Karnataka High Court Directs Creation Of Online System For Expeditious Testing Of Drug Samples By Govt Analyst, Uploading Of Reports

The Karnataka High Court has directed the Drugs Controller General (India) to ensure that an efficient online system is created, whereby the drug samples which are sent for test/analysis are expeditiously tested and analysed by the Government Analyst within sixty days, and the reports sent by them are available online on a real-time basis.

A single judge bench of Justice N S Sanjay Gowda issued the directions while quashing the prosecution initiated against M/s Zim Laboratories Ltd and its Chairman and Managing Direction and others, under Section 27D of the Act.

To ensure transparency, the court has suggested the Drugs Controller (General) preferably ensure that the entire process be web-hosted so that all the concerned are aware of the process of testing and its outcome.

Further, it has directed Drug Inspectors to ensure that they secure information relating to the person from whom the drug was acquired (as provided under Section 18A of the Act); and the place where the drug was manufactured (as provided under Section 24 of the Act), at the same time that they send the drug sample for test/analysis to the Government Analyst.

The court added that thereafter, on receipt of the report, they are further directed to immediately forward the same to the manufacturer of the drug whose details are provided under Section 18A of the Act.

Noting that under Rule 45 of the 2017 Rules, a time limit of 60 days is prescribed for the conduct of the test and for sending of the report by the Analyst, the court said, “If a Government Analyst takes several months or, as in this case, more than a year to conduct the test/analysis and submit their report, the possibility of the drug continuing in circulation, thereby exposing the public to its ill-effects is clear and present.”

Moreover, it was observed that the Inspector also cannot initiate action against the manufacturer until he has secured the report from the Government Analyst and has furnished a copy of such report to the manufacturer.

Following this it directed the Drugs Controller General (India), CDSCO, New Delhi to issue proper directions to the Government Analysts to ensure that the test/analysis of the drug sample sent to them is conducted without any delay and within the period of sixty days prescribed in Rule 45.

On the merits of the case, the company had argued that no proceedings could have been initiated against petitioner No.1—Company, its Chairman, its Managing Director and its Executive Director when the complaint itself did not contain any specific averments against them. Further, the procedure prescribed under the Act and the rules was flouted and the tests were conducted after the shelflife of the sample drugs had expired and, hence, their results would not indicate that the subject drugs were 'not of standard quality'.

The prosecution opposed the plea saying the test reports obtained clearly indicated that the drugs were 'not of standard quality' and all the petitioners were thus required to be prosecuted.

The bench referred to the provisions of the Act and Rules and then noted that since the report and first samples were sent after the shelf-life of the drug sample had expired, the valuable right that the manufacturer had to dispute the veracity of the test report of the Government Analyst was taken away.

Thus it held “If this statutory right of the manufacturer to oppose the test report by either adducing evidence in contravention of the report or by requesting the Court to send the same for the 2nd and conclusive test to the CDL was taken away, the entire prosecution would be vitiated as the right of the accused to defend itself, as provided under the Act itself, had been taken away. It is thus obvious that the prosecution would only be a futile exercise.”

In regards to the second sample which was seized in 2014, the court noted that a joint investigation was conducted by the Drugs Inspector, CDSCO, West Zone, Mumbai and the Drugs Inspector, FDA, Nagpur on 13.08.2015. The controlled sample available with petitioner No.1 complied with the test for drug release and the received portion of the sample also passed the test at the L2 stage.

Noting that in the instant case, the complaint merely alleged that all the accused were responsible for the manufacture of the subject drug, the court said “The complaint against accused Nos.2 to 4, i.e., the Chairman, Managing Director, and Executive Director should have categorically stated as to how and in what manner they were responsible for the conduct of the business of the Company.”

It added “Admittedly, even according to the complaint, these three persons were not responsible for the manufacturing of the drug and from the post that they were holding, and it cannot be presumed that they were, by themselves, responsible for the conduct of the business of the Company in terms of production of the subject drug. It is thus clear that the complaint lodged against accused Nos.2 to 4 is unsustainable.”

Accordingly, it allowed the petitions and quashed the proceedings against the petitioners.

Appearance: Advocate Desu Reddy G for Petitioners.

Senior CGC Madhukar Deshpande for Respondent.

Citation No: 2024 LiveLaw (Kar) 393

Case Title: M/S ZIM LABORATORIES LTD & Others AND Union of India

Case No: CRIMINAL PETITION NO. 8341 OF 2018

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