Brief synopsis regarding petition u/s 482 of CrPC for Ferrotone Syrup

Batch No. FRLS – 1007 M/D :- 12/2015, E/D :- 04/2017

1. PROCEDURAL LAPSE On 27.01.2017 The sample was drawn by the drugs

inspector, Himachal Pradesh from Civil Hospital, Paonta Sahib – Himachal Pradesh.
On 06.02.2017 sample was sent to Government Analyst, Himachal Pradesh for test
analysis. On 13.02.2017 the sample was received by Government Analyst, Himachal
Pradesh and was reported on 26.04.2017 as NSQ after a gap of 72 days which was
against the stipulated period of 60 days as per rule 45 of the Drugs Rules 1945. That it
is a clear procedural lapse on the part of Government Analyst for not complying the
testing period of 60 days as prescribed in the said rules thereby Vitiating the right of
the manufacturer to get it re-tested prior to its expiry as per the mandate of section 25
(3) & (4) of Drugs and Cosmetics Act 1940.

2. METHOD OF ANALYSIS NOT AS PER STP OF MANUFACTURER

i). On 26.04.2017, the Government Analyst, Himachal Pradesh stated the sample of
Drug as NSQ in respect of Assay of Folic Acid found to be 58.8% of the label claim.
The analysis of the sample was carried out by Government Analyst, Himachal Pradesh
by Microbiological Assay as stated by him in Form – 13 Dated 26.04.2017. Ferrotone
Syrup is a PATENT AND PROPRIETARY Drug and the method of analysis is
required to be obtained and tested as per the standard procedure followed by the
manufacturer. The Government Analyst, Himachal Pradesh had neither obtained the
procedure for testing required for testing of the said Drug from the manufacturer nor
requested the Drugs inspector – H.P for supply of the method of analysis for Ferrotone
Syrup. The method adopted by the manufacturer is by HPLC and not by
Microbiological Testing.
ii). On 25.10.2017 the Appellant, on receipt of the test report on Form – 13 from the
Drugs Inspector HP, after the expiry of the Drugs on 30.04.2017, asked the Drugs
Inspector, Himachal Pradesh to kindly ask the Government Analyst, Himachal
Pradesh to clarify as to why the sample of Drug, which is PATENT AND
PROPRIETARY Drug, not tested as per HPLC and not by Microbiological Method in
accordance to the method of analysis of the manufacturer.
iii). The State Drugs Controller vide its letter dated 23.04.2018 address to the
concerned DI also agreed that as per DCGI guidelines for fixed dose combination
which are not official in pharmacopeia, the specific testing procedure (STP) should be
taken from the concerned manufacturer and as per the STP of the firm the analysis of
Folic Acid should have been by the HPLC method instead of the Microbiological
method. Thus the screening committee was of the opinion that before considering the
matter further, the Drug Inspector to be directed to take comments of GA on the reply
of the manufacturer. The Screening Committee of the Drugs Control Department HP
asked the concerned DI to take up the matter with the Government Analyst and submit
the case again after taking comments from Government Analyst as per manufacturer’s
letter.
3. Regarding conclusivity of Government Analyst report.
According to section 25 of the Drugs & Cosmetics Act 1940
Reports of Government Analysts.—(1) The Government Analyst to
whom a sample of any drug[or cosmetic] has been submitted for test or
analysis under sub-section (4) of section 23, shall deliver to the
Inspector submitting it a signed report in triplicate in the prescribed
form.
(2) The Inspector on receipt thereof shall deliver one copy of the report
to the person from whom the sample was taken 4 [and another copy to
the person, if any, whose name, address and other particulars have
been disclosed under section 18A], and shall retain the third copy for
use in any prosecution in respect of the sample.
(3) Any document purporting to be a report signed by a Government
Analyst under this Chapter shall be evidence to the facts stated therein,
and such evidence shall be conclusive unless the person from whom the
sample was taken [or the person whose name, address and other
particulars have been disclosed under section 18A] has, within twenty-
eight days of the receipt of a copy of the report, notified in writing the
Inspector or the Court before which any proceedings in respect of the
sample are pending that he intends to adduce evidence in
controversion of the report.
(4) Unless the sample has already been tested or analysed in the
Central Drugs Laboratory, where a person has under sub-section (3)
notified his intention of adducing evidence in controversion of a
Government Analyst‘s report, the Court may, of its own motion or in its
discretion at the request either of the complainant or the accused,
cause the sample of the drug [or cosmetic] produced before the
Magistrate under subsection (4) of section 23 to be sent for test or
analysis to the said Laboratory, which shall make the test or analysis
and report in writing signed by, or under the authority of, the Director
of the Central Drugs laboratory the result thereof, and such report
shall be conclusive evidence of the facts stated therein.
(5) The cost of a test or analysis made by the Central Drugs
Laboratory under sub-section (4) shall be paid by the complainant or
accused as the Court shall direct.
(i) The Government Analyst Report sent to the manufacturer after its expiry looses its
conclusiveness as provided u/s 25(3) &(4) for the reasons that
(a) method of analysis followed by GA was wrongly adopted and
carried the testing by Microbiological Method instead of HPLC viz the
STP of the manufacturer.
(b) The expert screening committee of Drugs Controller HP
(Prosecution) had asked the DI for comment from GA for anomaly as
stated in para (a) above, but without getting any comments from GA
had issued the prosecution sanction.
(c) The entire prosecution case is based on the GA report which is not
conclusive in nature hence cannot be considered as an evidence against
the manufacturer.
In the Medicament Biotech Limited Vs. Rubina Bose, The Hon’ble Apex Court held,
“that the valuable rights of the appellant to adduce evidence to controvert facts
provided in the report of the Government AnalysT, the fourth sample with the
Magistrate had not been sent for re-analysis. The observations in Amery
Pharmaceuticals's case (supra) are also to the same effect. We find that the aforesaid
interpretation supports the case of the appellants inasmuch they had been deprived of
the right to have the fourth sample tested from the Central Drugs Laboratory. It is also
clear that the complaint had been filed on the 2nd July 2002 which is about a month
short of the expiry date of the drug and as such had the accused appellant appeared
