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Judgment
The present petitioners have challenged initiation of a criminal case against them by the present respondent in the Court of City Civil and Sessions
Judge at Bengaluru for the alleged violation of Sections 18(a)(i) and Section 17B(d) which are punishable under Sections 27(c) and 27(d) of the Drugs
and Cosmetics Act, 1940.
The summary of the case as could be gathered at this stage are; that the first petitioner (Accused No.1) Company is the manufacturer of a drugs
for human consumption with the commercial name Zoxil CV Dry Syrup (Amoxyllin and Potassium Clavulanate for Oral Suspension IP). The
Inspector attached to the respondent Department visited one of the drug shop by name M/s Shree Maruthi Chemist, Bengaluru-75 on 13.09.2011 and
took the sample of said Zoxil CV suspension and sent it for its testing to the Government Analyst, Drugs Testing Laboratory, Bengaluru, Karnataka.
The Government Analyst tested the said drug, the report of which was received by the respondent on 16.01.2012. The test report and analysis in Form
No.13 issued by the Government Analyst, Drugs Testing Laboratory, Bengaluru declared that the said drug was “not of standard quality†with
respect to “Assay†for Amoxyllin and Clavulanate acid.
After receipt of a copy of the said test report, the petitioners sent a reply dated 04.02.2012 along with certificate of analysis and results and stated
that they do not accept the report of the Government Analyst for which they wanted the seized sample to be sent to Central Drug Testing Laboratory
(henceforth for brevity referred to as ‘CDTL’) at Kolkatta for counter checking the result. As such, the Drug Inspector, Circle â€" V,
Bengaluru filed a petition under Section 25(4) of Drugs and Cosmetics Act, 1940, in the Court of the Special Court (Economic Offences), Bengaluru,
requesting the Court to send the seized portion of Zoxil CV suspension to CDTL, Kolkatta for test and analysis. The said Court, by its order dated
17.02.2012 ordered for sending the sample in proper intact condition to CDTL at Kolkatta. Accordingly, the drug was sent to CDTL, Kolkatta, which
laboratory by its report dated 12.03.2012 at Annexure-G, which report was accompanied along with Form No.2, certificate of test or Analysis by the
Central Drugs Laboratory, stated that it tested the said drug on 27.02.2012 and found that the sample was of sub-standard. Thereafter, the respondent
Department obtaining sanction from the Drug Controller from the State of Karnataka for investigation and for further proceeding and obtaining
permission to launch prosecution against the petitioners has instituted a criminal case by lodging a complaint under Section 200 of Criminal Procedure
Code, 1973 in the Court of Principal City Civil and Sessions Judge at Bengaluru in PCR No.29/2015. After taking cognizance, the CC No.243/2015
was given. It is the said CC No.243/2015 which the petitioners are seeking for quashing in this petition.
The argument of the learned counsel for the petitioner is on two fold. The first leg of his argument is that the CDTL has tested the sample sent to it
on the last day of the expiry of the drug, as such the test report cannot be accurate.
On this point learned High Court Government Pleader appearing for the respondent submitted that even though the test is said to have been
conducted on the last date of expiry, same falls within the shelf life of the sample drug, as such, the test report cannot be called inaccurate.
Learned counsel for the petitioner in his support relied upon the judgment of the Hon’ble Apex Court in the case of Medicamen Biotech Limited
and another Vs. Rubina Bose, Drug Inspector reported in (2008) 7 SCC 196 and while drawing the attention to Paragraph 18 of the said judgment, he
submitted that in the instant case also the drug since was tested by CDTL, just two days prior to its expiry, the test report cannot be accepted.
