Jackson Laboratories Private Limited ... vs The State Of Jharkhand on 20 July, 2022

[Cites 21, Cited by 0]

Jharkhand High Court

Jackson Laboratories Private Limited ... vs The State Of Jharkhand on 20 July, 2022

1.Jackson Laboratories Private Limited at 22-24, Majitha Road, Bye-Pass, Amritsar, PO-Amritsar, PO-Amritsar, PS-Amritsar, District Amritsar (Punjab), represented through its Authority Signatory-Jugal Kishore, aged about 72 years, son of late Sh.Chaman Lal, resident of 13, Joshi Colony, PO Amritsar, PS Civil Lines, District Amritsar, State Punjab

2.Jugal Kishore, aged about 72 years, son of late Sh.Chaman Lal, resident of 13, Joshi Colony, PO Amritsar, PS Civil Lines, District Amritsar, State Punjab

3.Ramesh Kumar, aged about 67 years, son of late Sh.Chaman Lal, resident of 183, Hargobind Enclave, PO Preet Vihar, PS Anand Vihar, District Delhi-State New Delhi

4.Sudhir Kumar, aged about 56 years, son of late Sh.Chaman Lal, resident of 13, Joshi Colony, PO Amritsar, PS Civil Line, District Amritsar, State of Punjab ..... Petitioners

-- Versus --

1.The State of Jharkhand

2.Poonam Tirkey, , d/o not known, Drug Inspector, Ranchi-III, District Food and Drug Control Building, Sadar Hospital Campus, PO GPO, Ranchi, PS Kotwali, District Ranchi ...... Opposite Parties

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CORAM: HON'BLE MR. JUSTICE SANJAY KUMAR DWIVEDI

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For the Petitioners :- Mr. Bibhash Sinha, Advocate For the State :- Mr. P.D.Agarwal, Spl.P.P.

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10/20.07.2022 Heard Mr. Bibhash Sinha, the learned counsel appearing for the petitioners and Mr. P.D.Agarwal, the learned counsel appearing for the respondent State.

This petition has been filed for quashing of the entire criminal proceeding including the order dated 08.12.2020 passed by learned A.J.C.-II, Ranchi, in Drugs and Cosmetic Case No.10 of 2020, whereby the court has taken cognizance of section 27(d) and 28-A of Drugs and Cosmetics Act, 1940, the matter is pending in the court of learned A.J.C.-II, Ranchi.

The complaint was filed by the Drugs Inspector alleging therein that the Drug Inspector has filed complaint before the 2 Cr.M.P. No. 1382 of 2021 learned Chief Judicial Magistrate, Ranchi alleging therein that the Drug Inspector has collected one drug in the name and style of 'Atenolol Tablet' on 17.02.2020 from M/s State Dispensary, Doranda, Ranchi, manufactured and sold by M/s Jackson Laboratories Pvt. Ltd. and he got it tested from State Drug Testing Laboratory, Jharkhand, a competent authority for the said testing and found the said seized drug not of standard quality vide Report No.SDTL/JH/GA-58/2020 dated 13.3.2020 (Form 13) (Annexure-IV) and it is violation of view of drugs and Cosmetics Act and Rules. Further the allegation against the accused is that they failed to provide the required information and failed to maintain required registers, documents etc. violating section 18B of Drugs and Cosmetics Act punishable under section 28-A of Drugs and Cosmetics Act.

Perused the prosecution report along with the documents. On perusal of prosecution report, it appears that the prosecution report filed mentioning therein that on 17.02.2020, the complainant cum Drug Inspector has collected one drug in the name and style of Atenolol Tablet from M/s State Dispensary, Doranda, Ranchi, manufactured and sold by M/s Jackson Laboratories Pvt. Ltd. and the same was reported not of standard quality by State Drug Testing Laboratory, Ranchi, and thus the Drug Inspector filed this case against the accused namely, 1.Jugal Kishore the Managing Director,

2.Sudhir Kumar the Director, 3.Ramesh Kumar and another Director of M/s Jackson Laboratories Pvt. Ltd. and 4.M/s Jackson Laboratories Pvt. Ltd.

