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2014 DIGILAW 4628 (MAD)

Eurokem Laboratories Private Limited v. State

2014-12-19

S.NAGAMUTHU

body2014
ORDER S. Nagamuthu, J. 1. The petitioners are the accused in C.C. No. 16 of 2008 on the file of the learned Chief Judicial Magistrate, Chengalpet. The respondent has laid a private complaint alleging that the petitioners have contravened Section 18(a)(1) of the Drugs and Cosmetics Act, 1940 (hereinafter referred to as, "the Act") and thus, they are punishable under Section 27(d) of the said Act. Seeking to quash the said proceedings, the petitioners are before this Court with this petition. I have heard the learned Counsel for the petitioners and the learned Additional Public Prosecutor appearing for the respondent. I have also perused the records carefully. 2. The case of the prosecution is as follows: The 1st petitioner is a company and a manufacturer of drugs. The 2nd and 3rd petitioners are Directors of the said company and the 4th petitioner is the Quality Control Chemist of the 1st accused company. An inspection was carried out at the business place, by the competent authority in the premises of the petitioner's company along with one M.M. Yousuf, Assistant Director of Drugs Control, Zone IV and Mr. Bangarurajan, Drugs Inspector, Intelligence Wing and Ms. Tamil Selvi, Director of Drugs Control, Chennai on 10.10.2006. A sample of drug (Paracet-omal Syrup) Batch No. Q-90, M/D:04/2006, E/D:03/2008 manufactured by the 1st petitioner was drawn as a sample for analysis. It was sent for analysis through Government Analyst (Drugs), Chennai-9 under Form-18. The Government Analyst, Drugs Testing Laboratory, Chennai, submitted a report under Report No. 01755-D2006-07 wherein he has stated that the sample received in a bottle with original label pasted on it containing the description pink colour syrup liquid contains white floating particles. The report further stated that the sample answered the identification test for Paracetamol conforms to IP specification. The report also stated that the sample does not conform to general requirement for liquid oral dosage forms in respect of description and does not conform to Schedule V of Drugs and Cosmetic Act in respect of volume. On receipt of the report, the respondent issued a show cause notice to the accused along with a copy of the report. 3. The petitioners submitted a reply on 29.06.2007 stating that all the supplies made to the Tamil Nadu Medical Service Corporation Limited were subjected to quality test before acceptance and they have not received any complaint initially. On receipt of the report, the respondent issued a show cause notice to the accused along with a copy of the report. 3. The petitioners submitted a reply on 29.06.2007 stating that all the supplies made to the Tamil Nadu Medical Service Corporation Limited were subjected to quality test before acceptance and they have not received any complaint initially. It was also stated that after storage of the same, some sediments might have developed which is not the prescription of the active ingredient Paracetamol. It was also stated that these floating particles are agglomeration of polyglycols used in the formulation. It was further stated that it is no way harmful and does not affect the efficiency of the drug. They have also stated that now they have stopped production till they further stabilise the formulation. Having been not satisfied with the said reply, the respondent laid a private complaint before the learned Chief Judicial Magistrate, Chengalpattu and cognizance has been taken on the same by the learned Magistrate. 4. In the present case, the allegation is that so far as the description found in the label is concerned, it contravenes Section 18(1)(a) of the Act. The description is that the drug is a Syrup. According to the respondent, the syrup should be a homogeneous liquid and it should not contain any sediment or floating particles. Thus, the presence of white floating articles in the liquid, does not indicate that it was a syrup. Therefore, according to the respondent, it is a contravention of Section 18(a)(1) of the Act. 5. But the learned Counsel for the petitioners would vehemently submit that the term "Prescription" has not been described either in the Act or in the Rules. He would further submit that the presence of white floating particles will not be harmful to health and as stated in the reply, these floating particles are agglomeration of polyglycols used in the formulation and thus white floating particles had occurred since the products were kept for 9 months in storage. The learned Counsel for the petitioners would further submit that even according to the Analyst Report, the drug conform to the standard inasmuch as the Paracetamol content was 97.62% whereas the requirement is 95-105%. According to the Analyst Report, the paracetamol content was 97.62%). Thus, according to the learned Counsel for the petitioner, there was no contravention in respect of the description. 6. According to the Analyst Report, the paracetamol content was 97.62%). Thus, according to the learned Counsel for the petitioner, there was no contravention in respect of the description. 6. In my considered opinion, the said contention cannot be accepted in this case. As rightly pointed out by the learned Counsel for the petitioners, the term "description" is not a technical term requiring any definition at all either in the Act or in the Rules. The term "prescription" in common parlance means narration of the contents of drug. Admittedly, the label which contains the description of the contents of the drug mentioned in the same is a syrup. In Indian Pharmacopoeia, they have stated that Syrup means oral liquids or homogeneous liquid preparations. It means that there should be neither a sediment nor any floating particles. It may be true that in a given case, the floating particles are not harmful to health. At this juncture, we need to notice that it is not the accusation that the drug was adulterated and it did not conform to the standard. The accusation is, in simple terms, wrong description of the contents. As per the Indian Pharmacopoeia, as I have already stated, syrup means a homogeneous liquid which should not have any sediment or floating particles. 