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Punjab-Haryana High Court

M/S Jacksons Laboratories Pvt. Limited ... vs District Drugs Inspector on 13 August, 2012

Crl. Misc. No.M-2664 of 2012                                1
                     ..
IN THE HIGH COURT OF PUNJAB AND HARYANA AT CHANDIGARH


                     Criminal Misc. No. M-2664 of 2012 (O&M)
                     Date of Decision : August 13th, 2012


M/s Jacksons Laboratories Pvt. Limited and another
                                                .... Petitioners

                               Versus

District Drugs Inspector, Amritsar
                                                  .... Respondent

CORAM : HON'BLE MR. JUSTICE VIJENDER SINGH MALIK

1.Whether Reporters of local papers may be allowed to see the judgment?
2.Whether to be referred to the Reporters or not?
3.Whether the judgment should be reported in the Digest?

Present     Mr. Sandeep Wadhawan, Advocate,
           for the petitioners.

           Mr. Mikhail Kad, AAG, Punjab,
           for the State.

VIJENDER SINGH MALIK, J.

This is a petition brought under the provisions of section 482 Cr.P.C. for quashing of complaint No. 28 of 2007 dated 1.2.2007 titled as State through District Drug Inspector, Amritsar Versus Jugal Kishore and another, pending in the court of learned Chief Judicial Magistrate, Amritsar for an offence punishable under section 18(1)(i) read with section 27(c) of the Drugs and Cosmetics Act, 1940 (for short, "the Act") and all consequential proceedings arising therefrom including the order dated 12.2.2007 (Annexure P10), whereby the petitioners have been summoned to face trial, being against the spirit and tenor of the Act as also the law laid down by Hon`ble Supreme Court of India and is, Crl. Misc. No.M-2664 of 2012 2 ..

therefore, gross abuse of the process of law.

The facts, in brief, are are the petitioners are manufacturing drugs. A drug by name, Polyvit (multi vitamin tablet) batch No. T-2287 was manufactured by the petitioners. Some of the said tablets were supplied to Bara Hindu Rao Hospital, Delhi - 110 007. The sample of the said tablet was collected by Sh. Arvind Kukrety, an Inspector appointed under section 21 of the Act (for short, "the Drugs Inspector") on 6.4.2005 from the said hospital. Sample of the same tablet was also collected by the Drugs Inspector Sh. Dinesh Kumar Chauhan from M/s Jacksons Laboratories Pvt. Limited (for short, "the Laboratory") at Amritsar. The drug purchased for analysis was divided into four portions, was sealed and sent to Central Drugs Laboratory, Kolkata. Annexure P1 is the certificate of test or analysis by Government Analyst under section 25 (1) of the Act regarding the drug seized from Bara Hindu Rao Hospital, Delhi and Annexure P5 is another certificate for the tablets seized from the Laboratory. As both the reports had been to the effect that the sample did not conform to the claim made regarding the contents of the tablets in respect of vitamin A and folic acid, the complaint was made against the petitioners in the court of learned Chief Judicial Magistrate, Amritsar, for the aforesaid offence.

I have heard Mr. Sandeep Wadhawan, learned counsel for the petitioners and Mr. Mikhail Kad, learned AAG, Punjab for the State. I have gone through the record carefully.

Learned counsel for the petitioners has submitted that the right of the petitioners under sections 25(3) and 25(4) of the Act has been violated by the complainant in this case by not sending the sample for re- Crl. Misc. No.M-2664 of 2012 3

..

testing to Director, Central Drugs Laboratory and, therefore, the petitioners are deprived of their valuable right and this prosecution cannot continue. In this regard, he has cited before me a decision of Hon`ble Supreme Court of India in M/s Medicamen Biotech Ltd. & Anr. Vs. Rubina Bose, Drug Inspector, 2008 (2) RCR (Crl.) 496, where the sample sent to Government Analyst for analysis was declared sub- standard and despite the accused sending two communications to the Drugs Inspector for sending the 4th part of the sample to Central Drugs Laboratory for re-testing, no action was taken. The complaint was also filed in the court about a month earlier to the expiry date of shelf life of the drug when it was impossible to get the sample tested before the date of expiry. It was held that the accused had 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.

Learned State counsel on the other hand has submitted that when the sample is sent to Central Drugs Laboratory for analysis, the provisions of section 25(4) of the Act lay down no direction for re-testing and that the report of Central Drugs Laboratory is to be deemed as final in the matter. He has placed reliance on another decision of Hon`ble Supreme Court of India in Ram Shankar Misra Vs. State of U.P. 1980 Crl. L.J 820, where the provisions of section 25(4) of the Act have been discussed and it has been held that if the sample is sent to Director of Central Drugs Laboratory, the report of the Director shall be final.