The Drug Inspector cum complainant of this case has collected one tablet of drug namely Atenolol Tablet on 17.2.2020 from M/s State Dispensary, Doranda, Ranchi, manufactured and sold by M/s Jackson Laboratories Pvt. Ltd. and he got it tested from Drug Testing Laboratory, Jharkhand, a competent authority for the said testing and found the said seized drug substandard and the company and the accused further failed to provide the required information and produced documents and registers to be maintained by them under section 18B of Drugs and Cosmetics Act when called for by the concerned Drug Inspector. The letter etc. communicated to the company has been filed with this prosecution report and thus it 3 Cr.M.P. No. 1382 of 2021 is violation of section 18(a)(i), 18(a)(vi), 18(c), 18(B) Drugs and Cosmetics Act and Rules and punishable under section 27(d) and 28-A of Drugs and Cosmetics Act, 1940.

Mr. Bibhash Sinha, the learned counsel for the petitioners submits that drug in question was seized on 17.02.2020 and the report was received by the prosecution on 13.03.2020. He submits that said sample was sent on 04.07.2020, received on 13.07.2020 and on 31.07.2020 the petitioners filed the reply before the concerned Drug Inspector alongwith test report in light of section 25(3) of the Act. The prosecution was filed on 27.10.2020. The petition was filed by the petitioners on 17.01.2020 under section 25(4) of the Act and cognizance was taken on 08.12.2020. He submits that the statutory provisions of sub sections 3 and 4 of section 25 of the Drugs and Cosmetics Act, 1940 [hereinafter referred to as the Act] has not been followed and in light of that the right of the petitioner has been infringed and this aspect of the matter is covered by the judgment of Hon'ble Supreme Court in the case of Medicamen Biotech Limited and Another v. Rubina Bose, Drug Inspector, (2008)7 SCC 196. Paragraph nos.13, 16 and 18 of the said judgment are quoted below:

"13. As would be evident, the matter would turn on an examination of the legal provisions. Section 23 of the Act provides the procedure for taking of samples and sub- section (4) thereof, as already mentioned above, provides that the sample shall be divided into four portions and be kept/disposed of in the manner laid therein including one sample to be produced before the Magistrate. Section 25 is reproduced below:

"25. Reports of Government Analysts.--(1) The Government Analyst to whom a sample of any drug or cosmetic has been submitted for test or analysis under sub-section (4) of Section 23, shall deliver to the Inspector submitting it a signed report in triplicate in the prescribed form.

(2) The Inspector on receipt thereof shall deliver one copy of the report to the person from whom the sample was taken and another copy to the person, if any, whose name, address and other particulars have been disclosed 4 Cr.M.P. No. 1382 of 2021 under Section 18-A, and shall retain the third copy for use in any prosecution in respect of the sample. (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.

(5) The cost of a test or analysis made by the Central Drugs Laboratory under sub-section (4) shall be paid by the complainant or accused as the court shall direct.

A reading of the aforesaid provisions would reveal that they lay certain obligations as well as provide safeguards for a person from whom a drug has been seized for analysis or testing as Section 25(3) specifies that unless such a person controverts the correctness of the report submitted by the Government Analyst within 28 days in writing that he intends to adduce evidence to controvert the report of the analyst, it would be deemed to be conclusive evidence of the quality of the drug whereas sub-section (4) of Section 25 obliges the Magistrate on the request of the complainant or the accused or on his own motion to send the fourth sample which has been disputed for fresh testing to the Director of the Central Drugs Laboratory.

16. It is, therefore, evident that the appellant had not once but on at least two occasions and within 28 days of the receipt of the show-cause notice clarified that it intended to adduce evidence to show that the test report of the Government Analyst was not correct. The 5 Cr.M.P. No. 1382 of 2021 judgments cited by the learned counsel for the respondent, therefore, do not apply to the facts of the case as they were given in the context where the dealer/manufacturer had not expressed its desire to challenge the veracity of the report of the Drugs Analyst.

18. In Unique Farmaid case [(1999) 8 SCC 190 : 1999 SCC (Cri) 1404] 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 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 6 Cr.M.P. No. 1382 of 2021 Magistrate had not been sent for reanalysis. The observations in Amery Pharmaceuticals case [(2001) 4 SCC 382 : 2001 SCC (Cri) 724] 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 2-7-2002 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 2-7-2002 it would have been well-nigh impossible to get the sample tested before its expiry."