The Paragraph 18 of the Medicamen’s case supra is reproduced here below:
“18. In Unique Farmaid case which was a case under the Insecticides Act which has provisions analogous to Section 25(4) of the Act, the Court
found that the accused had indeed made a request to the Inspector for sending the sample for retesting within the prescribed time-limit and as this
request had not been accepted an important right given to an accused had been rendered ineffective on which the proceedings could be quashed. This
is what the Court had to say:(SCC p.197, paras 12-13)
“12. It cannot be gainsaid, therefore, that the respondents in these appeals have been deprived of their valuable right to have the sample tested
from the Central Insecticides Laboratory under sub-section (4) of Section 24 of the Act. Under sub-section (3) of Section 24 report signed by the
Insecticide Analyst shall be evidence of the facts stated therein and shall be conclusive evidence against the accused only if the accused do not, within
28 days of the receipt of the report, notify in writing to the Insecticides Inspector or the court before which proceedings are pending that they intend to
adduce evidence to controvert the report. In the present cases the Insecticides Inspector was notified that the accused intended to adduce evidence to
controvent the report. By the time the matter reached the court, the shelf life of the sample had already expired and no purpose would have been
served informing the court of such an intention. The report of the Insecticide Analyst was, therefore, not conclusive. A valuable right had been
conferred on the accused to have the sample tested from the Central Insecticides Laboratory and in the circumstances of the case the accused have
been deprived of that right, thus, prejudicing them in their defence.
In these circumstances, the High Court was right in concluding that it will be an abuse of process of court if the prosecution is continued against
the respondents, the accused persons. The High Court rightly quashed the criminal complaint. We uphold the order of the High Court and would
dismiss the appealsâ€.
We find that this judgment helps the case of the appellant rather than that of the respondent because in spite of two communications from the
appellant that it intended to adduce evidence to controvert the facts given in the report of the Government Analyst, the fourth sample with the
Magistrate had not been sent for reanalysis. The observations in Amery Pharmaceuticals case 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 02.07.2002 which is about a month short of the expiry date of the drug and as
such had the appellant-accused appeared before the Magistrate even on 02.07.2002 it would have been well-nigh impossible to get the sample tested
before its expiry.â€
A reading of the above paragraph go to show that referring to earlier case ie., State of Haryana Vs. Unique Farmaid Private Limited reported in
(1999) 8 SCC 190, the Hon’ble Apex Court has observed that once the shelf life is expired, there is no point in getting the sample tested from
Central Insecticides Laboratory.
In the instant case, according to the petitioners / accused, the expiry date of the alleged sample was ‘February, 2012’, as such, the last date
of expiration was 29.02.2012 (2012 was a leap year). Therefore, when the drug was subjected to test by CDTL on 27.02.2012 it was two days prior
to the date of expiry. Any drug for human consumption approaching the date of expiry is required to be in consumable condition and worth for
consumption in all respects till the completion of its expiry period. As such, a drug nearing expiry date, for the purpose of its testing also, cannot be
considered that the drug may not answer the tests as it could have had, the same being tested at the earlier date. Therefore, merely because the drug
under question was tested by CDTL just two days prior to expiry of its shelf life by that itself, it cannot be considered that the report given by the
CDTL cannot be an accurate report, as such, the argument of learned counsel for the petitioner on this point is not acceptable.
The second leg of argument of the learned counsel for the petitioner that the manufacturer of the said drugs Zoxil CV being the first petitioner /
accused No.1 company, no reasons are shown for arraying the present petitioner Nos.2, 3 and 4 (accused Nos.2, 3, and 4 respectively) as the
accused in the Court below. Nothing is mentioned as to how they are related to the manufacturing of the sample drug in question.
Learned High Court Government Pleader in his argument relying upon the judgment of the Hon’ble Apex Court in the case of Dinesh B. Patel
and others Vs. State of Gujarat and another reported in
(2010) 11 SCC 125 submitted that the matter involves an offence which has a direct impact on the public health, as such, as observed by the
Hon’ble Apex Court, impleading of Directors cannot be interfered with and it will be open for the petitioners / accused to show in the Trial Court
that they had nothing to do with the manufacturing process.
