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2016 DIGILAW 1809 (RAJ)

Lupin Limited v. State of Rajasthan

2016-12-14

PRATAP KRISHNA LOHRA

body2016
ORDER : Pratap Krishna Lohra, J. 1. Petitioner-company, incorporated under the Indian Companies Act, 1956, has preferred this criminal misc. petition for seeking quashment of the entire proceedings in Criminal Case No. 102/2011, pending before Sessions Judge, Bikaner (for short, 'learned trial Court'). 2. The facts, in brief, giving rise to this petition are that a complaint came to be filed against petitioner Company under Sections 27(b)(i) and 27(d) of the Drugs and Cosmetics Act, 1940 (for short, 'Act') before the learned trial Court, inter-alia, alleging therein that on 10th of September 1999 Drug Inspector inspected the premises of M/s. Bikaner Sahakari Upbhokta Wholesale Bhandar Limited at Indira Market and purchased Rifampicin capsule of brand name R-CIN-600 having Batch No. 907 with the date of manufacturing July 1999 and expiry date of June 2001. Said capsule was sampled as per the provisions of the Act and thereafter sent for analysis to the Central Drugs Laboratory, Kolkata. The Central Drugs Laboratory, Kolkata, by its report dated 28th of August 2000, found the sample to be sub-standard not conforming to Indian Pharmacopoeia (I.P.). On receipt of the report, the same was forwarded to the vendor, who is arrayed as accused No. 2 in complaint, and thereafter usual proceedings as per the Act initiated and when it was revealed that manufacturer of the drug in question is petitioner-Company, a copy of the report was endorsed to it on 21st of April 2001. The petitioner-Company, immediately after receiving the report, on 30th April 2001 informed the Drug Inspector that the report is not acceptable to it. The petitioner-Company further clarified to the Drug Inspector that it intends to adduce evidence in controversion of the report. Be that as it may, no endeavour was made by the Drug Inspector to acknowledge the communication sent by petitioner-Company for almost seven months and ultimately on its behalf an application under Section 25(4) of the Act was filed before Chief Judicial Magistrate, Bikaner on 27th of November 2001, which was almost five months after expiry of the sample. Pursuant to the said application, sample was forwarded and on re-analysis the report was received on 24th of April 2002. In the said report, the Analyst desisted from giving any opinion regarding the sample precisely by citing the reason that sample was received after the date of expiry. Pursuant to the said application, sample was forwarded and on re-analysis the report was received on 24th of April 2002. In the said report, the Analyst desisted from giving any opinion regarding the sample precisely by citing the reason that sample was received after the date of expiry. Therefore, no opinion was expressed by the Analyst in connection with standard and quality of the said sample. Subsequent to the receipt of report dated 24th April 2002, requisite sanction was accorded for filing prosecution against responsible persons of the Company after soliciting their names from Food & Drugs Commissioner, Maharashtra. Finally, the complaint was filed in the Court on 1st of July 2006. 3. Learned counsel for the petitioner, Mr. Vineet Jain, has strenuously urged that in the instant case denial of right to the petitioner-Company to adduce evidence in controversion of the Central Drugs Laboratory report despite notifying its objection in writing within the stipulated period, has vitiated the entire proceedings. Learned counsel, Mr. Jain, would contend that a valuable right of the Company to adduce evidence in controversion of the report envisaged under sub-sec. (3) & (4) of Section 25 of the Act is clearly abrogated inasmuch as when the sample was sent for re-analysis it had already expired. Learned counsel, therefore, submits that in view of denial of legitimate right of defence to the petitioner-Company, allowing proceedings to continue in the matter would be a sheer abuse of the process of the Court. In support of his contentions, learned counsel for the petitioner has placed reliance on following judgments: (i) State of Haryana v. Brij Lal Mittal & Ors., 998 SCC (Cri.) 1315 (ii) M/s. Cadila Health Care Ltd. v. The State of Rajasthan & Ors., 2007 Cri. L.J. 1899. 