JAMMU AND KASHMIR HIGH COURT BENCH AT SRINAGAR
Sanjay Dhar, J.
Swiss Garnier Life Sciences & Ors. – Appellants
Versus
Union of India – Respondent
CRMC No. 169 of 2016
Decided On : 01-11-2022
Drugs and Cosmetics Act - Complaint against Drug Manufacturers - Section 18(a)(i) read with Section 27(d) - Section 25(4) - Section 25(3) - Section 25(1) - Section 23 - Section 4 of the Evidence Act - Right of Manufacturer to Adduce Evidence - Conclusiveness of Report - Re-analysis of Sample
Fact of the Case:
The petitioners challenged a complaint filed by the respondent Drugs Inspector alleging offences under Section 18(a)(i) read with Section 27(d) of the Drugs and Cosmetics Act, 1940. The drug sample was initially found to be of standard quality by the Government Analyst, but upon re-analysis by the Central Drugs Laboratory, it was found to be not of standard quality. The petitioners contended that their statutory right to controvert the report of the Government Analyst was violated, and the variation in the drug content was not significant enough to warrant prosecution.
Finding of the Court:
The court found that the petitioners' right to adduce evidence in controversion of the report of the Government Analyst was not violated, as the sample had already been tested by the Central Drugs Laboratory. The court also held that the variation in the drug content was a matter for trial and could not be determined in the present proceedings. The petition was dismissed, and the trial court record was to be sent back to the trial court.
Issues: Violation of Manufacturer's Statutory Right - Significance of Drug Content Variation - Conclusiveness of Report
Ratio Decidendi: The right of a manufacturer to adduce evidence in controversion of the report of the Government Analyst is not violated if the sample has already been tested by the Central Drugs Laboratory. The variation in drug content is a matter for trial and cannot be determined in preliminary proceedings. The report of the Central Drugs Laboratory is not conclusive against the petitioners, and they have the right to controvert it in the trial court.
Final Decision: The petition was dismissed, and the trial court record was to be sent back to the trial court for further proceedings.
JUDGMENT
1. The petitioners have challenged the complaint filed by respondent Drugs Inspector against them and the co-accused before the Court of Chief Judicial Magistrate, Srinagar, alleging commission of offences under Section 18(a)(i) read with Section 27(d) of the Drugs and Cosmetics Act, 1940.
2. It appears that on 26.04.2013, sample of a drug, namely, Zargo50 (Losartan Potassium Tab IP) Batch No.BPSG12198, manufacturing date 10/2012, expiry date 9/2014, manufactured by petitioner No.1, was lifted from the premises of co-accused EFF AAY Traders Pharmaceutical Distributors House No.131, Nursingh Garh, Srinagar, by the respondent Drugs Inspector. One portion of the sealed sample of the drug was sent to the Government Analyst i.e., Regional Drugs Testing Laboratory, Sector 39-C, Chandigarh, and vide report dated 26.06.2013, it was reported that the drug in question is of standard quality.
3. Vide order dated 10.09.2013, passed by a Division Bench of this Court in PILNo.6/2013 titled Dr. Nisar ul Hassan and another vs. State of J&K and Ors., general directions were issued that the samples collected by Drug Inspectors be sent to more than one laboratories for testing so as to dispel any impression of error or any other extraneous consideration. Accordingly, the respondent Drugs Inspector sent sample of the drug in question to Central Drugs Laboratory, Kolkata, for re-analysis through the court of Judicial Magistrate, 1st Class, Jammu. As per the test report issued by Central Drugs Laboratory, Kolkata, on 28.02.2014, the sample in question was found to be of not a standard quality. Accordingly, the prosecution was launched against the petitioners who happen to be the manufacturers of the drug in question and the co-accused by filing a complaint before the Court of Chief Judicial Magistrate, Jammu, which later on came to be presented before the Court of Chief Judicial Magistrate, Srinagar.
4. The petitioners have challenged the impugned complaint and the order passed by the learned Chief Judicial Magistrate, Srinagar, whereby process has been issued against them, on the grounds that the manufacturer has a statutory right to controvert the report of the Government Analyst by adducing evidence but in this case said right of the petitioners has been violated. It has been contended that the respondent Drugs Inspector has not issued any notice to the petitioners under Section 23 and 25 of the Drugs and Cosmetics Act nor a portion of the sample was sent to the petitioners. It has been contended that the impugned complaint has been filed by the respondent Drugs Inspector at a time when there was no time left for the date of expiry of the drug in question and, as such, the petitioners had no opportunity of applying to the Court with a request for re-analysis of the sample. According to the petitioners, on this ground alone the prosecution is liable to be quashed in terms of the law settled by the Supreme Court on the issue. It has been contended that under the garb of the orders of the High Court, the statutory protection given to a manufacturer cannot be taken away. It is also contended that even otherwise the variation in the content of the drug in question is not of a significant nature as would make the drug spurious and, as such, it was not open to the respondent Drugs Inspector to launch prosecution against the petitioners.
5. I have heard learned counsel for the parties and perused the material on record including the trial court record.
6. There can be no dispute to the fact that that manufacturer of a drug has a statutory right to adduce evidence in controversion of the report of the Government Analyst and he has to exercise this right within 28 days of receipt of copy of the report. Once this intension is notified by the manufacturer, the sample of the drug produced before the Magistrate has to be sent for testing or analysis to the Central Drugs Laboratory. There is no dispute to the legal position that if violation of this right h
The right of a manufacturer to adduce evidence in controversion of the report of the Government Analyst is not violated if the sample has already been tested by the Central Drugs Laboratory.
The judgment establishes that the failure of the prosecution to adhere to statutory requirements, particularly regarding the right to contest the Government Analyst's report, can lead to the quashing....
Seizure of sub-standard quality of drug – When report of Government Analyst itself is shrouded in serious suspicion and it is not sure as to whether report of Government Analyst relates to sample lif....
The main legal point established in the judgment is that the rights of the accused under sections 25(3) and 25(4) of the Drugs and Cosmetics Act, 1940 must be upheld, and any violation of these right....
The prosecution of drug quality violations is unsustainable when testing delays invalidate the accused's rights to challenge the results, highlighting the need for timely compliance under the Drugs a....
The main legal point established in the judgment is the conclusive nature of the State Analyst Report and the requirement to exercise the statutory right to request re-analysis by the Central Drugs L....
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