Rajasthan High Court – Jodhpur
Ganesh Narayan Nayak vs State Of Rajasthan (2025:Rj-Jd:15744) on 21 March, 2025
Author: Farjand Ali
Bench: Farjand Ali
[2025:RJ-JD:15744]
HIGH COURT OF JUDICATURE FOR RAJASTHAN AT
JODHPUR
S.B. Criminal Misc(Pet.) No. 6621/2023
1. Ganesh Narayan Nayak S/o Narayan Vaikunth Nayak,
Aged About 68 Years, R/o- 3 Ashwamegh Part V, Satellite,
Ahmedabad, Gujarat
2. Nitin Kumar Dalsukhray Parekh S/o Dalsukhray
Dharshibhai Parekh, Aged About 62 Years, R/o- 73,
Asopalav Bunglow, Thaltej, Ahmedabad, Gujarat
----Petitioners
Versus
1. State Of Rajasthan, Through Pp
2. Drugs Control Officer, Rajasamand, Office Of Civil
Surgeon Rajasamand, Rajasthan.
----Respondents
Connected With
S.B. Criminal Misc(Pet.) No. 6626/2023
1. M/s Biochem Pharmaceuticals Industries Ltd., (Now
Amalgamated With M/s Zydus Healthcare Limited), 301,
P.n. Kothari Industrial Estate, L.b.s. Marg, Bhandup
(West), Mumbai Through Authorised Signatory Mr. Sachin
Sangare, Aged 47 Years, E-10, Rishikesh Chsl, Evershine
Nagar, Malad West, Mumbai
2. Mayank Jaswantlal Shah S/o Jaswantlal Shah, Aged About
58 Years, R/o- Sudharma 801, Plot-1, Cts 310A, The
Hotkesh Chsl, J.v.p.d. Scheme, Juhu Corner, 5Th Road,
Ville Parle North, Mumbai-400056, Director Of M/s
Biochem Pharmaceuticals Industries Limited (Now
Amalgamated With M/s Zydus Healthcare Limited), 301,
P.n. Kothari Industrial Estate, L.b.s. Marg Bhandup
(West), Mumbai.
3. Shreyansh Jaswantlal Shah S/o Jaswantlal Shah, Aged
About 57 Years, R/o- 318, Avanti Apartment, Flank Road,
Soin, Mumbai-400022, Director Of M/s Biochem
Pharmaceuticals Industries Limited (Noqw Amalgamated
With M/s Zydus Healthcare Limited), 301, P.n. Kothari
Industrial Estate, L.b.s. Marg, Bhandup (West), Mumbai.
4. Shruti Mayank Shah W/o Mayank Shah, Aged About 57
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Years, R/o- Sudharma 801, Plot-1, Cts 310A, The Hotkesh
Chsl, J.v.p.d. Scheme, Juhu Corner, 5Th Road, Ville Parle
North, Mumbai-400056, Director Of M/s Biochem
Pharmaceuticals Industries Limited (Now Amalgamated
With M/s Zydus Healthcare Limited), 301, P.n. Kothari
Industrial Estate, L.b.s. Marg Bhandup (West), Mumbai.
5. Rajinder Kanhiyalal Singhvi S/o Kanhiyalal Singhvi, Aged
About 57 Years, R/o- Sunita Niwas, 78, Swami
Vivekanand Road, Santa Cruz (West) Mumbai-400054,
Director Of M/s Biochem Pharmaceuticals Industries
Limited (Now Amalgamated With M/s Zyduis Healthcare
Limited), 301, P.n. Kothari Industrial Estate, L.b.s. Marg,
Bhandup (West), Mumbai.
6. Suresh Gautamchand Kothari S/o Gautamchand Kothari,
Aged About 54 Years, R/o- 301, Shri Mukti Dham Chs
Limited, Station Road, Opposite Saraswat Bank, Kalwa
(North), Thane, Mumbai-400605 Director Of M/s Biochem
Pharmaceuticals Industries Limited (Now Amalgamated
With M/s Zyduis Healthcare Limited), 301, P.n. Kothari
Industrial Estate, L.b.s. Marg, Bhandup (West), Mumbai.
7. Umesh Lad Competent Person Of M/s Biochem
Pharmaceuticals Industries Limited, (Now Amalgamated
With M/s Zyduis Healthcare Limited), 301, P.n. Kothari
Industrial Estate, L.b.s. Marg, Bhandup (West), Mumbai.
