Jharkhand High Court

M/S Karnataka Antibiotics & ... vs The State Of Jharkhand on 7 December, 2021

                                                1

                   IN THE HIGH COURT OF JHARKHAND AT RANCHI
                             Cr.M.P. No. 1068 of 2013
             1.   M/s KARNATAKA ANTIBIOTICS & PHARMACEUTICALS LTD., having its
                  registered office at Dr. Rajkumar Road, Block, Rajajinagar, Bagalore
                  through Mandayam Narasiwodiyar Vijay Kumar, son of late M.N.
                  Narayana Lyengar, General Manager (Marketing) resident of Dr.
                  Rajkumar Road, 1 Block, Rajajinagar, Banagalore, P.O. & P.S.
                  Rajajinagar, District Bangalore (Karnataka)
             2.   Kanahialal Lavajidhai Jala, son of L.G. Jala, at present posted as
                  Senior Manager, Quality Assurance, Karnataka Antibiotic &
                  Pharmaceutical Ltd., resident of Flat No.29, "Mathry Chhaya", 4 th
                  Block, Doddabommasandra Near R. R. High School, Vidyaranyapura,
                  P.O. & P.S. Vidyaranyapura, District Bangalore- 560097
                                                                    ... Petitioners
                                          -Versus-
             1.   The State of Jharkhand
             2.   Surendra Prasad, son of not known, Drug Inspector, Dhanbad in the
                  office of Civil Surgeon-cum-Chief Medical Officer, Dhanbad, P.O., P.S. &
                  District- Dhanbad                                 ... Opposite Parties
                                            -----

             CORAM:      HON'BLE MR. JUSTICE SANJAY KUMAR DWIVEDI
                                            -----
             For the Petitioners            : Mr. Deepak Kumar Prasad, Advocate

For the Opposite Party-State : Mr. Suraj Verma, Spl. P.P.

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05/07.12.2021. Heard Mr. Deepak Kumar Prasad, learned counsel for the petitioners

and Mr. Suraj Verma, learned Spl. P.P. for the opposite party-State.

2. This application has been filed for the following reliefs:

"For quashing of entire criminal proceeding in connection with

C.O. Case No. 89/2011 dated 09.08.2011 under Sections 18(a)

(i)(vi), 18(b) and 27(d) of the Drug and Cosmetic Act, 1940,

including the order taking cognizance dated 09.08.2011 passed

by learned Chief Judicial Magistrate, Dhanbad."

3. Counsel for the petitioners submits that the present case is fully

covered by the judgment passed by the Hon'ble Supreme Court in

"Medicamen Biotech Limited & Another Vs. Rubina Bose, Drug

Inspector" reported in (2008) 7 SCC 196 and followed by this Court in

Cr. M.P. No. 152/2012 and Cr. M.P. No. 94/2012, all decided in the case filed

by the present petitioners only.

4. He further submits that the complaint was made by the opposite

party no.2 dated 09.08.2011 in which it is alleged that the medicine Verclav

625 (Amoxycillin & Potassium Clavulanate Tablets, IP) Batch No.

KAVL09002, D.M. 07/2009, D.E. 06/2011 was supplied by the manufacturer

M/s Ankur Drug and Pharma Limited, Nalagarh, District Solan under lease

licence of the petitioner's firm was found substandard and accordingly the

complaint was lodged on 09.08.2011.

5. The learned counsel for the petitioners submits that on 15.12.2009,

the sample was taken from the jail, Dhanbad while taking the sample of

medicine the Drug Inspector has also not followed the statutory provision

under Section 23(4)(i)(iii) of the Drug and Cosmetic Act, 1940. He further

submits that as per the report of the Government Analyst, the sample of

medicine was not of standard quality. The certificate is annexed at

Annexure-2 of the petition. He also submits that the report of the

Government Analyst was challenged by the Company. He further submits

that the complaint was lodged before the learned Chief Judicial Magistrate,

Dhanbad after expiry of medicine and therefore, the valuable right has not

availed under Section 25(4) by the petitioners. He submits that in such

circumstances, the entire criminal proceedings including order taking

cognizance is fit to be quashed as the mandatory provisions of Drugs and

Cosmetics Act, 1940 has not been followed and great prejudice has been

caused to the petitioners. Counsel for the petitioners has relied upon

judgment passed by the Hon'ble Supreme Court reported in " Medicamen

Biotech Limited" (supra) as well as orders passed by this Court in Cr.