In the instant case, the respondent / complainant in its complaint filed in the Court below at Paragraph 38 has stated as below:
“38. That the investigation carried out and on perusal of available records and documents on file it is established that:-
A-1 M/s Vapi care Pharma Pvt. Ltd. Unit No.II, Village Belikhol, Nalagarh road, district Solon, Himachal Pradesh â€" 174101, has committed an
offence Under Section 18(a)(i) and 18(a)(i) read with 17B(d) of Drugs and Cosmetics Act, 1940 and Rules there under by manufacturing “Not of
Standard Quality†and Spurious Drugs ZOXIL CV DRY SYRUP (Amoxycillin and Potassium Clavulanate for oral Suspension) B.No.VB00914,
D/M 09/2010, D/E 02/2012 mfd. By M/s Vapi care Pharma Pvt. Ltd. Unit No.II, Village Belikhol, Nalagarh road, district Solon, Himachal Pradesh
â€" 174101 which is punishable under Section 27(c) and 27(d) of the said Act,
A-2 Sri. Kamal J Shah, Managing Director of A1 M/s. Vapi care Pharma Pvt. Ltd. Unit No.II, Village Belikhol, Nalagarh Road, District Solon
Himachal Pradesh â€" 174101 and was responsible for day to day affairs of the accused company there by committed an offence under Section 18(a)
(i) and 17B(d) of Drugs and Cosmetics Act, 1940 and Rules there under which is punishable under Section 27(c) and 27(d) of the said act,
A-3 Sri. Sudhir Kumar Singh, is a approved manufacturing chemist and production Technical person of A1 M/s. Vapi care Pharma Pvt. Ltd., Unit
No.II, Village Belikhol, Nalagarh road, district Solon Pin 174101 was responsible for manufacture of “Not of Standard Quality†and Spurious
Drug ZOXIL CV DRY SYRUP B.No.VB00914, D/M 09/2010, D/E 02/2012 there by committed an offence Under Section 18(a)(i) and 17B(d) of
Drugs and Cosmetics Act, 1940 and Rules there under which is punishable under Section 27(c) and 27(d) of the said Act.
A-4 Sri Shashikanth Surwase approved analytical Chemist of A1 M/s Vapi care Pharma Pvt. Ltd., Unit No.II, Village Belikhol, Nalagarh road,
district Solon Himachal Pradesh â€" 174101 was responsible for Analysis and after Analysis the same has been declared as “Not of Standard
Quality†and Spurious Drug ZOXIL CV DRY SYRUP B.No.VB00914, D/M 09/2010, D/E 02/2012 there by committed an offence under Section
18(a)(i) and 17B(d) of Drugs and Cosmetics Act, 1940 and Rules there under which is punishable under Section 27(c) and 27(d) of the said Act.â€
Accused No.1 being a registered company which is a manufacturing company incorporated under the Companies Act, 1956 is admittedly the
manufacturer of the alleged spurious drug Zoxil CV dry syrup in question, as such, it has been arrayed as accused No.1. Accused No.2 â€
Mr.Kamal J Shah being the Managing Director of the Company is shown to be responsible for the day-to-day affairs of the accused company, as
such, he has also been arrayed. Accused No.3 â€" Sri.Sudhir Kumar Singh is shown to be approved Manufacturing Chemist and Production Technical
person of accused No.1 company who is alleged to be responsible for manufacturing of the drug in question. Similarly, accused No.4 â€" Shashikanth
Surwase is shown to be an approved Analytical Chemist of accused No.1 â€" company and it is stated in the complaint that he is responsible for the
analysis. As such, accused Nos.2, 3 and 4 in their capacity as Managing Director, Manufacturing Chemist and Analytical Chemist respectively have
been arrayed.
Thus, apart from considering the fact that the alleged spurious drug was for human consumption, it can be seen that all the Directors of the
Company as in Dinesh B. Patel’s case supra are not impleaded, but, in the present case, it is the only the Managing Director, Manufacturing
Chemist and Analytical Chemist alone have been arrayed, as such, the second leg of argument of the learned counsel for the petitioner that accused
Nos.2, 3 and 4 have been arrayed without any basis is also not acceptable.
However, it is made clear that in case, it is the contention of accused Nos.3 and 4 that they were not in any manner involved in the manufacturing
and standard of the drug in question, it will be open for them to agitate the same in the Court below.
Barring the above, I do not find any other grounds to consider. On the other hand, the grounds agitated and analysed as above provide no reason to
allow this writ petition. Accordingly, the petition is dismissed.
At the request of learned counsel for the petitioners, considering the fact that the complaint is of some older in its age and requires an early disposal, it
is appreciated if the Court below disposes of the matter in accordance with law at the earliest.