Research › Search › Judgment

Andhra High Court · body

2019 DIGILAW 71 (AP)

Parenteral Surgicals Ltd. v. State of Andhra Pradesh

2019-06-04

T.RAJANI, T.RAJANI

body2019
JUDGMENT : T. Rajani, J. 1. This petition is filed seeking for quash of the proceedings against the petitioners, who are A1 to A5, in SC SPL No. 32 of 2018 on the file of the Court of in Additional District & Sessions Judge, Vijayawada, Krishna District. 2. Heard Sri R. Raghunandan, learned Senior Counsel appearing for the petitioners and the Public Prosecutor appearing for the respondent. 3. The complaint filed against the petitioners under Section 32 of the Drugs and Cosmetics Act, 1940 and the Rules, 1945 (for short, "the Act" and "the Rules" respectively), is with the following facts, in brief: The complainant, who was appointed as Drugs Inspector, inspected A1 Company - M/s. Parenteral Surgicals Limited, which had loan licence in Form 20-A, valid upto 13.5.2014. A2 to A5 are the Board of Directors for manufacture of subjected drug alongwith other drugs manufactured by A1 company. All of them are responsible for the day-to-day activities of A1 company. During inspection, the complainant picked up seven types of drugs for testing/analysis by complying with the prescribed procedure. He sent the seized samples to the Government Analyst Drugs Control Laboratory, Hyderabad and the report of the analysts, declaring the said drug as not of standard quality, stating that the sample does not meet L.P. requirement in respect of description of the sample under parental preparation, was received on 31.5.2011. On 1.6.2011, the complainant addressed a letter to L.W. 3, enclosing a copy of the analytical report. L.W. 3 gave a reply on 4.6.2011 to L.W. 1 submitting two stock transfer notes of the subject drug. The complainant addressed a letter dated 6.6.2011 under Section 18-A and 18-B, along with a copy of analytical report in Form 13 dated 26.5.2011, enclosing one of the sealed sample portion of the subject drug and sent the same by registered post to A1 company. On 12.7.2011, investigation was taken up by L.W. 2. On 25.7.2011, L.W. 2 addressed a letter to the Superintendent of Head Post Office, Vijayawada, for non-receipt of acknowledgment card. The receipt of the said notice copy, Form 13 and sample portion by A1 company was confirmed by the reply of the Superintendent of Postal Department. On 14.9.2011, L.W. 2 inspected A1 company and collected the required self-attested documents and relevant information for the subject drug. The receipt of the said notice copy, Form 13 and sample portion by A1 company was confirmed by the reply of the Superintendent of Postal Department. On 14.9.2011, L.W. 2 inspected A1 company and collected the required self-attested documents and relevant information for the subject drug. On 18.6.2012, the complainant addressed a letter to A1 company requesting about any change in the Constitution of Directors asking them to inform the same changes within seven days of the date of receipt of the letter, but no reply was received from A1 company. Considering that A1 to A5 violated Section 18(a)(1) of the Act, the complaint was laid seeking for punishment under Section 27(d) of the said Act. 4. The grounds on which the petitioners now come before this Court seeking for quash are that, the company is manufacturing drugs strictly as per WHO-GMP & revised schedule 'M' requirements and is one of the established manufactures of the Pharma products in the country. The manufacturing process is strictly in accordance with the provisions of the revised schedule M requirements and with in-process control and checks at all the stages of manufacturing. After completion of production, each batch is tested. The petitioner company reviewed the batch manufacturing record of above referred batch and found the same to be of standard quality as per the Quality Control Analytical report dated 26.5.2011 of above referred batch and found that it complies with all parameters as per the specifications. The report shows that only four bottles of the subject drug were taken for testing which were found to be having particles and not of standard quality due to failure in description. The batch is of standard quality and only four bottles developed particles due to mishandling or improper storage conditions and the contention of the petitioner's Counsel is substantiated from the said fact that the sample portion supplied to the applicant company was also in leakage condition. The said fact was brought to the notice and accepted by the complainant Drug Inspector and the same was acknowledged. The failure of the sample portion was mainly due to improper storage or mishandling during the transportation, leading to cracks and it cannot be said to be a ground for failure of the whole batch. The said fact was brought to the notice and accepted by the complainant Drug Inspector and the same was acknowledged. The failure of the sample portion was mainly due to improper storage or mishandling during the transportation, leading to cracks and it cannot be said to be a ground for failure of the whole batch. The petitioners also relied on Clauses 3 and 4 of guidelines, which specifies that in case particular drugs manufactured by licenced manufacturer under a valid licence is found to be grossly sub-standard, only administrative measures are to be taken and the weapon of prosecution is to be used only when administrative measures fail to meet the ends of justice. The report of the Government analyst does not specify as to what foreign matter was detected. The mere presence of particles does not imply that the particles in the medicines were of extraneous substance and not of the requisite contents thereof. The subject drug was manufactured in the month of January, 2011 with expiry in the month of December, 2013. A copy of the subject analytical report was received by the complainant on 31.5.2011. The complainant vide letter, dated 6.6.2011 informed A1 company that the subject drug has been declared to be not of standard quality and called for certain documents and information. In response, A1 company vide letter, dated 4.7.2011, challenged the test report and once again carried out the necessary tests on the sample portion available with