M.P. No. 152 of 2012 and Cr. M.P. No. 94 of 2012 and submits that under

similar circumstances, the entire criminal proceeding has been quashed by

the High Court as well as by the Hon'ble Supreme Court.

6. Counsel for the State while opposing the prayer submits that as per

the report of the Central Drug Laboratory, Kolkata vide report no.30-

2/2010-SS/JR-8/917 dated 23.08.2010, the sample does not conform to IP

with respect to assay, uniformity to content and dissolution tests of

Clavulinic Acid.

7. After hearing the counsel for the parties and after considering the

facts and circumstances of this case, this Court finds that the criminal case

was initiated in connection with the drug, namely, Verclav 625 (Amoxycillin

& Potassium Clavulanate Tablets, IP) Batch No. KAVL09002, D.M. 07/2009,

D.E. 06/2011, and it is the specific case of the petitioners that the

complaint was lodged after expiry of medicine and therefore the valuable

right has not availed under Section 25(4) by the petitioners. In the

aforesaid facts and circumstances, there appears to be noncompliance of

the statutory provision of the Drugs and Cosmetic Act, 1940 so far as the

petitioners are concerned. Such violation of the mandatory provisions of

the said Act vitiates the entire criminal proceedings against the petitioners

as it has caused great prejudice to the petitioners which cannot be cured at

this point of time, as admittedly the shelf life of the drug has already

expired.

8. This case is fully covered by the judgment passed by the Hon'ble

supreme court reported in the case of " Medicamen Biotech Limited &

Another Vs. Rubina Bose, Drug Inspector" reported in (2008) 7 SCC

196, at Para 18 and 19 it has been held as under:

"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:

"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 controvert 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.

13. 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 appeals." 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 f or 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 in as much as 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 2.07.2002 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 the expiry."

19. In the affidavit filed to the petition by Dr. D. Rao, Deputy Drugs Controller, and in arguments before us, it has been repeatedly stressed that the delay in sending of the sample to the Central Drugs Laboratory had occurred as the appellant had avoided services of summons on it till 09.05.2005. This isbegging the question. We find that there is no explanation as to why the complaint itself had been filed about a month before the expiry of the shelf life of the drug and concededly the filing of the complaint

had nothing to do with the appearance of the accused in response to the notices which were to be issued by the Court after the complaint had been filed. Likewise, we observe that the requests for retesting of the drug had been made by the appellant in August/September, 2001 as would be clear from the facts given above and there is absolutely no reason as to why the complaint could not have been filed earlier and the fourth sample sent for retesting well within time. We are, therefore, of the opinion that the facts of the case suggest that the appellant have been deprived of a valuable right under Sections 25(3) and 25(4) of the Act which must necessitate the quashing of the proceedings against them."

9. The aforesaid judgement has been followed by this Court in Cr. M.P.

No. 94 of 2012 (M/s. Laborate Pharmaceuticals India Ltd. and another vs.

State of Jharkhand and another) and also in Cr. M.P. No. 152 of 2012 (M/s

Laborate Pharmaceuticals India Ltd. and another vs. State of Jharkhand

and another), wherein the criminal cases have been quashed on similar

grounds.

10. As a cumulative effect of the aforesaid findings and in view of the

aforesaid judicial pronouncements, the entire criminal proceeding in

connection with C.O. Case No. 89/2011 dated 09.08.2011 including the

order taking cognizance dated 09.08.2011 passed by learned Chief Judicial

Magistrate, Dhanbad so far it relates to the petitioners is hereby quashed.

11. This application is accordingly allowed and disposed of. Pending I.A.,