8. Raj Kumar Devram Patil S/o Devram Patil, Aged About 52
Years, Competent Person Of M/s Biochem
Pharmaceuticals Industries Limited (Now Amalgamated
With M/s Zyduis Healthcare Limited), 301, P.n. Kothari
Industrial Estate, L.b.s. Marg, Bhandup (West), Mumbai.
9. M/s Mks Pharma Ltd, Plot No. 114, Huda Industrila
Estate, Sector 59, Faridabad, Haryana Now At 1135
Basement And Ground Floor, Opposite Transport Nagar,
Sector 58, Ballabhgarg, District Faridabad Thorugh Its
Authorized Signatory Mr. Sanjay Gupta, Director.
10. Sanjay Gupta S/o Shri K.l. Gupta, Aged About 61 Years,
R/o- D-947, Chawla Colony, Ballabhgarh, District
Faridabad, Haryana, Director Of M/s Mks Pharma Ltd
1135 Basement And Ground Floor, Opposite Transport
Nagar, Sector 58, Ballabhgarh, District Faridabad.
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11. Manish Gupta S/o Shri K.l. Gupta, Aged About 58 Years,
R/o- D-947, Chawla Colony, Ballabhgarh, District
Faridabad, Haryana, Director Of M/s Mks Pharma Ltd
1135 Basement And Ground Floor, Opposite Transport
Nagar, Sector 58, Ballabhgarh, District Faridabad.
12. Kishori Lal Gupta S/o Late Shri Gulab Chand Gupta, Aged
About 57 Years, R/o- D-947, Chawla Colony, Ballabhgarh,
District Faridabad, Haryana, Director Of M/s Mks Pharma
Ltd 1135 Basement And Ground Floor, Opposite Transport
Nagar, Sector 58, Ballabhgarh, District Faridabad.
13. Aridaman Kumar Jain S/o Shri Shikhar, Aged About 56
Years, R/o- Railway Road, Barot, Baghpat, Up, Director Of
M/s Mks Pharma Ltd 1135 Basement And Ground Floor,
Opposite Transport Nagar, Sector 58, Ballabhgarh, District
Faridabad.
14. Sapna Gupta W/o Shri Manish Gupta, Aged About 58
Years, R/o- D-947, Chawla Colony, Ballabhgarh, District
Faridabad, Haryana, Competent Person Of M/s Mks
Pharma Ltd 1135 Basement And Ground Floor, Opposite
Transport Nagar, Sector 58, Ballabhgarh, District
Faridabad.
----Petitioners
Versus
1. State Of Rajasthan, Through Pp
2. Drugs Control Officer, Rajasamand, Office Of Civil
Surgeon Rajasamand, Rajasthan.
----Respondents
S.B. Criminal Misc(Pet.) No. 108/2024
1. M/s Skymap Pharmaceuticals, B-3, Dev Bhoomi Industrial
Estate, Pohana, Iqbalpur Road, Roorkee District Haridwar
247667 (Uttarakhand) Through Its Authorised
Represetative Arbind Kumar Sharma , Aged 43 Yeaes,
House No. 573, West Amber Talab, Roorkee, Haridwar
2. Sanjay Gupta S/o Shri K.l Gupta, Aged About 49 Years,
D-987 Chawla Colony Ballabhgarh District Faridabad
Haryana Director Of M/s Skymap Pharmaceuticals, B-3,
Dev Bhoomi Industrial Estate, Pohana, Iqbalpur Road,
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Roorkee District Haridwar 247667 (Uttarakhand)
3. Kishori Lal Gupta S/o Late Shri Gulab Chand Gupta, Aged
About 71 Years, D-987 Chawla Colony Ballabhgarh
District Faridabad Haryana Director Of M/s Skymap
Pharmaceuticals, B-3, Dev Bhoomi Industrial Estate,
Pohana, Iqbalpur Road, Roorkee District Haridwar 247667
(Uttarakhand)
4. Arbind Kumar Sharma S/o Harinath Sharma, Aged About
43 Years, Son Of Shri Harihar Nath Sharma House No 573
West Amber Talab, Roorkee Haridwar, Manufacuring
Chemist Of M/s Skymap Pharmaceuticals, B-3, Dev
Bhoomi Industrial Estate, Pohana, Iqbalpur Road, Roorkee
District Haridwar 247667 (Uttarakhand)
5. Naresh Kumar Bahaduriya S/o Shri Chander Mohan
Singh, Aged About 43 Years, R/o House No. 19 Chao
Mandi, Roorkee Haridwar, Manufacuring Chemist Of M/s
Skymap Pharmaceuticals, B-3, Dev Bhoomi Industrial
Estate, Pohana, Iqbalpur Road, Roorkee District Haridwar
247667 (Uttarakhand)
6. Shri Sanjiv Kuamr Saini S/o Surinder Kumar Saini, Aged
