JAYA SINGH And ANR v. STATE OF JHARKHAND

1 Cr.M.P. No. 741 of 2011 with

Cr.M.P. No. 1969 of 2011

IN THE HIGH COURT OF JHARKHAND AT RANCHI

Cr.M.P. No. 741 of 2011

1. Jaya Singh

2. Ramesh Kumar Singh … Petitioners -Versus-

1. The State of Jharkhand

2. Sumant Kumar Tiwary, Drug Inspector, Dumka/Deoghar, District- Dumka … Opposite Parties

With

Cr.M.P. No. 1969 of 2011

M/s. Chilika Pharmacheuticals Pvt. Limited, Deoghar through its Managing Director Ramesh Kumar Singh … Petitioner -Versus-

The State of Jharkhand … Opposite Party -----

CORAM: HON'BLE MR. JUSTICE SANJAY KUMAR DWIVEDI -----

For the Petitioners : Mr. Jitendra Shankar Singh, Advocate (In both cases) Ms. Shabina Perween, Advocate

Ms. Sonu Kumari, Advocate

For the State : Mr. Azeemuddin, A.P.P. (In Cr.M.P.-741/2011) Mr. Jitendra Pandey, A.P.P. (In Cr.M.P.-1969/2011)

-----

12/21.09.2023 In both the cases, common question of facts and laws are involved and that is why, both the cases have been heard together with consent of the parties.

2. Heard Mr. Jitendra Shankar Singh, learned counsel for the petitioners in both the cases and Mr. Azeemuddin and Mr. Jitendra Pandey, learned counsel for the State in Cr.M.P. Nos.741 of 2011 and 1969 of 2011 respectively.

3. Cr.M.P. No.741 of 2011 has been filed for quashing the entire criminal proceeding arising out of Jasidih P.S. Case No.8 of 2011, dated 07.01.2011, corresponding to G.R. Case No.35 of 2011, pending in the court of the learned Chief Judicial Magistrate, Deoghar.

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4. Jasidih P.S. Case No.8 of 2011 was lodged by opposite party no.2 alleging therein that the informant received information from CBI, Ranchi that their two officers would make verification of medicines in the factory of some medicine manufacturer. On 14.05.2010 in the presence of CBI officers, samples of aromatic cardamom Tincture, Belladonna Tincture were taken which were sealed in presence of the CBI officers and sent for test/analysis to the Government Analyst. It was further alleged that as per the test report dated 30.12.2010, 24.12.2010 the samples were found to be not of standard quality which comes under the category of spurious drugs which is punishable under Sections 27(b) and 27(d) of the Drugs and Cosmetics Act, 1940 (hereinafter to be referred to as "the Act, 1940").

5. Cr.M.P. No.1969 of 2011 has been filed for quashing the entire criminal proceedings including the order dated 23.06.2011 passed by the learned Chief Judicial Magistrate, Deoghar in GOCR No.72 of 2011, corresponding to T.R. Case No.750 of 2011, pending in the court of the learned Chief Judicial Magistrate, Deoghar.

6. GOCR No.72 of 2011 was filed alleging therein that on 14.05.2010 in the presence of CBI officers, samples of aromatic cardamom Tincture, Belladonna Tincture were taken by Sumant Kumar Tiwari, the then Drug Inspector which were sealed in presence of the CBI officers and sent for test/analysis to the Government Analyst. It was further alleged that as per the test report dated 30.12.2010, 24.12.2010 the samples were found to be not of standard quality which comes under the category of spurious drugs which is punishable under Sections 27(c) of the

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Act, 1940.

7. Mr. Jitendra Shankar Singh, learned counsel for the petitioners submits that the FIR was registered against the petitioners in absence of the company. He further submits that the Cr.M.P. No.741 of 2011 was heard by this Court and stay was granted in favour of the petitioners vide order dated 15.06.2011 and, thereafter, the complaint case being GOCR No.72 of 2011 was filed arraying the company as one of the accused. He submits that to fill up the lacuna of lodging of the FIR, the said complaint case was filed on the same facts. He also submits that the said complaint case was filed on 18.06.2011 wherein the petitioner and company has been made accused. He submits that the report of the Government Analyst is dated 31.01.2011, contained in Annexure-B2 of Cr.M.P. No.1969 of 2011 and the analysis was made between 03.08.2010 and 20.08.2010. By way of referring the analysis report, he submits that it has not come in the report that the drug in question was spurious. He submits that at best even the analysis report is accepted, it can be a case of sub-standard drug. He further submits that Section 16 of the Act, 1940 speaks of standards of quality. He also submits that in view of second schedule in light of Sections 8 and 16 of the said Act, nothing has come on record to suggest what has not been complied as a standard drug. He further submits that in view of Section 17B of the Act, 1940, spurious drugs are defined and analysis report is not coming within any of the conditions made in Section 17B of the said Act. He submits that the said drug was not displayed in any of the pharmaceutical distributor. The drug was seized from the premises of the company. He further refers Sub-section (c) of Section 18 of the Act, 1940

