Bombay High Court
Sandeep V Bambolkar And Others vs The State Of Maharashtra on 26 April, 2023
Bench: S. G. Mehare
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IN THE HIGH COURT OF JUDICATURE AT BOMBAY
BENCH AT AURANGABAD
CRIMINAL REVISION APPLICATION NO. 292 OF 2019
1. Mr. Sandeep V. Bambolkar,
Age Major, Occu. Service,
R/o. 901, Tiara Tower, Central Avenue,
Santacruz West, Mumbai-400054
2. Mr. Pramod G. Bagi,
Age Major,Occu. Service,
R/o. Kasliwal Prangan, Opp. Garkheda
Stadium, Ulkanagari, Aurangabad
3. Mr. Nitin C. Datar,
Age Major, Occu. Service,
R/o. E-1, Chanyaka Puri, Shahanurwadi,
Aurangabad
4. Mr. N. A. Joshi,
Age Major, Occu. Service,
R/o. Girija Shankar Vihar,
Behind Best Price Mall, Satara,
Aurangabad
5. Mr. M. R. Bharaswadkar,
Age Major, Occu. Service,
R/o. D-12, Kasliwal Tarangan,
Padegaon, Aurangabad
6. Mr. U. A. Naik,
Age Major, Occu. Service,
R/o. Akruti Enclave, Flat No.B-11,
Khadkeshwar, Aurangabad
7. Indoco Remedies Limited
through it's Authorized officer,
B-20, MIDC, Waluj, Aurangabad .. Applicants
(Accused)
Versus
The State of Maharashtra
through Drug Inspector
Food and Drug Administration
Ramkrushna-Nagar, Vasmat Road,
Parbhani .. Respondent
::: Uploaded on - 26/04/2023 ::: Downloaded on - 27/04/2023 19:06:53 :::
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Mr. Shailesh S. Chapalgaonkar, Advocate for Applicants;
Mr. S. P. Deshmukh, A.P.P. for Respondent/State
CORAM : S. G. MEHARE, J.
Reserved on : 28.03.2023
Pronounced on : 26.04.2023
JUDGMENT
1. Rule. Rule made returnable forthwith. By consent of the
parties, heard finally.
2. The applicants have impugned the order below Exhibits-27
and 28 declining discharge, in Special (Drug) Case No.2 of 2018, of
the learned Additional Sessions Judge-3, Parbhani, dated
29.08.2019.
Facts:
3. Applicant No.7 is a pharmaceutical company that
manufactures Viscid Gel (the tested drug). The remaining
applicants are and were the employees of applicant No.7. They sell
their drugs through their agents and shopkeepers throughout the
State. The respondent is the authority controlling and regulating
the drugs.
4. On 29.06.2015, the then Drugs Inspector visited M/s. Sunil
Enterprises, Dr. Hedgewar Marg, Parbhani, and draw the drug
sample in dispute. On 29 June 2015, the Drugs Inspector sent one
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sealed sample of the drug to the Government Analyst as per the
procedure under the Cosmetics and Drugs Act and the Rules. The
manufacturing date of the said drug was 10/2014, and its shelf life
was to expire on 09/2016. After testing the sample vide its report
dated 30 November 2015, the Analyst declared the said drug as
"Not of Standard Quality" because "the sample does not comply
with USP 37 requirements for Microbial Enumeration Test". On 4
December 2015, the Drugs Inspector received the original copy of
the analysis report in form XIII in triplicate from the Analyst.
Thereafter, some procedures were done, and vide letter dated 4 th
December 2015, applicant No.7 was informed that the drug was
not of standard quality and asked to comply with the directions in
the said letter. However, the said letter does not mention the
Drugs Inspector had filed a complaint. On 30 November 2015, the
Drugs Inspector filed a complaint in the Court of Chief Judicial
Magistrate, Parbhani. He, accordingly, issued a process on 21
September 2016. The applicants appeared in Court and filed their
respective discharge applications.
5. The learned counsel for the applicants would argue that Rule
45 of the Drugs and Cosmetic Rules, 1945 has not been strictly
complied with, and the delay in testing the sample was not
explained. Therefore, the right of the applicants to get the sample
tested through the Court had been limpidly denied. Hence, the
complaint would not stand. The complaint has been lodged
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belatedly, knowing well the expiry date of the shelf life of the drug
in question. Therefore, the applicants have lost their right under
Sections 25(3) and 25(4) of the Drugs and Cosmetics Act 1940 due
to the delay in filing the complaint. On this legal aspect, the
applicants are liable to be discharged. However, the learned
Additional Sessions Judge, Parbhani, did not consider these legal
aspects and erroneously passed the impugned order. It has also
been erroneously observed that the supplier of applicant No.7 did
not convey to the Drugs Inspector within 28 days of the receipt of
the copy of the report that he intends to adduce evidence in
contravention of the report. Its supplier did not avail of that
opportunity. For non-availing this opportunity, the Government
Analyst's report before this Court needs to be treated as
conclusive. To bolster his arguments, the learned counsel for the
applicants relied on the case of (i) Medicamen Biotech Limited
and another Versus Rubina Bose, Drug Inspector, (2008) 7
Supreme Court Cases 196 and (ii) Quixotic Healthcare and
Others Versus State of Maharashtra and others, 2020 All
M.R. (Cri) 1880.