About 46 Years, R/o House No. 476/3, Nishant Chao
Mandi Roorkee Haridwar, Analytical Chemist Of M/s
Skymap Pharmaceuticals, B-3, Dev Bhoomi Industrial
Estate, Pohana, Iqbalpur Road, Roorkee District Haridwar
247667 (Uttarakhand)
7. Rahul S/o Shri Chitranjan Singh, Aged About 46 Years,
House No. 767, Chao Mandi Roorkee Haridwar, Analytical
Chemist Of M/s Skymap Pharmaceuticals, B-3, Dev
Bhoomi Industrial Estate, Pohana, Iqbalpur Road, Roorkee
District Haridwar 247667 (Uttarakhand)
----Petitioners
Versus
1. State Of Rajasthan, Through Pp
2. Drugs Control Officer, Rajsamand , Office Of Civil Surgeon
Rajasamand, Rajasthan
----Respondents
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For Petitioner(s) : Mr. Akshay Jain
Mr. Vineet Jain, Sr.Adv. With
Mr. Pankaj Kumar Gupta
Mr. Sanjay Kumar Jain
For Respondent(s) : Mr. N.S. Chandawat, Dy.G.A.
HON'BLE MR. JUSTICE FARJAND ALI
Order
Reportable
21/03/2025
1. These criminal miscellaneous petitions under Section 482
read with Section 483 of the Code of Criminal Procedure,
1973 (Cr.P.C.), have been filed by the respective petitioners
seeking quashing of Complaint No. 158/2017 dated
06.02.2017, titled State of Rajasthan through Drug Control
Officer vs. M/s Life Line Fluid and Drug Store, Rajsamand
and Others, along with all subsequent proceedings arising
therefrom, pending before the learned Chief Judicial
Magistrate, Rajsamand, Rajasthan, on the ground that the
same is illegal and amounts to an abuse of the process of
law.
2. Given the similar nature of allegations, legal issues, and
prayers involved in all the petitions, they are being decided
together through this consolidated order.
3. The origin of the dispute dates back to an inspection
conducted on 30.11.2012 by the Drugs Control Officer
(respondent No. 2) at the premises of M/s Life Line Fluid and
Drug Store, Rajsamand. During the said inspection, a sample
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of the drug “Tab. Glimp-2” (Batch No. BD-11374),
manufactured by M/s Skymap Pharmaceuticals, was
collected for analysis. The Government Analyst, Jaipur, vide
report dated 15.01.2013, declared the sample as not of
standard quality due to non-conformity with the dissolution
test.
4. The distribution chain of the subject drug was traced back
through intermediary distributors, eventually leading to M/s
Biochem Pharmaceuticals Industries Limited (now
amalgamated with M/s Zydus Healthcare Limited), which
marketed the product, and M/s MKS Pharma Limited, a
wholesale license holder. Despite this tracing, the Drugs
Control Officer did not follow the statutory requirement of
sending the sample to the manufacturer for reanalysis under
Section 25(3) of the Drugs and Cosmetics Act, 1940
(hereinafter “the 1940 Act”).
5. The prosecution proceeded to file Complaint No. 158/2017
on 09.01.2017 before the learned Chief Judicial Magistrate,
Rajsamand, under Sections 18(a)(i), 18(a)(vi) read with
Sections 16(i)(a) and 17A, punishable under Section 27(b)(i)
of the 1940 Act. Cognizance was taken vide order dated
06.02.2017.
6. The petitioners before this Court include the following:
CRLMP No. 6621/2023: M/s Biochem Pharmaceuticals
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[2025:RJ-JD:15744] (7 of 14) [CRLMP-6621/2023]Industries Limited – Additional Directors (Non-Executive),
and others.
CRLMP No. 6626/2023: M/s Biochem Pharmaceuticals
Industries Limited, its Directors, competent persons, M/s
MKS Pharma Limited, and its Directors.
CRLMP No. 108/2024: M/s Skymap Pharmaceuticals, its
partners, manufacturing chemists, and analytical chemists.
