THE HONOURABLE SRI JUSTICE SAMUDRALA GOVINDARAJULU
CRIMINAL PETITION No.6019 of 2012
27-08-2012
M/s.Associated Biotech and 4 others
The State Government of A.P. rep. by Asst. Director,Incharge Drugs Inspector,
Mahabubnagar District, Rep. by its Public Prosecutor
Counsel for the Petitioners : M/s.Dilip Kumar Jaiswal
Counsel for the Respondent: Public Prosecutor
<Gist :
>Head Note:
? Cases referred:
(2008)3 Supreme Court Cases (Cri) 20
ORDER :
The petitioners 1 to 5/A-1 to A-5 are accused of offences punishable under
Sections 27(d) of the Drugs and Cosmetics Act, 1940 (in short, the Act) for
violation of Section 18(a)(i)/16 and schedule-II and punishable under Section
27(c) of the Act for violation of Section 18(a)(i)/17B(d) of the Act. A-1 is
having approval to manufacture drug viz., Rabpraz from the Licensing Authority,
Shimla and A-2 to A-5 are partners of A-1 firm. It is alleged that they are all
responsible for the day-to-day activities of the firm. On 05.09.2008 Drugs
Inspector, Mahaboobnagar District had drawn sample of Rabpraz tablets from G.M.
Medical and General Stores, Atmakur by allegedly following procedure prescribed
by law and forwarded sealed portion of the sample drug to the Government
Analyst, Drugs Control Laboratory, Hyderabad under registered parcel. On
06.07.2009, analysis report of the sample drug is received in Form-13 from the
Government Analyst declaring the sample as not of standard quality for the
reason that the sample does not comply the Assay for Rabprazole Sodium as per
STP (claim 20mg/tablet, found 4.9 mg/tablet). On 03.12.2009, the incharge drugs
inspector addressed notice to Proprietor of G.M. Medical and General Stores to
disclose source of supply of the sample drug under Section 18(A) of the Act and
to submit copy of purchase invoice. On the same day, reply was received from
the said proprietor that subject batch drug was purchased from Thirumala Pharma,
Mahabubnagar through invoice dated 14.06.2008, along with enclosure of attested
copy of purchase invoice. On the same day, the incharge drugs inspector notice
under Section 18(A) and 22(1)(cca) of the Act to Thirumala Pharma, Mahabubnagar
requesting to disclose source of the sample drug and to submit copies of
purchase invoice. The drugs inspector also handed over a sealed portion of the
sample drug and copy of analysis report to Partner of Thirumala Pharma under
Section 23(4)(ii) and 25(2) of the Act. On 04.12.2009, reply was received from
Thirumala Pharma stating that the subject batch drug was purchased from Neosun
Biotech India Pvt. Ltd, Hyderabad vide invoice dated 07.06.2008 and from Sadguru
Pharmaceuticals, Hyderabad vide invoice dated 05.03.2008. Attested copies of
purchase invoices were also furnished. On 29.12.2009, incharge drugs inspector
addressed letter to Neosun Biotech India Pvt., Ltd., Hyderabad under Sections
18(A), 18(B) and 22(1)(cca) of the Act to disclose source of supply and to
submit purchase invoices. On 07.01.2010 reply was received from Neosun Biotech
India Pvt., Ltd., stating that the subject drug was purchased from A-1 through
invoice dated 31.07.2007, along with attested copy of purchase invoice and sale
bill. On 12.01.2010, incharge drugs inspector addressed notice to Sadguru
Pharmaceuticals, Hyderabad under Sections 18(A), 18(B), 22(1)(cca) of the Act to
disclose source of supply of the sample drug. The said notice sent by
registered post was returned unserved as left. On 02.02.2010, incharge drugs
inspector, Mahabubnagar personally visited Neosun Biotech India Pvt., Ltd.,
Hyderabad and on enquiry found that 1000 strips of Rabpraz tablets were sold to
Sadguru Pharmaceuticals by them through sales invoice dated 08.11.2007. On
11.02.2010, incharge drugs inspector addressed notice to A-1 under Section 18(B)
and 22(1)(cca) of the Act to confirm the manufacture and sale of the sample drug
and to submit details of manufacturing licences manufacturing and analytical
records. On 22.04.2010, reply was received from A-1 stating that the product is
already expired and it is not available in the market and their control samples
found quality based over expiry. Hence, Assistant Director who is incharge
drugs inspector, Mahabubnagar District filed complaint in the lower Court
against A-1 to A-5 for punishing them under the above provisions for the alleged
violations. The complaint was filed before the Magistrate on 04.08.2010. The
Magistrate took cognizance and issued summonses to A-1 to A-5 by order dated
14.11.2011.
2) Form 17 of the Drugs Inspector, Mahabubnagar contains details of sample
taken in this case. The sample drug is from Batch No.AP75L73, manufactured in
July, 2007 and date of expiry in June, 2009.
3) It is contended by the petitioners' counsel that the analyst report in
this case was received by Drugs Inspector on 06.07.2009 by which month the
sample drug expired and the complaint was filed before the Magistrate thereafter
on 04.08.2010 and the offences were taken cognizance by the Magistrate on
14.11.2011 and therefore, the petitioners/accused have lost their valuable right
of sending second sample to the Central Drugs Laboratory for second analysis and
for revised report, challenging report of the Government analyst, Hyderabad.
