Dated: 20.09.2018

Reserved on
12.09.2018
Delivered on
20.09.2018

CORAM

THE HONOURABLE MR. JUSTICE N. ANAND VENKATESH

[Link] (MD).No.16361 of 2018

and
[Link](MD).Nos.7256 & 7257 of 2018

[Link] Pharmaceuticals [Link].,

E-35, Indl. Area, Haridwar,
Uttarakhand ? 249401
rep. by its Managing Director
[Link] Kumar Jain, S/o. Prakash Chand Jain.

[Link] Kumar Jain, S/o. Prakash Chand Jain (45/m)

Managing Director,
Poddar Pharmaceuticals [Link].,
E-35, Indl. Area, Haridwar,
Uttarakhand ? 249401
... Petitioners

.Vs.
State represented by
Drugs Inspector Aranthangi Range
O/o, the Asst. Director of Drugs Control,
Thanjavur Zone, Thanjavur-1.
... Respondent
Prayer:
Criminal Original Petition filed under Section 482 of Cr.P.C, 1973, to
call for records in S.T.C. No. 214 of 2018 pending in the Hon'ble Court of
Judicial Magistrate at Aranthangi and QUASH the same.

For Petitioners : [Link] Karthikeyan

For Respondents : [Link] sekaran

 [Link] Prosecutor

:ORDER

This petition has been filed seeking to quash the Criminal Proceedings initiated by the respondent in
[Link]. 214 of 2018, on the file of the Judicial Magistrate, Aranthangi, for the Contravention of
Section 18(a) (i) & 18B of the Drugs and Cosmetics Act 1940, Punishable under Section 27(d) & 28A
of the said Act (hereinafter called ?the Act?).

2. The case of the prosecution is that on 20.09.2016, the Drugs Inspector took a sample of Diethyl
Carbamazine Citrate IP Tablets, [Link]: TY- 125, M/D: 04/2016, E/D: 03/2018 Mfg. By M/s. Podder
Pharmaceuticals Pvt. Ltd., for analysis from the Government Hospital, Arandhangi, Pudukkottai
District, and the sample was sent for analysis to the Government Analyst (Drugs), Drugs Testing
Laboratory, Chennai-06. The sample was tested and the Government Analyst by his report dated
21.12.2107, observed that the Drug is ?Not of Standard Quality? as defined in Act and Rules and does
not conform to the General Description for Tablet and to IP specification for Diethyl carbamazine
Citrate Tablets with respect to the content of Diethyl carbamazine Citrate.

3. The respondent issued show cause memo to the Pharmacist of the Government Hospital,
Arandhangi, and also the stockist, namely Drug Warehouse, Tamilnadu Medical Services Corporation
Ltd, pointing out the findings of the Government Analyst and got the information that the manufacturer
of the Drug is M/[Link] Pharmaceuticals Pvt. Ltd. By a show cause memo dated 06.01.2018, the
petitioners were informed about the report given by the Government Analyst and a copy of the Analyst
report along with a portion of the sample drawn was also sent to the petitioners, and petitioners were
called upon to give their explanation to the show cause memo.

4. The petitioners by their letter dated 14.02.2018 (posted on 01.03.2018) and which was received on
07.03.2018 by the respondent, gave their reply stating that they do not accept the report of the
Government Analyst. The respondent not being satisfied with the reply, proceeded to file a Criminal
complaint against the petitioners for the contravention of the provisions of the Act. This complaint was
taken on file by the court below and summons were issued to the petitioners. The petitioners have filed
this petition to quash the said complaint.