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and submits that there was no violation. By way of referring Sub-section (3) of Section 25 of the said Act, 1940, he submits that the valuable right of the petitioners has been snatched as the drug sample was not provided to the petitioners in view of Sub-section (3) of Section 25 of the said Act. He further submits that Section 27(c) of the said Act, 1940 speaks of penalty of drug which comes within spurious drugs under Section 17B of the said Act. He also submits that in view of analysis report itself that drug is not coming within the meaning of Section 17B, the cognizance order is bad in law in view of Sub-section (c) of Section 27 of the Act, 1940. He further submits that this aspect of the matter, so far as Section 23 and 25 of the Act, 1940 are concerned, that is set at rest in view of the judgments passed by the Hon'ble Supreme Court as well as of this Court. He relied upon the judgment passed by the Hon'ble Supreme Court in the case of Glaxo Smith Kline Pharmaceuticals Ltd. and Another v. State of Madhya Pradesh, AIR 2011 SC 2998. Paragraph nos. 7 and 11 of the said judgment read as under:

"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 ., 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

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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 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."

8. On these grounds, Mr. Jitendra Shankar Singh, learned counsel for the petitioners submits that the entire criminal proceeding of the FIR as well as the complaint case may kindly be quashed.

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9. Mr. Azeemuddin and Mr. Jitendra Pandey, learned counsel for the State jointly submit that what has been argued by the learned counsel for the petitioners i.e. the dispute in question and that can only be appreciated by the learned Court in course of trial. They further submit that the counter affidavit has been filed, wherein, it has been disclosed that the drug in question was seized and the procedure of the Act, 1940 has been followed and in view of that, no case of interference is made out.

10. In view of the above submissions of the learned counsel for the parties, the Court has gone through the materials on record and finds that admittedly the FIR being Jasidih P.S. Case No.8 of 2011, dated 07.01.2011 was registered and vide order dated 15.06.2011 in Cr.M.P. No.741 of 2011, stay was granted by this Court, thereafter, the complaint case being GOCR No.72 of 2011, dated 18.06.2011 was filed, which suggests that only to fill up the lacuna, second case being complaint case was filed. In the FIR, the company was not made accused. Further, the Act provides that only the complaint can be entertained, as has been held by the Hon'ble Supreme Court in the case of Union of India v. Ashok Kumar Sharma and others, reported in (2011) 12 SCC 674.

11. Admittedly, the analysis report is dated 31.01.2011, wherein, the period of analysis is shown to be 03.08.2010 to 20.08.2010 and in the remarks column, it has been disclosed that the identification of Cinnamon Oil and Clove Oil could not be done due to non-availability of reference standard. Further, it appears that description, identification and weight per milliliter are found to be correct. In view of this, the drug in question is

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spurious, that is not established.

12. Further Section 17B of the Act, 1940 speaks of spurious drugs, which reads as under:

"17B. Spurious drugs.—For the purposes of this Chapter, a drug shall be deemed to be spurious,—

(a) if it is manufactured under a name which belongs to another drug; or

(b) if it is an imitation of, or is a substitute for, another drug or resembles another drug in a manner likely to deceive or bears upon it or upon its label or container the name of another drug unless it is plainly and conspicuously marked so as to reveal its true character and its lack of identity with such other drug; or

(c) if the label or container bears the name of an individual or company purporting to be the manufacturer of the drug, which individual or company is fictitious or does not exist; or

(d) if it has been substituted wholly or in part by another drug or substance; or

(e) if it purports to be the product of a manufacturer of whom it is not truly a product."

13. Looking to the above criteria of spurious drug, none of the Act with regard to analysis report is coming within the aforesaid criteria. In view of that, it cannot be said that the drug in question was spurious. Second schedule speaks of standard to be maintained and it appears that such standard has been maintained.

14. Further, Sub-section (3) of Section 25 of the Act, 1940 has not been followed and in view of that substantial right of the petitioners has been snatched, which is against the mandate of law, as has been held by the Hon'ble Supreme Court in the case of Glaxo Smith Kline Pharmaceuticals Ltd. (supra).

15. In view of the above facts, reasons and analysis, the entire criminal proceeding arising out of Jasidih P.S. Case No.8 of 2011, dated 07.01.2011, corresponding to G.R. Case No.35 of 2011, pending in the court of the

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learned Chief Judicial Magistrate, Deoghar as well as the entire criminal proceedings including the order dated 23.06.2011 passed by the learned Chief Judicial Magistrate, Deoghar in GOCR No.72 of 2011, corresponding to T.R. Case No.750 of 2011, pending in the court of the learned Chief Judicial Magistrate, Deoghar are quashed.

16. Accordingly, these petitions are allowed and disposed of.

(Sanjay Kumar Dwivedi, J.)

Ajay/ A.F.R.

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