IN THE HON’BLE HIGH COURT OF JAMMU AND KASHMIR AND LADAKH

AT JAMMU.
CRM(M) No. No. 752 /2022
M.P. No. ______/2022

1. Alkem Laboratries Ltd. V/s U.T. Of Jammu

and
kashmir And Ors.

…PETITIONER …RESPONDENT

IN THE MATTER OF: -

Objections on behalf of
Respondent No. 1 to 3.

MAY IT PLEASE YOUR LORDSHIPS;

The answering respondents most respectfully submit
as under:-

1. That present petition is not

maintainable as petitioner has not approached the trial
court so far to project his grievance in the first
instance. The petitioner is seeking quashment on the
basis of plea which is in the form of defense and which
requires leading of evidence during trial. Thus no
proceedings can be quashed in exercise of inherent
jurisdiction where a plea in the form of defense is
raised without joining the trial and without projecting
the same before the trial court. The present petition on
that score is premature; hence same is liable to be
dismissed.
2. That petitioner admittedly
has entered into a contract of manufacturing of drugs
with East African Overseas and in terms of the said
agreement is a party to the manufacturing of the drug
in question. The petitioner besides being a partner in
the manufacturing process is also selling and stocking
 the drugs in question and is guilty of the offences
punishable U/S 18/27 of the Drugs and Cosmetics Act
1940. Hence petitioner cannot deny his liability under
law when the drug in question has been manufactured
and sold by him in the market. On that score alone
this petition deserves to be dismissed.
3. That the contention of
petitioner as regards Sec-34 is concerned, it is
submitted that the manufacturing company as well as
every person associated with the company as in charge
of the affairs of the company and responsible to the
company for conduct of his business is deemed to be
liable for manufacturing of substandard drug. Since
petitioner never disclosed the details of the
constitution of its company and the persons associated
with the company, answering res No. 2 was left with no
option but to array the managing director of the
company as an accused. It is submitted that
answering respondent No. 2 reserves his right to array
the company as party accused as well, which option is
available with answering respondent No. 2 before the
trial court. As petitioner did not disclose the complete
constitution of the company and never furnished its
documents relating to incorporation, hence in absence
of the requisite information company through
managing director was arrayed as accused. Even this
plea is in the form of defense which can be adjudicated
by the trial court and cannot be raised in these
proceedings for the first time that too without facing
any trial by the petitioners. Hence this petition is
misconceived in law and deserves to be dismissed.
4. That even in terms of clause
2 of Sec 34 the company and its director are free to
prove that the offence is not committed by the
company or by the person in charge by leading cogent
evidence. The honble High Court would not scuttle the
 trial at its initial stage on the asking of the petitioners
in view of the settled legal position that a plea in the
form of defense cannot be taken under Section 482
CrPC as in terms of Sec 19(3) of the Drugs and
Cosmetics Act 1940 not only the manufacturer even
the distributor can take a plea in the form of defense
and has to prove that he acquired the drug from a duly
licensed manufacturer/distributor thereof. Thus
sufficient safeguards under Section 19 and U/S 34 are
available to the manufacturer as well as to the seller to
establish their innocence. Hence where statutory
defenses under the act are available this Honble Court
would not like to exercise inherent jurisdiction to
throttle the proceedings at the initial stage without
asking the accused to face the trial in view of the fact
that the purpose of drugs and cosmetics act 1940 are
not defeated. The Act is enacted with a view to ensure
that in view of the public health and safety strict
provisions are put in place and the courts are alive to
striking balance between individual interest and the
interest of public at large. On that score alone this
petition deserves to be dismissed.
5. That in the instant complaint
one of the accused has died and proceedings have
abated while another accused namely Pradeep Singh
who is arrayed as accused No.2 in the complaint has
pleaded guilty and requested for a lenient view to be
taken. The trial court accepted his plea and imposed
fine of Rs 30,000 with warning for future. The amount
of fine has been realized from the accused Pradeeep
Singh and same has been deposited in the Govt
treasury vide GR No.1453651 dated 17-09-2018 in
terms of order dated 17-09-2018 passed by the trail
court. Thus where one of the accused pleaded guilty
and has been imposed fine, the Honble High Court in
exercise of inherent jurisdiction would not like to
 entertain this petition on the asking of petitioner who