He further submits that once the right has been applied by the petitioner under the Act to file and intent to lead evidence before the Court even assuming that there was no prayer in terms of sub section 3 of section 25 of the Act in light of the further petition under section 25(4) the court was also having power to send the sample for analysis which has not been done. He has also relied in the case of Laborate Pharmaceuticals India Limited and Others v. State of Tamil Nadu, (2018) 15 SCC 93. Paragraph no.8 of the said judgment is quoted below:

"8. All the aforesaid facts would go to show that the valuable right of the appellant to have the sample analysed in the Central Laboratory has been denied by a series of defaults committed by the prosecution; firstly, in not sending to the appellant manufacturer part of the sample as required under Section 23(4)(iii) of the Act; and secondly, on the part of the Court in taking cognizance of the complaint on 4-3-2015 though the same was filed on 28-11-2012. The delay on both counts is not attributable to the appellants and, therefore, the consequences thereof cannot work adversely to the interest of the appellants. As the valuable right of the accused for reanalysis vested under the Act appears to have been violated and having regard to the possible shelf life of the drug we are of the view that as on date the prosecution, if allowed to continue, would be a lame prosecution."

On these grounds, he submits that the entire criminal proceeding is fit to be quashed.

Per contra, Mr. Agarwal, the learned counsel appearing on 7 Cr.M.P. No. 1382 of 2021 behalf of the respondent State submits that the petition filed by the petitioners before the Drug Inspector was not an intention since sub section 3 of section 25 of the Act has not been invoked by the petitioners, and he is not entitled for relief for subsequent petition filed under sub section 4 of section 25 of the Act. To buttress his argument, he relied in the case of Glaxo Smit Kline Pharmaceuticals Ltd. and Another v. State of Madhya Pradesh, AIR 2011 SC 2998.

Paragraph nos. 7 and 11 of the said judgment are quoted below:

7. The issue involved herein is no more res integra. The issue has been examined time and again. It is a settled legal proposition that the report of the analyst is conclusive. It means that no reasons are needed in support of conclusion given in the report, nor is it required that the report should contain the mode or particulars of the analysis. (See Dhian Singh v. Municipal Board, Saharanpur [(1969) 2 SCC 371 : AIR 1970 SC 318] .) However, the law permits the drug manufacturer to controvert the report expressing his intention to adduce evidence to controvert the report within the prescribed limitation of 28 days as provided under Section 25(3) of the 1940 Act. In the instant case, the report dated 27-8-1997 was received by the statutory authorities who sent the show-cause notice to the appellants on 29-9-1997 and the appellants replied to that notice on 3-11-1997. The case of the statutory authorities is that option/willingness to adduce evidence to controvert the analyst's report was not filed within the period of 28 days i.e. limitation prescribed for it. The appellants are the persons who knew the date on which the show-cause notice was received. For the reasons best known to them, they have not disclosed the said date. It is a Company which must be having Receipt and Issue Department and should have an office which may inform on what date it has received the notice, and thus, should have made the willingness to controvert the report.

In fact, such application had only been made on the technique adopted for analysis. It has been the case that instead of testing the medicine under IP 1985, it could have been done under IP 1996 because IP 1996 had come into force prior to the date of taking the sample on 9-12-1996.

11. It is pertinent to mention herein that the present appellants had earlier also been informed by the Drug Inspectors of various cities on many occasions that the aforesaid medicine i.e. Betnesol tablet, was not of standard quality and the authorities had been making an attempt to initiate proceedings against them as is evident from the pleadings taken 8 Cr.M.P. No. 1382 of 2021 by the appellants themselves and the letter dated 1-7-1996 (Annexure P-9) wherein the appellant Company wrote a letter to the Controller, Food and Drug Administration, Madhya Pradesh. The relevant part thereof reads as under:

"During the past one month we have received requests from the Drug Inspectors of Dhar, Rewa, Seoni and Ambikapur all under your kind control, to provide memorandum of articles of association, constitution, etc. of our Company to initiate action for manufacturing Betnesol tablets Batch No. NA 660, Mfd. December 1992, Expiry May 1994; NB 290, Mfd. November 1994, Expiry April 1996; NB 538, Mfd. May 1995, Expiry December 1996 and NB 656, Mfd. September 1995, Expiry February 1997, which were earlier declared as not of standard quality by the Government Analyst, Bhopal for facing analytical difficulties during the determination of uniformity of content by IP 1985 method."