5. The learned counsel for the petitioners made the following submissions:

a) The sample was tested and report was furnished beyond 60 days in violation of Rule 45 of the Drugs
and Cosmetics Rules and the sample was not kept in proper storage.

b) Only a copy of the report Form-13 was given and whereas the Act stipulates the furnishing of the
original report and the show cause memo was sent to the petitioners, even before the respondent came
to know that the petitioners are the manufacturers and therefore the respondent has pre- decided the
issue.

c) The shelf life of the Drug expired in March 2018 and the Criminal complaint itself has been filed
only after the expiry date of the Drug and therefore the petitioners have lost a valuable right to get the
sample tested by the Central Drug Laboratory and therefore, a vital defence has been taken away,
which is in violation of Section 24(3) of the Act.

d) The Government Hospital, Arandhangi and the Drug Warehouse, Tamilnadu Medical Services
Corporation Ltd., Pudukkottai, did not maintain the Drug as per the stipulation which is clearly shown
in the cover of the Tablet itself and that is the reason for the deficiency found by the Analyst and it is
not due to the manufacturer's fault.

e) The learned Counsel relied upon the following Judgments to support his contentions:

(i) Tata Chemicals Limited Vs Commissioner of Customs (Preventive), Jamnagar reported in (2015) 11
Supreme Court Cases 628.
(ii) Northern Minerals Limited and Others Vs Rajasthan Government and Another reported in (2016)
12 Supreme Court Cases 298.

(iii) Embiotic Laboratories (P) Ltd., rep. by its Director, Vs Drugs Inspector, Erode I Range reported in
2013 (2) MWN (Cr.) 567 in High Court of Madras.

(iv) Alfred Bergs & Co (I) Pvt. Ltd., rep. by its Director & Kamelsh Jain Vs State represented by
Drugs Inspector, Thirunelveli II range in Crl.O.P(MD) No.18084 of 2013 and M.P.(MD) No.1 of 2013.

(v) M/s. Cadila Pharmaceuticals Limited, rep. by its Managing Director, Rajiv Modi Vs A. Sashi, Drug
Inspector, Arumbakkam Range I, in Crl.O.P. No.4461 of 2013.

6. This Court has considered the submissions made by the learned counsel for the petitioners carefully.

7. It is an admitted case that Tablet in question was manufactured by the petitioners. The shelf life of
the Tablet expires in March 2018. This Tablet was supplied to the Warehouse by the Petitioners namely
Drug Warehouse, Tamilnadu Medical Services Corporation Ltd., and in turn this Tablet was sent by the
Stockist to the pharmacy at the Government Hospital, Arandhangi. The sample was taken on
20.09.2016 and one portion of it was immediately sent to the Drugs Testing Laboratory which received
the same on 26.09.2016. The test was conducted in the Laboratory and a report dated 21.12.2017 was
given to the effect that the Tablet is ?Not of Standard Quality? as defined in the Act and Rules and the
sample does not conform to General Description for Tablets and to IP specification for Diethyl
Carbamazine Citrate Tablets with respect to the content of Diethyl Carbamazine Citrate. It is therefore
clear that the sample reached the Drugs Testing Laboratory within 6 days from the date on which the
sample was taken by the Drugs Inspector.

8. The report does not state as to when, the Drug was tested. The statutory form only contains the date
of the report. The submission of the learned counsel that Rule 45 of the Drugs and Cosmetics Rules,
1945 mandates testing of the sample and furnishing report within 60 days, is only directory in nature
and the violation does not by itself vitiate the report of the Drugs Testing Laboratory. The date on
which the test was conducted and the conditions under which the Tablets were kept, are all matters for
trial and the same cannot be taken into consideration at the stage of quashing a complaint.

9. The next submission made by the learned counsel for the petitioners that the stockist namely Drug
Warehouse, Tamilnadu Medical Services Corporation Ltd., Pudukkotai and the pharmacist,
Government Hospitals, Arandhangi, did not keep the Tablets in accordance with the stipulation
provided for storage, is also a factual question which can be gone into only at the time of trial and not
at the stage of considering the petition to quash under Section 482 of Cr.P.C.