instead of joining the trial court has rushed to this
Honble Court to save himself from the criminal
liability.
6. That even otherwise the
Honble Supreme Court in state of Haryana and others
v/s Choudhary Bhajanlal and Ors reported in 1992 Air
604 as categorically laid down that where
FIR/Complaint discloses an offence inherent
jurisdiction cannot be exercised. In the instant case
the complaint filed by the Drug Inspector in its
uncontroverted form discloses serious offence against
the petitioner hence this petition on that score is not
maintainable and deserves to be dismissed.
7. That answering respondent
lifted the sample on 23-06-2015 from District Hospital
Poonch (Injection Hycortv 100) Form 17 was filled on
spot and the procedural formalities of lifting and
sealing the sample was completed. It is relevant to
submit that the date of manufacture on the injection is
mentioned as 04/2015 and the expiry date is
mentioned as 09/2016. The same was lifted on 23-06-
2015 by the Govt. analyst for District Poonch. He
subjected the injections to various tests and framed
his report on 16-12-2015 which was received by the
drug inspector in the month of January, 2016. After
receipt of the test report in terms of letter dated 02-02-
2016 a communication was addressed to incharge
Store District Hospital Poonch on 02-02-2016 to
disclose the source from where the drug was
purchased. A copy of the letter dated 02-02-2016 is
enclosed herewith and marked as ANNEXURE-I.
8. That the said official replied
the letter on 25-02-2016 disclosing the name of GD
Pharmaceuticals Raghunathpura, Jammu. On verbal
information about GD Pharmaceuticals, a
 communication was also addressed on 04-02-2016 to
GD Pharmaceuticals to disclose the details as
contained in letter dated- 04-02-2016. Copy of the said
letter dated 04-02-2016 is enclosed herewith and
marked as ANNEXURE-II.
9. That the GD Pharmaceuticals
replied on 08-03-2016 disclosing the name of Pardeep
Pharmaceuticals, 111, Raghunathpura, Jammu. It is
submitted that Pradeep Pharmaceuticals replied on
01-04-2016 disclosing the name of Shubham
Enterprises, Pharmaceuticals Distributor, Bye Pass
Road, Channi Rama, Near Hotel Ritz Manohar,
Jammu. On further enquiry from Shubham
Enterprises it was disclosed that he has purchased the
said drug from Alkem Laboratries Limited, Division
Stock Transfer, Dera Bassi, Ware House, Village
Sundra,near Para Bolic Drugs P.O. Mubarakhpur,
Tehsil Dera Bassi Mohali (Punjab) in terms of his letter
dated- 06-05-2016 written in response to the letter
dated 22-04-2016 by the Drug Inspector. It is
submitted that Alkem Laboratries Ltd. disclosed that
the said drug in manufactured by M/s East African
(India Overseas), Plot No. 1, Pharma City Selaqui,
Dehradun, Uttrakhand. On this disclosure the
answering respondent vide his letter dated 01-06-2016
requested MS East African Overseas to furnish detailed
information mentioned in letter dated 01-06-2016. The
petitioner herein was also sent a notice bearing No.
DI/P/07-102016-17 dated 22-04-2016 which was
received by the petitioner on 3rd May 2016 as is
admitted in his letter dated May -06 -2016 which is
enclosed with the complaint as ANNEXURE-M. The
reply of petitioner dated 06-05-2016 is enclosed
herewith and marked as ANNEXURE-III. Petitioner
wrongly written that constitution of firm is enclosed
which infact was never enclosed with the said letter. It
is further submitted that petitioner was made aware of
the drug being substandard and he never requested for
retesting of the drug through an appellate laboratory.
In absence of such request, the test report of Govt.
Analyst becomes final and binding on the petitioner.
The petitioner did not furnish the constitution though
mentioned in his reply incorrectly and cannot reap the
fruit of his own mischief by keeping back the relevant
information of all the partners, Directors of the firm
and then pleading that complaint has not been
properly filed. The answering respondent submits that
he shall move the trial court for arraying the partners
and all the Directors/Person –in-charge as accused
which is a curable defect subject to the permission of
the trial court once the interim order passed by this
Honable Court is vacated. In view of the position
explained the answering respondent submits that the
petitioner cannot be given any premium on these
technical pleas when on specific request he did not
disclose the details of the partners and other persons
connected with the firm/company and did not furnish
the constitution of the firm. Even this plea cannot be
taken seeking quashment of these proceedings unless
the same is taken before the trial court and trial court
has an occasion after sifting the evidence to return a
prima-facie finding on this plea. In the absence of
raising such a plea before the trial court the same
cannot be taken for the first time in these proceedings.
On that score alone the instant petition deserves to be
dismissed.