The relevant provisions of the Act on this aspect are Sections 25(3) and 25(4)
which read as under:
"25. Reports of Government Analysts:- --------------------- --------------------
--------------------------------------------------------------
(3) Any document purporting to be a report signed by a Government Analyst under
this Chapter shall be evidence of the facts stated therein, and such evidence
shall be conclusive unless the person from whom the sample was taken or the
person whose name, address and other particulars have been disclosed under
Section 18-A has, within twenty-eight days of the receipt of a copy of the
report, notified in writing the Inspector or the Court before which any
proceedings in respect of the sample are pending that he intends to adduce
evidence in controversion of the report.
(4) Unless the sample has already been tested or analysed in the Central Drugs
Laboratory, where a person has under sub-section (3) notified his intention of
adducing evidence in controversion of a Government Analyst's report, the Court
may, of its own motion or in its discretion at the request either of the
complainant or the accused cause the sample of the drug or cosmetic produced
before the Magistrate under sub-section (4) of Section 23 to be sent for test or
analysis to the said Laboratory, which shall make the test or analysis and
report in writing signed by, or under the authority, of the Director of the
Central Drugs Laboratory the result thereof, and such report shall be conclusive
evidence of the facts stated therein.
--------------------------------------------------------------------------".
4) Under Section 25(3) of the Act, the accused has got right to receive
copy of the analysis report of the Government Analyst and within 28 days of
receipt of copy of such report, right to notify his intention in writing either
to the Inspector or to the Court before which the proceedings in respect of the
sample are pending to adduce evidence in controversion of the analysis report.
In such an event, sub-section (4) of Section 25 of the Act makes it incumbent on
the Court either suo motu or at the request of either of the parties to send
another sample of the drug to the Central Drugs Laboratory for analysis and
report. Under Sub-section (5) thereof, it is for the Court to direct either the
complainant or the accused to bear expenses for the exercise under sub-section
(4). The exercise under sub-section (4) of Section 25 of the Act could be of
use in case quality life of the sample drug did not expire by then. In the
present case, sample drug expired by June, 2009. Unfortunately, analysis report
dated 26.06.2009 was received by the complainant on 06.07.2009 after expiry date
of the sample drug. There is inordinate delay in analysing the sample by the
Government analyst and sending report of analysis. It is left unexplained. On
the same date of obtaining sample i.e., on 05.09.2008, the Drugs Inspector
dispatched one part of the sample to the Government analyst for analysis along
with necessary forms. The analysis report reads that sample was received by the
Government analyst on 08.09.2008 itself. In spite of it, analysis of the sample
drug could not be made and analyst report could not be prepared till 26.06.2009.
All the events subsequent to the date of receipt of analysis report become
futile, as by the respective dates, quality life of the sample drug had expired.
5) Drugs Inspector could have taken steps under Section 18(A) of the Act
immediately after obtaining the sample and sending the same for analysis and
without waiting for receipt of the analysis report. Similarly, Drugs Inspector
could have taken steps under Section 18(B) and 22(1)(cca) of the Act even before
receipt of the analysis of report, as the Drugs Inspector obtained samples
suspecting the drug to be of not standard quality and has reason to believe the
same. Instead, Drugs Inspector took prolonged steps even after receipt of
analysis report stage by stage. When there is label declaration giving
manufacturer's name as A-1 together with its address, there was no reason for
the Drugs Inspector to wait till the end to address A-1 for information under
Sections 18(B) and 22(1)(cca) of the Act. Thus, unnecessary delays could have
been avoided by Drugs Inspector in case he acted swiftly after obtaining
suspected drug sample and sending the same to the Government Analyst for
analysing and even before receipt of analysis report. In any event, Drugs
Inspector cannot be responsible for the delay in this case as analysis report
was received by him from the Government analyst on 06.07.2009 after expiry date
of the sample drug.
6) In Medicamen Biotech Limited V. Rubina Bose1 of the Supreme Court it
was held that the delay deprived valuable right under Sections 25(3) and 25(4)
of the Act and it should necessitate quashing of the proceedings against the
accused.
7) It is contended by the Additional Public Prosecutor that in order to
send second sample to Central Drugs Laboratory for second analysis, the accused
could have notified his intention in writing under Section 25(3) to adduce his
evidence in controversion of the report of the Government analyst. Such
expression of intention by notification in writing arises only in case the
proceedings are started even before expiry date of the sample drug. In this
case, the question of exercising option or notifying intention under Section
25(3) of the Act does not arise, as report of the Government analyst was
received after expiry date of the sample drug. In such a case, the accused has
no opportunity to notify his intention under Section 25(3) of the Act as even if
such intention is notified, there is no subsistence of shelf life of the sample
drug as the sample drug had already expired. In these circumstances, the
accused suffered great prejudice as the accused is deprived of valuable right of
defence of having opportunity to get correctness of analysis report of the
Government analyst challenged. Hence, continuation of proceedings in the lower
Court for further trial becomes futile exercise.
8) Accordingly, the Criminal Petition is allowed quashing proceedings in
C.C. No.102 of 2011 on the file of Judicial Magistrate of the First Class,
Atmakur, Mahabubnagar District.
_______________________________
SAMUDRALA GOVINDARAJULU, J
August 27, 2012
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