10. The main submission made by the learned counsel for the petitioners that the petitioners have lost a
valuable defence provided to them under Section 24(3) and Section 24(4) of the Act, is also not
sustainable for the following reasons;

[Link] petitioners received the show cause memo dated 06.01.2018 along with the report of the
Government Analyst and also a portion of sample drawn for analysis. The petitioners ought to have
given a reply along with the request to send a sample to the Central Drugs Laboratory, within 28 days
from the date of the receipt of the copy of the letter along with the report, as per Section 25(3) of the
Act. In this case, the petitioner has given a reply dated 14.02.2018 to the respondent. Even though the
reply is dated 14.02.2018, it was actually sent through post only on 01.03.2018 and the same is evident
from the specific averment made in the complaint. Therefore, the reply itself was sent beyond 28 days
from the date of the receipt of the show cause memo and the report. Even in the reply, the petitioners
have not specifically expressed their intention to send the sample to the Central Drugs Laboratory
within 28 days of the receipt of the show cause memo and report. Admittedly, the shelf life of the Drug
was up to March 2018 and the petitioners could have easily sought for sending the sample to the
Central Drugs Laboratory to get an independent report and sustain their defence. However, for reasons
best known to the petitioners, they neither gave the reply within 28 days nor did they express their
intention to send the sample for test to the Central Drugs Laboratory. The petitioners having failed to
do so, cannot make a complaint against the respondent now, after the shelf life is already over in March
2018 itself. The petitioners in fact failed to take advantage of valuable right available to them under
Section 25(3) of Act.

12. The Judgment cited by the learned counsel for the petitioners in Tata Chemicals Limited .Vs.
Commissioner of Customs (Preventive), Jamnagar reported in (2015) 11 SCC 628 will not have any
application in the present case as that was case under the Customs Act, where the samples drawn were
not in accordance with the stipulation and therefore, the Hon'ble Supreme Court held that the
Department cannot rely upon the test report in order to apply a particular notification to the product in
question.

13. The next Judgment relied by the learned counsel for the petitioner, is Northern Minerals Limited
and Others .Vs. Rajasthan Government and Another reported in (2016) 12 SCC 298, which was a case
under the Insecticides Act, 1968. In the said Act, there is a provision under Section 24, which is very
similar to provision under Section 25 of the Act. By interpreting the said provision, the Hon'ble
Supreme Court has held that indication of the intention to send the sample to the Central Laboratory is
not only available to the person from whom the sample was drawn, but also to any other accused
person against whom the proceedings are initiated. Therefore, if the ratio is applied in the present case,
even though the sample was drawn from the Government Hospital, Aranthangi, since the respondent
proceeded against the petitioners in their capacity as manufactures, the petitioners also had the right to
express their intention to send the sample Drugs to the Central Drugs Laboratory, within 28 days of the
receipt of the the report. However, the petitioners failed to exercise this right. Therefore, the Judgment
cited by the learned counsel for the petitioners will not help the case of the petitioners.

14. The other Judgments cited by the learned counsel for the petitioners are all cases, where this court
has taken a view that the delay in filing the complaint after the shelf life of the Drug, will also vitiate
the complaint. In all those cases, it is seen that the petitioners had expressed their intention to send the
sample to the Central Drugs Laboratory and by then, the shelf life of the Drug came to an end.
Therefore, this court found that the petitioners have lost their valuable right. However in this case, the
petitioners had such a right very much available, when they received the show cause memo and the
report and the petitioners failed to give a reply nor expressed their intention to send the sample within
28 days to the Central Drugs Laboratory. Therefore, those Judgments will not apply to the present case.