WITHOUT PREJUDICE TO THE FOREGOING

PRELIMINARY OBJECTIONS, THE PARAWISE
REPLY IS SUBMITTED AS UNDER-
1. In reply to para 1, it is submitted that a company
is arrayed through its managing director hence
once managing director of a company is arrayed
as a party, it cannot be objected by the managing
director that he is not liable in absence of the
company. Section 34 of the Drug and Cosmetics
Act clearly lays down that every person of the
company who at the time of the offence was
committed, was incharge of and was responsible
to the company shall be deemed to be guilty of
the offence. The petitioner has to discharge the
burden in the face of deeming provision that he
is not guilty. It is further submitted that Sec 34
does not provide that in absence of the company
a managing director of the company is not liable.
The contention of petitioner in this regard in
untenable in law and same being incorrect is
denied. The filing of complaint and subsequent
orders by the trial court are correct and admitted
which deserves to be upheld.
2. In reply to para 2 it is submitted that once
petitioner admits that he is involved in the
business of manufacture/supply/distribution
and marketing of pharmaceuticals products, he
is fully liable under the Drugs and Cosmetics Act
1940. The hon’ble court may be pleased to array
the company as accused in view of the larger
public interest involved to check menace of
marketing sub standard drugs or in the
alternative permit the drug inspector to lay
motion before the trial court for arraying the
company as well. Petitioner is banking upon
technicalities to wriggle out of his liability.
Otherwise this plea is not available now once
petitioner company is pleading the cause of its
managing director thereby admitting its
 involvement in liability for the marketing and
manufacturing of substandard drugs.
In reply to the factual background as given in
sub para 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13,
14, 15, 16, it is submitted that same pertains to
lifting of the sample and subsequent proceedings
conducted by the drug inspector, same are not
denied. As petitioner failed to join the trial court
and without availing the same he has rushed to
this Honable Court which course is not available
to him under law, hence this petition deserves
dismissal.
3. In reply to sub para 17, 18, 19 and 20, it is
submitted that same pertains to the
manufacturing contract interse parties indicating
and establishing the fact that petitioner is
associated with manufacturing, stocking and
marketing of the drug in question hence is fully
liable U/S 18/27 of the Drugs and Cosmetics Act
1940. It is further submitted that the details
which has been disclosed in these paragraphs
were never furnished by the petitioner to
answering res No. 2 during the course of
proceedings despite specific request.