7. This Court has heard the learned counsels present for the
parties, meticulously perused the records and given its
thoughtful consideration to the facts of the case, the legal
provisions involved, and the judgments cited. The
fundamental issue at hand pertains to the legality of the
complaint and the subsequent proceedings, keeping in view
the statutory provisions under the Drugs and Cosmetics Act,
1940, and the Code of Criminal Procedure, 1973.
8. A comprehensive review of the complaint and the attendant
circumstances reveals a glaring procedural lapse, which
vitiates the very foundation of the prosecution. The principle
of vicarious liability, as embodied under Section 34 of the
Drugs and Cosmetics Act, 1940, fastens liability only upon
those individuals who were in charge of and responsible for
the conduct of the business at the time of the alleged
offence. In the present case, the petitioners, who were
appointed as Additional Directors (Non-Executive) much after
the relevant period, cannot be saddled with criminal liability
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merely by virtue of their designation. The Hon’ble Supreme
Court, in Gunmala Sales (P) Ltd. v. Anu Mehta, (2015)
1 SCC 103, has enunciated the principle that unimpeachable
documents, such as Form-32 and board resolutions, can be
relied upon for quashing criminal proceedings under Section
482 Cr.P.C. The present case falls squarely within the ambit
of this settled legal proposition, as the documents on record
unequivocally establish that the petitioners had no nexus
with the affairs of the company at the time of the alleged
offence.
9. Further, the Hon’ble Supreme Court in Sunil Bharti Mittal
v. CBI, (2015) 4 SCC 609, held that non-executive
directors cannot be held vicariously liable in the absence of
specific allegations regarding their role in the offence. The
same principle was reiterated in Sunita Palita v. Panchami
Stone Quarry, (2022) 10 SCC 152. In the instant matter,
the complaint merely mentions the petitioners as directors of
the company but does not establish their involvement in the
alleged offence. The absence of any substantive allegation or
material indicating their active participation renders the
prosecution unsustainable in law.
10. Additionally, the limitation aspect cannot be ignored.
The alleged offence was detected on 15.01.2013, yet the
complaint was filed only on 09.01.2017, beyond the three-
year statutory limitation prescribed under Section 468 Cr.P.C.
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for offences punishable under Section 27(d) of the 1940 Act.
The Hon’ble Supreme Court, in Cheminova (India) Ltd. v.
State of Punjab, (2021) 8 SCC 818, while dealing with
the Insecticides Act (a statute pari materia to the Drugs and
Cosmetics Act, 1940), held that prosecution beyond the
limitation period is barred. The present case falls squarely
within this legal framework, rendering the continuation of the
proceedings against the petitioners legally untenable.
11. Another critical aspect pertains to the failure of the
Drugs Control Officer to comply with the statutory
requirement under Section 25(3) of the 1940 Act, which
mandates sending a portion of the sample to the
manufacturer for reanalysis in case of a disputed report. The
Hon’ble Supreme Court in Medicamen Biotech Ltd. v.
Rubina Bose, (2008) 7 SCC 196, categorically held that
non-compliance with this statutory mandate vitiates the
entire prosecution. In the present case, despite procedural
irregularities and non-adherence to mandatory requirements,
the complaint was filed and cognizance was taken, which is a
serious lapse on the part of the prosecution.
12. Moreover, the statutory protection under Section 19(3)
of the 1940 Act, which absolves persons other than the
manufacturer from liability if the drug was purchased from a
duly licensed entity and stored in the same condition, has
been disregarded. The Hon’ble Supreme Court in Kisan Beej
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Bhandar v. Chief Agricultural Officer, 1990 Supp SCC
111, while interpreting a pari materia provision under the
Insecticides Act, reiterated this protection for wholesalers
and retailers. The petitioners, being mere marketers and
distributors, fall within the purview of this statutory
safeguard. Thus, their prosecution is not only unwarranted
but also a clear abuse of the process of law.
13. Furthermore, it is evident from the record that the
learned Magistrate failed to conduct a mandatory inquiry
under Section 202 Cr.P.C. before issuing process, despite the
petitioners residing outside the court’s jurisdiction. The
Hon’ble Supreme Court in National Bank of Oman v.
Barakara Abdul Aziz, (2013) 2 SCC 488, and Abhijit
Pawar v. Hemant Madhukar Nimbalkar, (2017) 3 SCC
528, has emphasized that an inquiry under Section 202
Cr.P.C. is imperative in such cases. The failure of the learned
Magistrate to adhere to this mandatory requirement renders
the summoning order legally unsustainable.