Section 25(3) of the Act deals with two aspects. The first is about the conclusive nature of evidence about the facts mentioned in a Crl. Misc. No.M-2664 of 2012 4 ..

document purporting to be a report signed by a Government Analyst under this chapter. An exception to this section is the other aspect, that is dealt with in this very sub-section, which is to the effect that it will not be conclusive if the person from whom the sample was taken or the person whose name, address and other particulars have been disclosed under section 18A of the Act has notified in writing the Inspector or the court before which any proceedings are pending, of his intention to adduce evidence in controversion of the report. It is, however, a condition in this exception that the Inspector or the court has to be notified in writing of such intention within twenty-eight days of the receipt of a copy of the report.

Section 25(4) of the Act deals with the finality of the report of Central Drugs Laboratory and lays down that if the report is of Government Analyst, then the person from whom the sample was taken has a right to get the 4th portion of the sample re-tested from the said laboratory, the result of which would be conclusive evidence of the facts stated therein.

The reports before me are Annexures P1 and P5. Both are certificates of test or analysis by Government Analyst and not by the Director. It is clearly mentioned in these documents, which are in form No. 13, that they have been made under rule 46 of the the Drugs and Cosmetics Rules, 1945 (for short, "the Rules") and not under rule 6 of the Rules which relates to the report by the Director. After receipt of this report, the Drugs Inspector wrote to Government Analyst vide Annexure P2 which is regarding non declaration of result of three drugs, the samples of which were also taken. Vide Annexure P3, dated 10.3.2006, Crl. Misc. No.M-2664 of 2012 5 ..

Arvind Kukrety, Drugs Inspector wrote to the Laboratory with regard to the report of Government Analyst telling the Laboratory about the further proceedings intended to be brought as well as some other aspects. Vide Annexure P4 dated 20.3.2006 the petitioners notified the Drugs Inspector of their intention to get the 4th part of the sample to be re- tested. Similar is the document, Annexure P/6 written by D.K.Chauhan, Drugs Inspector to Jugal Kishore, Managing Director of the petitioner laboratory telling about the result of the analysis of the sample of polyvit and Annexure P7 is the letter written by the Laboratory to the Drugs Inspector notifying their intention to get the 4th part of the sample re- tested.

Now, despite the fact that the petitioners notified the Drugs Inspector well within twenty-eight days as provided under section 25(3) of the Act of their intention to get the sample re-tested, no action was taken by the Drugs Inspectors in sending the 4th part of the sample to Director, Central Drugs Laboratory. The complaint, Annexure P9 admittedly bears 1.2.2007 as the date under it and the order of learned Chief Judicial Magistrate summoning the petitioners in this complaint is dated 12.2.2007. From the documents, it can be said that the complaint has been filed on or about 1.2.2007. Now, the question arises as to what was the date of expiry of shelf life of the drugs in question. Annexure P2, a communication by Drugs Inspector to Government Analyst itself mentions the expiry date of Polyvit (multi vitamin tablet) as August, 2006. This shows that the complaint was filed much after the expiry of the date of expiry of shelf life of the tablet. So, the complaint was filed much after the expiry date of shelf life of the drug, depriving the petitioners of their Crl. Misc. No.M-2664 of 2012 6 ..

right to get the tablet re-analysed. The Inspectors did not take any action on being notified by the petitioners not once but twice in the direction of getting the sample re-tested from Director, Central Drugs Laboratory.

In Ram Shankar Misra's case (supra), the first sample itself was sent for analysis to Director, Central Drugs Laboratory and it was analysed by Director himself. Once the sample is analysed by the Director, no further right is there with the person from whom sample is taken to get the drug re-analysed because the report of the Director is final. In the case in hand, the drug has been analysed by Government Analyst and the right was there with the petitioners to get the sample re- analysed from the Director, which right has been knowingly taken away from the petitioners. The facts of this case squarely attract the ratio of M/s Medicamen Biotech Ltd.'s case (supra) and the facts of the case before me justify quashing of the proceedings. Consequently, I accept the petition and quash complaint No. 28 of 2007 dated 1.2.2007 titled as State through District Drug Inspector, Amritsar Versus Jugal Kishore and another pending in the court of learned Chief Judicial Magistrate, Amritsar for an offence punishable under section 18(1)(i) read with section 27(c) of the Act and all consequential proceedings arising therefrom including the order dated 12.2.2007 (Annexure P10) .

(VIJENDER SINGH MALIK) JUDGE August 13th, 2012 som