4. Per contra, learned Public Prosecutor submits that the first report of Central Drugs Laboratory is clear and unequivocal showing the sample to be of sub-standard as per the norms of IP, therefore, no interference with the pending criminal proceedings against the petitioner-Company is warranted. Learned Public Prosecutor would contend that in the instant case there is no question of violation of Section 25(3) of the Act and as such, there is apparently no reason to countenance miscarriage of justice. Learned Public Prosecutor would contend that in the instant case there is no question of violation of Section 25(3) of the Act and as such, there is apparently no reason to countenance miscarriage of justice. Lastly, learned Public Prosecutor has urged that the proceedings are pending since 2006 and therefore it is not desirable to exercise inherent jurisdiction in the matter for annulment of the same. 5. I have heard learned counsel for the petitioner as well as learned Public Prosecutor and perused the materials available on record. 6. While it is true that under Section 27, a manufacturer for sale or for distribution of drug is liable for prosecution if the drug is found to be adulterated under Section 17-A, for offence under clause (b)(i) of Section 27 of the Act, and can be penalized in terms of Section 27(d) but then an incumbent, manufacturer or responsible for sale of the drug, cannot be denied reasonable opportunity to defend. The Legislature in its wisdom has made an affirmative attempt to safeguard the rights of manufacturer or seller of the drug by permitting them to adduce evidence in controversion of the report and said right is available to a manufacturer or a seller subject to the condition that on their behalf it is notified in writing to the Inspector or the Court in this behalf within 28 days of receipt of copy of the report. For convenience, sub-sec. (3) & (4) of Section 25 of the Act reads as under: (3) Any document purporting to be a report signed by a Government Analyst under this Chapter shall be evidence to 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 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. 7. In that background, if the report of Central Drugs Laboratory is examined, then, it would ipso facto reveal that the same was received by Drug Inspector on 28th of August 2000 and was forwarded to the petitioner-Company on 21st of April 2001. 7. In that background, if the report of Central Drugs Laboratory is examined, then, it would ipso facto reveal that the same was received by Drug Inspector on 28th of August 2000 and was forwarded to the petitioner-Company on 21st of April 2001. In response to the same, petitioner-Company has addressed a letter to the Drug Inspector on 30th April 2001 notifying in writing that it intends to adduce evidence in controversion of the report. However, the sample was sent for re-analysis by the Drug Inspector after its expiry. Therefore, taking into account the vital fact that the sample had already expired, the Central Drugs Laboratory declined to give any report in the matter regarding standard and quality of the sample. This fact is clearly discernible from the report of Central Drugs Laboratory dated 24th of April 2002. The relevant recitals in this behalf of the report read as under: Remarks : No opinion could be given regarding the standard and quality of the sample under Drugs & Cosmetics Acts & Rule as the sample was received and tested after the date of expiry (June 2001). 8. In this view of the matter, right to controvert the report of Central Drugs Laboratory, on which the Drug Inspector has placed reliance, has been completely denied to the petitioner-Company and this important fact cannot be overlooked by this Court in view of mandatory provision contained in sub-sec. (3) & (4) of Section 25 of the Act, as such, further proceedings, in the considered opinion of this Court, are clearly vitiated in law. My aforesaid view is also fortified by the two judgments, on which the learned counsel for the petitioner has placed reliance. 9. Supreme Court in Brij Lal Mittal & Ors. (supra) has examined the provisions of sub-sec. (3) of Section 25 of the Act threadbare and clarified the legal position as to when a manufacturer or a seller can be allowed to take shelter of the right of controversion under the aforesaid provision. 9. Supreme Court in Brij Lal Mittal & Ors. (supra) has examined the provisions of sub-sec. (3) of Section 25 of the Act threadbare and clarified the legal position as to when a manufacturer or a seller can be allowed to take shelter of the right of controversion under the aforesaid provision. The Court held: "At the risk of repetition, we wish to emphasis that the right to get the sample examined by the Central Drugs Laboratory through the Court before which the prosecution is launched arises only after the person concerned notifies in writing the Inspector or the Court concerned (here the latter clause did not apply for the prosecution was set to be initiated) within twenty-eight days from the receipt of the copy of the report of the Government Analyst that he intends to adduce evidence in controversion of the report. The