it, as the sample portion supplied by the complainant was damaged and was in leaking condition. By sending the reply, dated 4.7.2011, A1 company had appropriately challenged the subject rest reported dated 26.5.2011. However, the complainant, for the reasons best known to him did not send the subject drug for retesting to the Central Drugs Laboratory as mandatorily required under Section 25(3) of the Act. 5. Though all the above grounds were mentioned in the grounds of the petition, at the time of arguments, the Counsel for the petitioners stressed only on the aspect of the failure of the complainant to send the second sample for analysis within the prescribed period, before the expiry date of the drug and hence, the valuable right given to the petitioners under Section 25(3) of the Act stands defeated. In order to appreciate the said argument, we need to have a glance at Section 25(3) of the Act, which is extracted hereunder for ready reference: "(3) Any document purporting to be a report signed by a Government Analyst under this Chapter 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 and other particulars have been disclosed under Section 18-A 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." 6. It is clear from the above provision that within 28 days of the receipt of the copy of the report, the person receiving the copy should intimate that he intends to adduce evidence in controversion of the report. It would be beneficial to read through clause (4) also which runs as under: "(4) Unless the sample has already been tested or analysed in the Central Drugs Laboratory, where a person has under sub-section (3) notified his intention of adducing evidence in controversion of a Government Analyst's report, the Court may, of its own motion or in its discretion at the request either of the complainant or the accused; cause the sample of the drug or cosmetic produced before the Magistrate under sub-section (4) of Section 23 to be sent for test or analysis to the said Laboratory, which shall make the test or analysis and report in writing signed by or under the authority of, the Director of the Central Drugs Laboratory the result thereof, and such report shall be conclusive evidence of the facts stated therein." 7. By reading clause (4) of Section 25, what this Court can understand is that the pre-condition for sending the sample for second analysis is what is said under clause (3) of Section 25, which is that the person receiving the copy of the report has to notify in writing to the Inspector or the Court, that he intends to adduce evidence in controversion of the report. In this case, after receiving the report copy, the petitioners have sent and intimation to the complainant, which is dated 9.7.2011. In this case, after receiving the report copy, the petitioners have sent and intimation to the complainant, which is dated 9.7.2011. A reading of the copy of the said letter filed before this Court shows that the petitioners have only explained the reason for the contamination, which resulted in the report coming out with the finding that the sample is contaminated, stating that it might be only due to invisible damage to bottles in transit or storage. It does not anywhere question the analyst report, either with regard to the genuineness or with regard to the correctness. When there is no attack made on the report on the said aspects, the report stands to be conclusive. As specified in Section 25(3) of the Act, no intention to adduce evidence in controversion of the report can be gathered from a letter, which explains only the reason for the report coming out in the negative. The letter, unless it specifies, either impliedly or expressly, that the petitioners intend to adduce evidence in controversion of the report, cannot be construed as a notification made in compliance of Section 25(3), that he intends to adduce evidence in controversion of the report. When no such intention can be gathered by the Court, the obligation laid on the Court to send the sample on its own or at the request of the complainant or the accused, for second sampling, does not come into operation. 8. The ruling relied upon by the petitioners' Counsel reported in Northern Mineral Limited v. Union of India and another, 2010 (2) ALD (Crl.) 944 (SC) : (2010) 7 SCC 726 , at Paragraph 20 held as under: "20. In the face of the language employed in Section 24(4) of the Act, the act of the accused notifying in writing its intention to adduce evidence in controversion of the report in our opinion shall give right to the accused and would be sufficient to clothe the Magistrate with the jurisdiction to send the sample to the Central Insecticides Laboratory for analysis and it is not required to state that it intends to get the sample analysed from the Central Insecticides Laboratory. True it is that report of the Insecticide Analyst can be challenged on various grounds but the accused cannot be compelled to disclose those grounds and expose his defence and he is required only to notify in writing his intention to adduce evidence in controversion. The moment it is done, the conclusive evidentiary value of the report gets denuded and the statutory right to get the sample tested and analysed by the Central Insecticides Laboratory gets fructified." 9. There is no quarrel with the said finding. The petitioners cannot be compelled to disclose the grounds on which they seek to controvert the report, but in the considered opinion of this Court the letter should be as explicit as to give an understanding to the Court that he intends to adduce evidence in controversion of the said report. In this case no such intention can be gathered from the letter addressed by the petitioners to the Director General, Drugs Control Administration, Hyderabad, for the reasons already mentioned in the afore-discussed paragraphs. 10. Hence, in view of the above, this Court is of the considered opinion that on the ground that the second sampling was not done, the proceedings against the petitioners cannot be quashed. 11. With the above observations, the criminal petition is dismissed. Interim stay granted by this Court, dated 8.3.2019, shall stand vacated. 12. As a sequel, the miscellaneous applications pending, if any, shall stand closed.