before the Magistrate even on 2nd July 2002 it would have been well might
impossible to get the sample tested before its expiry. In the affidavit filed to the
petition by Dr. D. Rao, Deputy Drugs Controller, and in arguments before us, it has
been repeatedly stressed that the delay in sending of the sample to the Central Drugs
Laboratory had occurred as the appellant had avoided service of summons on it till 9th
May 2005. This is begging the question. We find that there is no explanation as to
why the complaint itself had been filed about a month before the expiry of the shelf
life of the drug and concededly the filing of the complaint had nothing to do with the
appearance of the accused in response to the notices which were to be issued by the
Court after the complaint had been filed. Likewise, we observe that the requests for
retesting of the drug had been made by the appellant in August/September 2001 as
would be clear from the facts already given above and there is absolutely no reason as
to why the complaint could not have been filed earlier and the fourth sample sent for
retesting well within time. We are, therefore, of the opinion that the facts of the case
suggest that the appellants have been deprived of a valuable right under Section 25(3)
and 25(4) of the Act which must necessitate the quashing of the proceedings against
them.
In view of the said judgment, keeping in view of the facts of our case we have been
deprived of a valuable right under Section 25(3) and 25(4) of the Act by not sending
the sample for re-testing at CDL Kolkata as it was reported after its expiry moreover
the comments of the Government Analyst could not be obtained regarding the method
of analysis in-spite of instructions from screening committee of Drugs Controller HP
and 3 reminders of the DI (dated 05.05.2018, 04.10.2018, 20.11.2018) to the
Government Analyst who had not replied anything to these communications and in-
spite of that very lacunae the screening committee on 02.02.2020 had ordered for
prosecution sanction to the manufacturer without considering the appalling flaws in
the entire case.
4. Regarding Section 34-
Offences by companies:—(1) Where an offence under this Act has
been committed by a company, every person who at the time the
offence was committed, was in charge of, and was responsible to the
company for the conduct of the business of the company, as well as the
company shall be deemed to be guilty of the offence and shall be liable
to be proceeded against and punished accordingly:
Provided that nothing contained in this sub-section shall render any
such person liable to any punishment provided in this Act if he proves
that the offence was committed without his knowledge or that he
exercised all due diligence to prevent the commission of such offence.
(2) Notwithstanding anything contained in sub-section (1), where an
offence under this Act has been committed by a company and it is
proved that the offence has been committed with the consent or
connivance of, or is attributable to any neglect on the part of, any
director, manager, secretary or other officer of the company, such
director, manager, secretary or other officer shall also be deemed to be
guilty of that offence and shall be liable to be proceeded against and
punished accordingly:
Explanation:—For the purposes of this section—
(a) ―company means a body corporate, and includes a firm or other
association of individuals; and
(b) ―director in relation to a firm means a partner in the firm
(i). According to section 34 there are two requirements before a person is
prosecuted as the director /partner of a company/firm. The requirements are
that such person should be (a) person in charge (b) should be responsible for
day to day affairs of the company. These two twin requirements had been held
by the Apex Court in various decision before such directors are prosecuted
under section 34 of the Drugs & Cosmetics Act, 1940.
In the state of Haryana vs. Brijlal Mittal, the Apex Court has held as under it
is thus seen that the vicarious liability of a person for being prosecuted for an
offence committed under the act by a company arises if at the material time he
was incharge of and responsible to the company for the conduct of business .
Simply a person is a director of the company it does not necessarily mean that
he fulfills both the above requirement so as to make him liable.
Conversely, without being a director a person can be incharge of and
responsible to the company for the conduct of its business. From the complaint
in question we , however , finds that except a bald statement that the
respondents were the directors of the manufacturer, there is no other
allegation to indicate, even prima facie , that they were incharge of the
company and also responsible to the company for the conduct of its
business.
Similarly , in Delhi Municipality v. Ram Kishan, MANU/SC/0094/1982 :
1983CriLJ159 while dealing with the applicability of Section 17(1) of the
Prevention of the Food Adulteration Act, 1954, which is in para materia with
Section 34(1) of the Act, on similar facts, this Court observed as under:-

"So far as the Manager is concerned, we are satisfied that from the very nature
of his duties it can be safely inferred that he would undoubtedly be vicariously
liable for the offence, vicarious liability being an incident of an offence under
the Act. So far as the Directors are concerned, there is not even a whisper not
a shred of evidence nor anything to show, apart from the presumption drawn
by the complainant, that there is any act committed by the Directors from
which a reasonable inference can be drawn that they could also be
vicariously liable. In these circumstances, therefore, we find ourselves in
complete agreement with the argument of the High Court that no case against
the Directors (accused Nos. 4 to 7) has been made out ex facie on the
allegations made in the complaint and the proceedings against them were
rightly quashed."
The apex court had held similar views in lalankumar singh vs. State of
Maharastra (Criminal Appeal No. 1757/2022).

(ii). In view of the decided cases of the hon’ble Apex Court cited above, it is
pertinent to refer copy of the complaint filed by the prosecution. On going
through the said complaint, there is not even a whisper or shred of evidence
regarding the director responsibility towards the person incharge and
responsible for the conduct of day to day business of the company. The entire
complaint from Para 1 to para 8 does not disclose even by words or by way of
evidence of the directorial role as provided under section 34 of the Act to bring
them Vicariously liable for the offence disclosed in the complaint.