6. Per contra, the learned A.P.P. for the State argued that there
is no question, affecting the rights as per Sections 25(3) and 25(4)
of the Cosmetic and Drugs Act arise as Section 25(3) has not been
complied with. The impugned order is well-reasoned, legal, proper
and correct. There is sufficient evidence to proceed against the
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applicants and to frame the charges. He prayed to dismiss the
application.
7. A very short question falls for consideration, whether Rule 45
of the Drugs and Cosmetic Rules, 1945 was followed and the
applicants have lost their rights available under Sections 25(3) and
25(4) of the Drugs and Cosmetics Act, 1940.
8. Rule 45 of the Drugs and Cosmetics Rules, 1945 reads thus:
"Duties of Government Analysts.--
(1) The Government Analyst shall cause to be analysed or
tested such samples of drugs 1 [and cosmetics] as may be
sent to him by Inspector or other persons under the
provisions of Chapter IV of the Act and shall furnish reports
of the results of test or analysis in accordance with these
rules [within a period of sixty days of the receipt of the
sample:
Provided that where it is not possible to test or analyse the
sample within the specified period, the Government Analyst
shall seek extension of time from the Government giving
specific reasons for delay in such testing or analysis.]
(2) A Government Analyst shall from time to time forward to
the Government reports giving the result of analytical work
and research with a view to their publication at the
discretion of Government."
9. The above rule is specific that the Government Analyst has
to test the samples within sixty days of the receipt of the sample.
The samples were seized on 29 June 2015 and sent to the
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Government Analyst on 4 July 2015. The testing report was
received on 14.11.2016. The copy of the test report dated 30
November 2015 placed on record reveals that the Analyst had
received the samples on 04.07.2014. The Analyst knew the expiry
date was 9/2016. The complaint was lodged on 20.09.2016, and in
September itself sample expired. Considering these dates, it is
apparent that the drug was not tested within sixty days of
receiving the samples.
10. Sections 25(3) and 25(4) of the Drugs and Cosmetics Act
1940 give the accused a right to test the drugs again. The Drugs
inspector was well aware, the shelf life of the sample drug was to
expire in September 2016, and he filed the complaint in the same
month. After filing the complaint, the applicants appeared in Court
as per the process in March 2017. There is no explanation for why
the complaint was filed in the same month, the shelf life of the
drug was to expire. There is absolutely no reason why the
complaint was not filed earlier, and the fourth sample was sent for
testing well within time. These facts suggest that the right of the
applicants to seek the test of the fourth sample has been taken
away. In view of the facts of the case, the case laws relied upon by
the applicants are squarely applicable.
11. Every person involved in the drug business has a right to
challenge the Government Analyst report seeking the remedy
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available under the Law by sending the fourth sample through the
Court for testing. However, here is the case that the sample was
not tested within sixty days of its receipt' therefore, the possibility
of an incorrect result like "not of standard quality" cannot be ruled
out.
12. Appreciating the facts of the case as discussed above and
examining the reasons recorded by the learned Additional Sessions
Judge-3, Parbhani, this Court is of the view that the learned
Additional Sessions Judge-3, Parbhani did not consider the relevant
provisions of Law and came to the erroneous conclusion. In the
facts and the circumstances, even if the documents before the
Court are considered as it is, the prosecution would not be able to
prove the crime against the accused. The offences under the
Drugs and Cosmetics Act are technical. Hence, time has a
significant importance. The process was supposed to be done in a
prescribed or scheduled time. The rules and provisions of the Act
have not been followed strictly. Therefore, the statutory rights of
the accused given under the said Act have been prima facie
affected. In view of that matter, the Court is of the view that the
applicants deserve the discharge. For these reasons, the Court
believes that the impugned order warrants interference. Hence,
the following order:-
ORDER
i) The criminal revision application is allowed.
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ii) The order below Exhibit-27 and 28 in Special (Drug) Case
No.2 of 2018 of the learned Additional Sessions Judge-3,
Parbhani, dated 29 August 2019, is quashed and set
aside.
iii) Applications below Exhibits-27 and 28 are allowed, and
the accused stand discharged in the present crime.
iv) The bail bonds and surety bonds are cancelled.
v) The surety stands discharged.
vi) Rule made absolute in above terms.
( S. G. MEHARE )
JUDGE
rrd