14. Additionally, the Government Analyst’s report itself
indicates that the drug in question failed the dissolution test
but had an active ingredient within the standard limits. The
Guidelines issued by the Central Government under Section
33-P of the 1940 Act classify such defects as minor, which do
not warrant prosecution under Section 27(b)(i). The Hon’ble
Supreme Court in Laborate Pharmaceuticals India Ltd.
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v. State of Tamil Nadu, (2018) 15 SCC 93, has held that
where minor defects are noted, initiation of prosecution is
impermissible.
15. In the present case, the drug’s active pharmaceutical
ingredient (API) was found to be within the prescribed
standards, and the only deviation was in the dissolution rate.
A delayed dissolution does not render the drug spurious or
useless; it merely implies a slower release of the active
content, which still remains effective. The therapeutic
efficacy of the drug is not entirely negated by such a delay.
Dissolution rates can be influenced by several factors,
including the quality of excipients, manufacturing processes,
temperature control, and climatic conditions during
production and storage. The presence of the correct active
ingredient in the specified quantity is the primary factor in
determining a drug’s standard quality. If the core content of
the drug remains intact and effective, classifying it as
substandard, spurious, or useless would be legally and
scientifically untenable.
16. The mechanical approach of the prosecution in filing
the complaint, without considering the nature of the defect
and its actual impact on drug efficacy, further substantiates
the contention that the proceedings are an abuse of the
process of law.
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17. The complaint was filed much after the expiry of the
shelf life of the drug, thereby frustrating the valuable right of
the petitioners under Sections 25(3) and 25(4) of the 1940
Act to seek retesting. The Hon’ble Supreme Court in State
of Haryana v. Brij Lal Mittal, (1998) 5 SCC 343, and
State of Haryana v. Unique Farmaid (P) Ltd., (1999) 8
SCC 190, has consistently held that when the right to
retesting is denied due to the expiry of the drug, the
prosecution is rendered null and void. The present case is no
exception, as the petitioners have been deprived of their
statutory right due to an unjustifiable delay in filing the
complaint.
18. In light of the aforesaid discussion, this Court finds that
the entire prosecution is vitiated by multiple legal infirmities,
including non-compliance with mandatory procedural
safeguards, lack of vicarious liability, expiry of limitation, and
statutory protection available to distributors and marketers.
The continuation of the proceedings would, therefore,
amount to a gross abuse of the process of law.
19. Accordingly, the present petitions are allowed.
20. Furthermore, it is imperative to clarify that the
quashing of proceedings is not limited to the petitioners
before this Court but shall also extend to all those who are
similarly placed but have not approached this Court. It would
be an exercise in futility to require such individuals to
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separately seek the same relief when the legal infirmities
affecting the complaint are identical in their case as well.
Judicial propriety demands that similarly situated persons
should not be subjected to unnecessary litigation and
procedural rigmarole when the very foundation of the
prosecution is untenable.
21. The prosecution cannot be permitted to proceed
selectively against some individuals while awaiting others to
approach the Court for relief. Such an approach would lead
to unnecessary harassment and prolonged legal proceedings,
compelling individuals to endure procedural hardships
despite the evident illegality in the complaint. The Court
cannot allow a scenario where individuals, facing the same
legal infirmity, are left with no choice but to initiate fresh
litigation, engage legal counsel, and await case listings
merely to obtain an order identical to the present one.
Justice must be dispensed in a manner that prevents such
avoidable hardship and ensures uniform application of legal
principles.
22. The essence of justice lies in ensuring that individuals
are not subjected to unwarranted litigation, compelling them
to engage in avoidable legal battles. The legal system exists
to dispense justice, not to create a situation where litigants
are burdened with repeated procedural hurdles. Accordingly,
all proceedings arising from Complaint No. 158/2017,
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pending before the learned Chief Judicial Magistrate,
Rajsamand, stand quashed in their entirety, leaving no scope
for further continuation against any individual.
23. In view of the above, the learned Trial Court shall treat
the proceedings as quashed and formally close the case. No
further steps shall be taken in pursuance of the quashed
complaint. The file shall be consigned to the record.
24. The stay petitions and all pending applications, if any,
stand disposed of accordingly.
(FARJAND ALI),J
100-Mamta/-
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