(emphasis added) In that letter also the appellant Company does not make its intention clear to adduce any evidence to controvert the government analyst's report, rather made the following request:

"Under these circumstances, we respectfully reiterate that our product Betnesol tablets referred above are of standard quality and request you to kindly treat all the matters as closed."

Relying on this judgment Mr. Agarwal, the learned counsel for the respondent State submits that since the petitioners have not intended to adduce the evidence the judgment relied by the petitioners is not helping to them and this case is fit to be dismissed.

In light of the above submissions of the learned counsels appearing for the parties the Court has gone through the materials on record and finds that drug in question was seized on 17.02.2020 and the report was received by the prosecution on 13.03.2020. The said sample was sent on 04.07.2020, received on 13.07.2020 and on 31.07.2020 the petitioners filed the reply before the concerned Drug Inspector alongwith test report in light of section 25(3) of the Act. The prosecution was filed on 27.10.2020. The petition was filed by the petitioners on 17.01.2020 under section 25(4) of the Act and cognizance was taken on 08.12.2020.

Sub sections 3 and 4 of section 25 of the said Act is quoted below:

9 Cr.M.P. No. 1382 of 2021

"(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 5 [or the person whose name, address and other particulars have been disclosed under section 18A] 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 1 [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."

Looking to the petition filed by the petitioners before the Drug Inspector it transpires that the petitioners along with that letter has also annexed samples etc. by the petitioners of private laboratory in support of his contention, thus it is apparent that the petitioners were intended to adduce the evidence in light of sub section 3 of section 25 of the said Act. It is an admitted position that the petitioners filed further petition before the learned court under sub section 4 of section 25 of the Act disclosing therein that the applicant sent the reply dated 31.07.2020 pointing out various anomalies in testing of the impugned drug. Since the drug was tested in the quality control laboratory by the applicant and the same was found to be 100.3 %. In that petition it has been also disclosed that the petitioner has prepared a demand draft for re-testing of the drug in question and in spite of the petition filed by the petitioner under sub section 4 of section 25 of the Act the learned court has not 10 Cr.M.P. No. 1382 of 2021 sent it to the Central Drug Laboratory and sub section 4 of section 25 of the Act speaks the court may of its own motion or in its discretion add the request of either complainant or accused may cause sample of drug.

Seeing this, it appears that it was once the petition was filed along with bank draft it was incumbent upon the court to send the same for test.

Thus, in the case in hand it is apparent that the petitioners were intended to adduce additional evidence in light of the petition filed before the Drug Inspector along with test reports. The subsequent petition filed under sub section 4 of section 25 of the Act is also supports the case of the petitioners. In the case relied by Mr. Agarwal, the learned counsel appearing for the respondent State in case of Glaxo Smit Kline Pharmaceuticals Ltd. and Another v. State of Madhya Pradesh(supra), the facts of filing of petition under sub section 4 of section 25 was not there and the contrary test report was also not annexed with the petition filed before the court or the Drug Inspector.

Thus, that judgment is not helping the respondent State. The case is covered in the light of the judgment relied by the petitioners in the case of "Medicamen Biotech Limited and Another v. Rubina Bose, Drug Inspector" and Laborate Pharmaceuticals India Limited and Others v. State of Tamil Nadu" (supra).

Accordingly, the entire criminal proceeding including the order dated 08.12.2020 passed by learned A.J.C.-II, Ranchi, in Drugs and Cosmetic Case No.10 of 2020, pending in the court of learned A.J.C.-II, Ranchi is quashed.

Cr.M.P. No. 1382 of 2021 stands disposed of.

I.A. if any also stands disposed of.

( Sanjay Kumar Dwivedi, J.) SI/

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