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2006 DIGILAW 414 (GAU)

Biodeal Laboratories (P. ) Ltd. v. State of Assam

2006-05-05

P.G.AGARWAL

body2006
JUDGMENT P.G. Agarwal, J. 1. This is an application under Section 482 Cr.P.C. for quashing of the complaint in CR Case No. 208/2002 pending before the Additional Chief Judicial Magistrate, Sonitpur, Tezpur. 2. We have heard Mr. D.K. Mishra, learned senior advocate assisted by Mr. D. Barua, learned Counsel appearing for the petitioner and the learned Public Prosecutor. 3. The petitioner Biodeal Laboratories (P.) Ltd., is the manufacturer of drug Nivaquine-P flavoured suspension. The sample of the said drug was collected by the Inspector of Drugs from the market for analysis and it was sent to the Government Analyst who vide his report dated 1.12.2001 opined that the sample does not comply IP (Indian Pharmacopoeia) with respect to the test for assay. Thereafter the concerned Inspector of Drugs after obtaining necessary sanction submitted offence report against the manufacturer for violation of the provisions of Section 18(a)(i) of the Drugs and Cosmetics Act, 1940 and the rules framed thereunder. The learned Additional Chief Judicial Magistrate took cognizance of the offence and issued process against the petitioners and hence the present application for quashing. 4. The learned Counsel for the petitioners has submitted that the analysis made by the Government Analyst was as per Indian Pharmacopoeia 1996 (IP) but the said IP was not applicable in the present case and as such the analysis was violative of the provisions of Rule 46. 5. We have perused Rule 46 and find that even in cases where the IP is not applicable, a detailed procedure for analysis is provided and in the present case we find that the assay was found to be only 16.3% of the claim made in the drug manufactured and sold by the petitioners and hence in view of the above the prosecution cannot be thrown over board at this stage. 6. 6. The second count on which the quashing of the complaint has been sought is that the report of the Government Analyst to the effect that the drug was 'not of standard quality' was sent to the petitioners by the Inspector of Drugs and thereafter the petitioner-company requested the Inspector of Drugs to send the sample to the Central Drugs Laboratory, Calcutta as provided under Section 25(3) of the Drugs and Cosmetics Act and as the petitioner-company have exercised their discretion within the prescribed time limit of 28 days and as the Inspector of Drugs has failed to send the sample to the Central Drugs Laboratory, the present prosecution is bad in law and requires to be quashed. 7. The learned Counsel for the petitioners has placed reliance on the decision of the Apex Court in the case of State of Punjab v. National Organic Chemical Industries Ltd. (1996) 11 SCC 613 and in the case of State of Haryana v. Brij Lal Mittal 1998 CriLJ 3287. 8. The case of Brij Lal Mittal (supra) was under the Drugs and Cosmetics Act and while considering the scope and ambit of the provisions of Section 25(3) and (4) of the Drugs and Cosmetics Act, the Apex Court had this to say: 7. At the risk of repetition, we wish to emphasise 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 yet 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 accomplishments (which include correspondence that took place between the Inspector and the manufacturers) clearly disclose that on February 19, 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 February 19, 1991 and asked whether they wanted to take benefit of the provisions of Section 25(3) of the Act. 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 February 19, 1991 and asked whether they wanted to take benefit of the provisions of Section 25(3) of the Act. In spite 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., February 19, 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. 9. The learned Counsel for the petitioners has submitted that in the present case the petitioners had informed the concerned authority regarding their intention to get the sample analysed by the Central Drugs Laboratory and for the failure of the concerned authorities to send the sample to the Central Drugs Laboratory the present prosecution cannot be allowed to proceed as it will not serve any useful purpose. 10. The learned Counsel for the respondent, the State on the other hand submits that in the present case the petitioners have admitted that he had received a copy of the analysis report from the Inspector of Drugs as required under the Drugs and Cosmetics Act. 11. 10. The learned Counsel for the respondent, the State on the other hand submits that in the present case the petitioners have admitted that he had received a copy of the analysis report from the Inspector of Drugs as required under the Drugs and Cosmetics Act. 11. The question whether there was any violation of the provisions of Rule 25(3) or (4) as alleged, is a mixed question of fact and law and the same cannot be considered or decided without leading evidence by both the sides or either side. We find that the provisions are identical to Section 13(2) of the Prevention of Food Adulteration Act. Moreover, the question whether the present petitioners/manufacturer had exercised their option within the statutory period of 28 days or not and whether the petitioners had deposited the amount as required for further analysis by the Central Drugs Laboratory are all questions of fact which the petitioners are required to establish to get the benefits of the provisions of Section 25(3) and (4) of the Act. Another aspect of the matter which is relevant for the purpose is that in the meantime the shelf life of the drug has expired and what will be the effect of the same is also required to be considered by the trial court. 12. In view of the aforesaid, we are of the view that no case for quashing of the complaint at this stage is made out. The petitioners shall, however, be at liberty to approach the trial court in the matter at appropriate stage and as and when the question is raised the trial court shall examine the same in the light of the evidence and materials produced before it and pass appropriate orders. 13. The revision petition stands dismissed. Send down the records. Petition dismissed.