7. In this case, according to the Analyst Report, there were white floating particles and therefore, it is not a syrup at all. Thus, the description of the label is in contravention of Section 18(a)(1) of the Act which states that if the drug is misbranded it is a contravention. Here though the content of the bottle is not a syrup because of the presence of the floating particles, it was branded as a syrup and therefore, it is misbranded. Thus, prima-facie I am satisfied that there is violation of Section 18(a)(1) of the Act. In view of the same, the first contention of the learned Counsel for the petitioners is rejected. 8. Secondly, the learned Counsel for the petitioners would submit that valuable right of the petitioners to take the sample for analysis by the Central Laboratory has been deprived of. According to him, the complaint itself was presented after the expiry of the period of the drugs and thus, the petitioners were deprived of, the right to have the sample analysed by the Central Lab. According to him, the complaint itself was presented after the expiry of the period of the drugs and thus, the petitioners were deprived of, the right to have the sample analysed by the Central Lab. The learned Counsel for the petitioners would refer to section 25(4) of the Act. A perusal of Section 25(3) of the Act would go to show that on receipt of the Analyst Report from the Inspector, if the petitioners had wanted it to have the second sample tested by the Central Laboratory, they should have expressed their intention to have such second analysis by the Central Laboratory to the Inspector. Thereafter only, they can make an application under Sub-section 4 of Section 25 of the Act to forward the sample to the Central Laboratory. 9. In the case on hand, the petitioners, though had sent reply disputing the correctness of the Analysis Report, did not express their intention to forward the sample for second testing. Therefore, in my considered opinion, the petitioners do not have any right to now say that a chance to forward the sample for second analysis has been deprived of. In this regard, I would refer to a judgment of the Hon'ble Supreme Court in State of Haryana v. Brij Lal Mittal AIR 1998 SC 2327 : (1998) 5 SCC 353 : LNIND 1998 SC 519 wherein in paragraph 5, the Hon'ble Supreme Court has held as follows: "5. From a bare perusal of sub-section (3) it is manifest that the report of the Government Analyst 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 or other particulars have been disclosed under Section 18A (in this case the manufacturers) has within 28 days of the receipt 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. Sub-section (4) also makes it abundantly clear that the right to get the sample tested by the Central Government Laboratory (so as to make its report override the report of the Analyst) through the court accrues to a person accused in the case only if he had earlier notified in accordance with sub-section (3) his intention of adducing evidence in contravention of the report of the Government Analyst. To put it differently, unless requirement of sub-section (3) is complied with by the person concerned, he cannot avail of his right under sub-section (4)." (Emphasis) As has been very categorically held by the Hon'ble Supreme Court since in the instant case, the petitioners did not express their intention as required under Sub-section 3 of Section 25 of the Act to send the second sample tested by the Central Laboratory, they do not have any right to now say that no chance for forwarding the second sample to the Central Laboratory was given. 10. The contention of the learned Counsel for the petitioners that though it was true that the petitioner did not express their intention to have the sample analysed by the Central Laboratory as provided under Section 3 of Section 25(3) of the Act, the respondent ought to have presented the complaint before the expiry period of the drugs so that the petitioners could have approached the Magistrate under Sub-section 4 of Section 25 of the Act for forwarding the 2nd sample for testing, is not legally sustainable. 11. In my considered opinion, the above argument needs only to be rejected for the simple reason that the right to ask for sending the 2nd sample for testing occurs if only there had already expression of intention to have the sample tested by the Central Laboratory as provided under Sub-section 3 of Section 25 of the Act. Therefore, it is immaterial that the complaint was presented after the expiry of the drugs. The learned Counsel for the petitioners have relied on a judgment of this Court in Kausalya Pharmaceuticals rep. by Mr. D. Suri Shankar, the Managing Director of the Company and Others v. State rep. by the Drugs Inspector, Chengalpattu Range, 15C Shelkpet North Stree, Kancheepuram, Crl. R.C. 125 of 2010 dated 26.02.2010 wherein this Court has quashed the proceedings on the ground that the complaint was presented after the expiry of the drugs. by Mr. D. Suri Shankar, the Managing Director of the Company and Others v. State rep. by the Drugs Inspector, Chengalpattu Range, 15C Shelkpet North Stree, Kancheepuram, Crl. R.C. 125 of 2010 dated 26.02.2010 wherein this Court has quashed the proceedings on the ground that the complaint was presented after the expiry of the drugs. A perusal of the said judgment would go to show that it was not a case that the intention to have the test was not expressed under Section 25(3) of the Act. Therefore, that judgment is not at all applicable to the case on hand. In view of all the above, I do not find any merit in this petition. In the result, the Criminal Original Petition fails and the same is accordingly dismissed. Consequently, connected Miscellaneous Petitions are also closed.