15. This court in Laborate Pharmaceuticals India Ltd., rep. by its Director Ajay Bhatia and Others .Vs.
State, rep. by the Drugs Inspector, Tondiarpet ? II range, Zone-I, Chennai 600 006 reported in (2016) 4
MLJ (Crl) 110 had an opportunity to deal with a case which was similar to the present case. The
relevant portion of the Judgment is extracted here under:

(i) On observing the label on the subject drug, the respondent found that it has been manufactured by
Laborate Pharmaceuticals India Ltd. (A1). Therefore, the respondent issued a show cause notice on
22.03.2012 to Laborate Pharmaceuticals India ltd. (A1), enclosing a copy of the Analyst's report, as
required under Section 25(2) of the Act. Laborate Pharmaceuticals India Ltd.(A1) sent a reply letter
dated 14.05.2012 acknowledging receipt of the show cause notice on 04.04.2012. In the reply to the
show cause notice, Laborate Pharmaceuticals India Ltd. (A1) contended that they have to licence to
manufacture the subject drug, but, the drug would not have been properly stored by the retailer and at
the Government laboratory.

(ii) It may be necessary to state here that Laborate Pharmaceuticals India Ltd. (A1) did not elect to
adduce evidence controverting the Government Analyst's report, as required under Section 25(3) of the
Act.

(iii) As stated above, as per Section 25(3) of the Act, if any person wants to adduce evidence
controverting the Government Analyst's report, a request should be made within 28 days from the date
of receipt of the show cause notice. In this case, the show cause notice was issued on 22.03.2012 and in
the reply letter dated 14.05.2012, Laborate Pharmaceuticals India ltd. (A1) did not elect to adduce
evidence controverting the Government Analyst's report and only in the communication dated
13.09.2012, they asked for sending the sample to the Central Laboratory. Hence, a belated request well
beyond 28 days fixed by the statute cannot be entertained.
(iv) Since the reply given by Laborate Pharmaceuticals India Ltd. (A1) was not satisfactory, the
respondent obtained sanction from the Government and filed a complaint against Laborate
Pharmaceuticals India Ltd. (A1) and their Directors for various offences under the Act, challenging
which the petitioners/accused are before this Court.

(v) As regards the other submission of the learned counsel for the petitioners that the petitioners have
lost their valuable right in having second sample sent to the Central Laboratory for re-analysis, this
Court is of the considered view that the accused had not elected to repudiate the Government Analyst's
Report within 28 days as required under Section 25(3) of the Act. Had the accused elected to adduce
evidence controverting the Government Analyst's report in terms of the Act, there can be force in the
submission of the learned counsel for the petitioners. In this case, the complaint has been filed on
28.11.2012 before the expiry of the shelf life of the drug, which, even according to the petitioner is
three years.

16. The Judgment cited supra, will have a direct application to the present case. This Court has held
that if the accused person did not elect to repudiate the Government Analyst's report within 28 days, as
required under Section 25(3) of the Act and has not elected to adduce evidence controverting the
Government Analyst's report by getting the sample tested by the Central Drugs Laboratory, the accused
person cannot be permitted to turn around and complain before this Court that the private complaint
was filed by the respondent after the shelf life of the Drug. The prosecution under this Act is not a lis
between two private individuals, but, is intended for securing and safeguarding public health. When
substantiated Drug is manufactured and supplied in the market, Courts must be doubly careful dealing
with such cases. Therefore, unless a very strong ground is made out by quoting mandatory statuary
violation, Courts should not quash the complaint at the threshold stage. It is always open to the
petitioners to establish their defense, during the course of trial.

16. This court does not find any ground to quash the proceedings in exercise of its powers under
Section 482 of Cr.P.C. Accordingly, this Criminal Original Petition stands dismissed. Consequently,
connected miscellaneous petitions are closed.

17. The learned counsel for the petitioner would submit that the second respondent is a resident of
Uttharhand, therefore his personal appearance may be dispensed with. Accepting the said submission
the presence of second petitioner before the trial court shall be dispensed with on the condition that he
shall be present at the time of questioning under section 313 of Cr.P.C, at the time of passing
judgement. The petitioner shall be represented by a counsel during all hearings and the counsel
representing the petitioner will cross examine the prosecution witness on the day when they are
examined in chief.

To

[Link] Inspector, Aranthangi Range, O/o, the Asst. Director of Drugs Control, Thanjavur Zone,
Thanjavur-1.

[Link] Judicial Magistrate, Aranthangi.