complaint and its accompaniments (which include correspondences that took place between the Inspector and the manufacturers) clearly disclose that on 19/02/1991 the Inspector served the original copies of the Analyst's report upon the Managing Director of the manufacturers along with two letters asking for their comments. They further disclose that receiving no reply from the manufacturers the Inspector again wrote a letter on March 6, 1991 directing them to reply to his letters dated 19/02/1991 and asked whether they wanted to take benefit of the provisions of Section 25(3) of the Act. Inspite thereof the manufacturers did not exercise their right (much less within 28 days from the date of the receipt of the report of the Government Analyst i.e. 19/02/1991); and, on the contrary, in their letter dated April 8, 1991 (annexed to the complaint), sent in response to the letter dated March 6, 1991, asserted that their quality control department examined and tested samples of the two drugs and found that they complied with the test of sterility. It must, therefore, be said that consequent upon their failure to notify the Inspector that they intended to adduce evidence in controversion of the report within 28 days, not only the right of the manufacturers to get the sample tested by the Central Drugs Laboratory through the Court concerned stood extinguished but the report of the Government Analyst also became conclusive evidence under Sub-section (3). The delay in filing the complaint till the expiry of the shelf life of the drugs could not, therefore, have been made a ground by the High Court to quash the prosecution. It will not be out of place to mention that the manufacturers' right under Sub-section (3) expired four months before the expiry of the shelf life of the drugs. In view of the above discussion, the reasoning of the High Court for quashing the prosecution against the three respondents cannot at all be sustained. 10. In the instant case, as the objection is notified by petitioner-Company within stipulated period of 28 days and the rigor of sub-sec. (3) and sub-sec. (4) of Section 25 of the Act clearly applies thereby bringing the entire proceedings under serious cloud. 11. In M/s. Cadila Health Care Ltd. (supra), Division Bench of this Court had the occasion to examine the said issue and while acknowledging the right of a manufacturer or seller under sub-sec. (3) of Section 25 of the Act to adduce evidence in controversion of the report, the Court held: 30. In an unreported judgment in M/s. Gupta Chemicals Pvt. Ltd. & Ors. v. State of Rajasthan & Anr. Criminal No. 591/2002 2002 (4) Crimes 33, Supreme Court has held that a valuable right of the appellant to move the Magistrate for appropriate order for the purpose of re-testing from Central Insecticides Laboratory is lost on account of filing complaint after expiry of the shelf life. Relevant observations of the Supreme Court are as under: "As noted earlier, in the present case, the appellants had intimated the Insecticides Inspector their intention to have the sample tested in the Central Insecticides Laboratory within the prescribed period of 28 days of the receipt of the copy of the State Analyst; report, yet no step was taken by the Inspector either to send the sample to the Central Insecticides Laboratory or to file the complaint in the Court with promptitude in which case the appellants would have moved the Magistrate for appropriate order for the purpose. The resultant position is that due to sheer inaction on the part of the Inspector, it has not been possible for the appellants to have the sample examined by the Central Insecticides Laboratory and in the meantime, the shelf-life of the sample of insecticide seized had expired and for that reason no further step could be taken for its examination. In the circumstances, we are of the view that continuing this criminal prosecution against the appellant will be a futile exercise and abuse of the process of Court. The High Court was not right in dismissing the petition filed under Section 482 of the Cr.P.C. Accordingly, the appeals are allowed. The orders passed by the High Court are set aside and the prosecution alleged against the appellants are quashed." 12. In view of foregoing discussion, allowing proceedings to continue in the pending criminal case would obviously result in abuse of the process of the Court. Moreover, in the backdrop of facts of the instant case, forcing the petitioner-Company to face further prosecution in the matter may result in miscarriage of justice. 13. Resultantly, instant criminal misc. petition is allowed and the entire proceedings in Criminal Case No. 102/2011 pending before the learned trial Court against the petitioner-Company are hereby quashed and set aside.