Lalitha Kanneganti, J.
1. Challenging the order dated 21.11.2020 in Crl.M.P. No. 1215 of 2020 passed by the IV Additional Chief Metropolitan Magistrate, Visakhapatnam, this criminal revision case has been filed.
2. The 1st respondent herein filed an application under Section 25 (4) r/w 23 (4) (ii) of the Drugs and Cosmetics Act, 1940 (for short "DC Act") for sending the second portion of the sample for re-test/analysis. The Court below allowed the said application.
3. The case of the petitioner is that it is a registered company engaged in manufacture and sale of various pharmaceutical products and earned good reputation for a period of more than two decades. On 23.09.2019 the Drug Inspector has collected three samples of "Biphasic Isophane Insulin Injection IP". As per the procedure, one sample was forwarded to the Government Analyst, Central Drugs Laboratory (National Institute of Biologics), Noida on 23.09.2019 and the Drugs Inspector received the analysis report stating that the drug is not of standard quality, as the sample does not conform to soluble insulin human content as per IP 2018. Thereafter the petitioner herein was delivered with third portion of sealed samples along with original test reports and asked to furnish explanation/comments in respect of subject drug. The petitioner herein gave a reply disagreeing with the Government analyst report and intending to adduce evidence. Basing on which, the respondents herein filed Crl.M.P. No. 1215 of 2020 before the Court below to order to send the second portion of sample for re-test/analysis. The Court below after conducting enquiry, has allowed the application. Aggrieved by the same, the petitioner has approached this Court.
4. Heard Sri S.V.S.S. Sivaram, learned counsel for the petitioner and the learned Assistant Solicitor General appearing on behalf of the respondent-State.
5. Learned counsel for the petitioner submits that the petitioner while disagreeing with the Government analyst report stated that they have got the analyst report of the same batch during October, 2019 from NIB, Noida. He submits that when the sample drawn from the same batch was already analyzed by the same institution at Noida, which gave its report stating that it is confirming the standard quality, the application filed under Section 25 (4) of DC Act is barred under law. He further submits that there is total silence on the part of the respondents as to the mode and manner of sample collection and its storage at the requisite temperature which is 2 to 8 degrees. He submits that the samples being temperature sensitive, shall have to be stored at particular temperatures, thereby the cold chains shall be maintained in its entire life cycle of the samples and if the chain is broken, the results would vary. He submits that the respondent did not produce any evidence before the Court below that the samples collected were stored at required temperature.
6. Learned counsel for the petitioner submits that it is also not the case of the respondent before the Court below that any standard operation procedures were followed or any inspection report was furnished during the proceedings before the Court stating the mode and manner in which the inspection, sample collection and storage were done. He further submits that the respondent filed the application before the Court below with inordinate delay seeking to send the third sample i.e. 2nd portion for analysis, without producing any evidence as to the storage of such samples as mandated under the 'India Pharma Copia'.
7. Learned counsel for the petitioner finally submits that the Court below erred in holding that sending of sample for re-test/analysis does not cause any prejudice to the petitioner herein, because the petition itself was filed with inordinate delay and further serious prejudice would be caused to the petitioner if a re-test of a sample which is not properly stored is done, inasmuch as such a report will be the basis for further action under the DC Act. Therefore, he urges the Court to set aside the impugned order.
8. Per contra, learned Assistant Solicitor General would submit that the Court below after considering the contentions on behalf of both sides has passed a reasoned order and the petitioner could not make out any ground to interfere with the impugned order. He submits that the respondent filed the application before the Court below, only then the petitioner herein by way of his reply disagreed with the analyst report and expressed his intention to adduce evidence in contravention of the report. Therefore, there is absolutely no bar under law for filing the application under the provisions of DC Act.
9. Having heard the learned counsel on either side, the issue that falls for consideration is, whether the impugned order warrants any interference from this Court.
10. The undisputed facts of the case are that consequent upon collecting three samples of "Biphasic Isophane Insulin Injection IP", one sample was sent to the Government analyst at NIB, Noida, who issued a report stating that drug is not of standard quality, as the sample does not conform to soluble insulin human content as per IP 2018. Thereafter the petitioner herein issued a reply disagreeing with the analysis report and expressed his intention to adduce evidence in contravention of the report.
11. The Court below has observed that though the petitioner herein expressed his intention to adduce evidence in contravention of analyst report, he is opposing to send the second portion of sample for re-test/analysis. The Court below has rightly observed that when there is contradiction between the report issued by the same laboratory, it is appropriate to send the sample for analysis. Therefore, this Court is of the considered opinion that the order impugned does not warrant any interference from this Court. However, with regard to the contention of the learned counsel for the petitioner about the mode of storage of the sample at the required temperature, this Court feels it appropriate to direct the Government analyst to obtain necessary data before analyzing the second sample with regard to its mode of storage, whether it is stored within the required temperature or not and whether it is fit for analysis or not.
12. Accordingly, the criminal revision case is disposed of. No order as to costs.
As a sequel, all the pending miscellaneous applications are closed.
Comments