Citation : 2023 Latest Caselaw 5226 Patna
Judgement Date : 10 October, 2023
IN THE HIGH COURT OF JUDICATURE AT PATNA
CRIMINAL MISCELLANEOUS No.72370 of 2018
Arising Out of PS. Case No.-1005 Year-2004 Thana- SAHARSA COMPLAINT CASE
District- Saharsa
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Kal Sundaran, Son of N. Iyer Subramanian, the then Managing Director of M/S Glaxo Smithkline Pharmaceuticals Limited, having its registered office at M/S 252, Dr. Annie Basant Road, Police Station - Worli, Mumbai - 400026, Maharashtra.
... ... Petitioner/s Versus The State of Bihar ... ... Opposite Party/s ====================================================== Appearance :
For the Petitioner/s : Mr. Ansul, Advocate Mr. Sanjeev Kumar, Advocate Mr. Rajeev Shekhar, Advocate Mr. Prabho Shankar Mishra, Advocate Mr. Akash Pratap Singh, Advocate For the Opposite Party/s : Mr. Sujit Kumar Singh, A.P.P. ====================================================== CORAM: HONOURABLE MR. JUSTICE SATYAVRAT VERMA ORAL JUDGMENT Date : 10-10-2023
Heard learned counsel for the petitioner and learned
A.P.P. for the State.
2. The present quashing application has been filed
seeking quashing of the order dated 27.08.2004 passed in
Complaint Case No. 1005(C) of 2004 whereby the learned Chief
Judicial Magistrate, Saharsa has taken cognizance against the
petitioner of the offence under Section 27(d) of the Drugs and
Cosmetics Act, 1940.
3. Learned counsel for the petitioner submits that in the
nature of allegation as alleged in the complaint, prima facie, it
would manifest that no offence, against the petitioner, is made out. Patna High Court CR. MISC. No.72370 of 2018 dt.10-10-2023
4. Learned counsel for the petitioner submits that the
complainant alleges that on 12.06.2003 the premises of M/s
Popular Agencies, Mahavir Chowk, Saharsa, who holds valid
Drugs Wholesale Licence, was inspected and disposal of drugs
manufactured by Dr. Reddy's Laboratories Ltd. (in short 'Dr.
Reddy') and marketed by M/s Glaxo Smithkline Pharmaceuticals
Limited (in short 'GSK') along with other drugs was stopped by
issuing Form 15 for the irregularities committed as mentioned in
the inspection note. The premise of M/s Popular Agencies was
again inspected on 29.01.2004 and minimum quantity of drug in
question along with other drugs were seized. On 07.07.2003, the
complainant inspected the premises of M/s Shivshakti Medical
Agency, Bangaon Road, Saharsa and disposal of drugs
manufactured by Dr. Reddy and marketed by GSK along with
other drugs was stopped by issuing Form 15. The premises of M/s
Shivshakti Medical Agency, Bangaon Road, Saharsa was again
inspected on 28.01.2004 and minimum quantity of drug in
question along with other drugs were seized. It is next alleged that
the drug, namely, Stibs manufactured by Dr. Reddy and marketed
by GSK were found in the premise of Popular Agencies and
Shivshakti Medical Agency and the expiry date of the drugs were
in between August and September, 2004. Further, alleges that the Patna High Court CR. MISC. No.72370 of 2018 dt.10-10-2023
name and logo of GSK are printed on the label of the drug when
GSK is purchaser and not manufacturer thus the same is in breach
of Drugs and Cosmetics Rules, 1945 (hereinafter referred to as
'the 1945 Rules'). Accordingly, clarification was sought from GSK
by letter dated 15.07.2003, thereafter GSK furnished no
clarification by its letter dated 19.07.2003 with regard to the issue
in question but subsequently furnished clarification by letter dated
20.08.2003 stating that logo of GSK appears on labels of drugs
manufactured by other companies because the product is marketed
by GSK and labelling is mandated as per Rules 96 and 97 of the
1945 Rules. Further, by logo additional information is furnished to
the customers that product is marketed by GSK manufactured by a
company other than GSK under a third party manufacturing
agreement but the product continues to be of the same high quality
and standard that our customers used to. After seeking
clarification, it is alleged that by this act of the GSK and other
companies there is loss to government revenue, as, when they
manufactured drug in their own licence factory or get their product
manufactured in other licencee's factory under loan licence they
have to deposit prescribed amount under the Drugs and Cosmetics
Act, 1940 and Rules 1945 in government account towards licence
fee, inspection fee and additional product approval fee but under Patna High Court CR. MISC. No.72370 of 2018 dt.10-10-2023
third party manufacturing agreement government gets no fee.