Contents of sub para 21 and those of grounds are

replied as under-
1. Contents of ground A are incorrect and denied,
the complaint discloses serious offence against
the petitioner hence this petition deserves
dismissal.
2. Contents of ground B are denied.
3. Contents of ground C are denied. The trial court
after due application of mind has taken
cognizance and issued the process which
deserves to be upheld.
4. Contents of ground D are incorrect and denied. It
is submitted that detailed constitution of the
company was never disclosed/furnished by the
petitioner, hence company was arrayed through
managing director. It is further submitted that if
company is not arrayed in the complaint how can
the company file the present petition. The locus
to file present petition then would be available
only to the managing director and not to the
company, answering respondents pray that the
Honable Court may be pleased to array the
company as accused in the complaint in the
public interest at large or permit the applicant to
lay motion before the trial court to array the
company as well/. This is not an incurable defect
giving rise to the quashment of the proceedings,
the plea is incorrect and denied.
5. In reply to ground E it is submitted that all the
judgments referred to and relied upon by the
petitioners are distinguishable on facts and law
and same are not applicable to the case in hand.
The principle u/s 34 of the Drugs and Cosmetics
Act are different and distinct from the facts of the
case relied upon by the petitioner. Hence the
principles as are culled in Anita Handa are based
on Sec 141 are not applicable when no such legal
bar is engrafted u/s 34 of the Drugs and
Cosmetics Act.
6. Contents of ground F are incorrect and denied,
detailed submissions have been made which
needs no repetition and are reitreated.
7. In reply to ground G it is submitted that specific
averments are made in the complaint which are
sufficient to proceed against the petitioner hence
the plea is incorrect and denied.
8. Contents of ground H are incorrect and denied.
 9. Contents of ground I are incorrect and denied,
detailed investigation has been carried out by
answering respondent No. 2 and based on the
said investigation complaint has been filed.
10. In reply to contents of Ground J and K answering
respondent submits that u/s 34 each person in
whatsoever capacity is associated with the
company is deemed to be liable, hence petitioner
cannot escape his liability.
11. Contents of ground L are denied as same shall be
dealt with during the course of arguments.
12. Contents of ground M and those of sub para 1 to
4 are incorrect and denied except that after lifting
the sample same was sent to testing laboratory
thereafter the petitioner never objected the report of
testing laboratory or souht its retesting, same was
deemed as final. Based on detailed enquiry and the
test report, complaint was filed. It is submitted that
the protection as claimed by the petitioner u/s
19(3) is in the form of a defense which can be
raised before the trial court only as this Honable
Court cannot assume the role of the trial court in
these proceedings.
13. Contents of para N is repetition of the averments
made in the proceeding part which stood fully
replied hence the plea of petitioner is incorrect and
denied.
14. Contents of ground O, P, Q, R, S, T, U, V, W, X, Y,
the answering respondent submits that all the
averments are repetition of the facts pleaded which
are denied. Detailed submissions have been made
in this reply which are adopted as reply to the
averments made in this paragraph to avoid
repetition. The stand taken by the petitioner is
therefore incorrect and denied.
 15. Contents of ground aa, bb, cc, dd, ee, ff, gg, hh,
are incorrect and denied. The answering
respondent submits that petitioner was furnished
the test report and failed to exercise the option of
retesting even this option can be exercised before
the trial court where also petitioner failed to seek
retesting by filing any application before the trial
court intentionally to defeat the complaint by
remaining absent and subsequently by choosing
the filing of present petition even without attending
the trial court ever since filing of the proceedings.
The complaint was filed after completing the
detailed enquiry when sanction to file the complaint
was received. Under law once the report is made
available to the petitioner he can seek retesting by
asking the drug inspector for retesting or even by
approaching the competent court for seeking such
retesting, petitioner failed to do the same and hence
he cannot plead violation of 25(3) or sec 25 (4) of
the Drugs and Cosmetics Act, the averments are
incorrect and denied.
16. Contents of para 22 are denied.
17. Contents of para 23 are denied.
18. Last para by way of prayer is also denied.

In the premises,
It is most humbly prayed, that –
Your lordship may be pleased to dismiss the present petition
with costs.
 RESPONDENTS
THROUGH COUNSEL
Amit Gupta
Additional Advocate General