Further, when drug is manufactured in their own licence factory
they have certain legal obligation and responsibility but when they
get their product manufactured under third party manufacturing
agreement they are free from those legal obligations thus GSK has
probably resorted to the unfair practice of third party
manufacturing. Further, there is no provision in the 1945 Rules
where name and logo of intended purchaser could appear on
purchased drug, thus Rules 96 and 97 of the 1945 Rules stand
violated which mandates labelling of drugs but label comes within
the purview of manufacture as per Section 3(f) of the Drugs and
Cosmetics Act, 1940 but then GSK is not manufacturer of drug in
question. Further, by labelling it the Doctors and customers get
misled that drug is being manufactured by GSK which violates
Section 17(c) of the Drugs and Cosmetics Act, 1940. Further, GSK
also availed the manufacturing facility of Dr. Reddy to get their
product manufactured under third party manufacturing agreement
but without any legal obligation under 1945 Rules.
5. Learned counsel for the petitioner submits that from
bare perusal of the allegation as alleged in the complaint, it would
manifest that the allegation hinges around the fact that GSK being
purchaser of medicine from Dr. Reddy Laboratories is using its Patna High Court CR. MISC. No.72370 of 2018 dt.10-10-2023
name and logo on the label which is an offence under Rules 96 and
97 of the 1945 Rules, further by this act of GSK the government is
put to loss in terms of revenue, the Doctors and the intending
customers are misled thinking that the drug in question is being
manufactured by GSK when it is not the case and labelling as
incorporated under Rules 96 and 97 of the 1945 Rules comes
within the definition of manufacture as per Section 3(f) of the
Drugs and Cosmetics Act, 1940 when GSK is not the manufacturer
of the drug in question.
6. Learned counsel for the petitioner submits that it
absolutely does not stand to reason that on what basis it is being
alleged in the complaint that the government is put to loss when
the manufacturer of the drug is paying all the requisite fee in terms
of the Act and the Rules. It is further submitted that for the same
drug the government cannot charge twice i.e. once from Dr. Reddy
and thereafter by GSK. It is next submitted that the label on the
drug is clear that the product is being manufactured by Dr. Reddy
Laboratories and is being marked by GSK. It is thus submitted that
it cannot be alleged that the labelling of the drug by using the
name and logo of GSK is being done in order to mislead the
Doctors and the intending customers. It is submitted that GSK is a
very reputed British Company and has its brand name world over Patna High Court CR. MISC. No.72370 of 2018 dt.10-10-2023
and thus would not indulge in any act which would bring disrepute
to the brand. It is further submitted that the logo and the name of
GSK is being used by way of additional information to the
customers that they be sure of the fact that though the drug is
being manufactured by some other company but since it is being
marketed by GSK as such the drug is maintaining the high quality
which is required.
7. Learned counsel for the petitioner submits that the
petitioner in the present application is the Managing Director of
GSK and is not responsible for the day-to-day affairs of the
company. It is further submitted that even the complaint petition
does not specifically allege with regard to the role of the petitioner
in the company at the time of the alleged occurrence as such rigors
of Section 34 of the Drugs and Cosmetics Act, 1940 will not apply,
which is with respect to the offences by companies.
8. Learned counsel for the petitioner next relies on an
order passed by this Court in Cr. Misc. No. 30516 of 2017
(Deepak Shanti Lal Parekh @ Deepak Parekh Vs. The State of
Bihar) to submit that the present case is also similar to the case of
Deepak Shanti Lal Parekh who had moved before this Court in Cr.
Misc. No. 30516 of 2017 and the Court after recording in detail the
submissions of the learned counsel for the petitioner quashed the Patna High Court CR. MISC. No.72370 of 2018 dt.10-10-2023
order of cognizance. It is thus submitted that the submissions made
in Cr. Misc. No. 30516 of 2017 is adopted in the present case also.
9. Learned A.P.P. for the State opposes the present
application.
10. Considering the submissions made by the learned
counsel for the petitioner and taking into consideration the order
dated 10.10.2023 in Cr. Misc. No. 30516 of 2017 and the fact that
in the complaint petition there is no specific allegation with respect
to the petitioner alleging his role in the company at the time of the
occurrence, the order dated 27.08.2004 passed in Complaint Case
No. 1005(C) of 2004 by the learned Chief Judicial Magistrate,
Saharsa whereby cognizance of the offence against the petitioner
has been taken under Section 27(d) of the Drugs and Cosmetics
Act, 1940, is hereby quashed.
11. Accordingly, this application is allowed.
(Satyavrat Verma, J)
Kundan/-
AFR/NAFR N.A. CAV DATE N.A. Uploading Date 13.10.2023 Transmission Date 13.10.2023
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