Karnataka HC Directs Strict Adherence to 60-Day Drug Testing Timeline & Calls for Real-Time Online System to Monitor Testing & Reporting

The Karnataka High Court has emphasized the need for adherence to the statutory timelines for drug testing.

Specifically, the Drugs Controller General (India) has been directed to ensure that Government Analysts complete drug tests and submit reports within the prescribed 60-day period.

To address delays, the Court recommended the creation of an efficient online system to track the testing and reporting process in real-time. This system should allow for immediate access to test results and help prevent the circulation of potentially harmful drugs, the court said.

In that context, the Bench of Justice NS Sanjay Gowda observed that, "The Drugs Controller General (India) is also directed to ensure that an efficient online system is created, whereby the drug samples which are sent for test/analysis are expeditiously tested and analyzed by the Government Analyst within sixty days, and the reports sent by them are available online on a real-time basis. This creation of an effective mechanism to ensure that the entire process is monitored, and unnecessary delay is not caused in the conduct of the test/analysis of the drugs sample sent for test to the Government Analysts would ensure that the illeffects of a drug of doubtful quality is prevented. The Drugs Controller (General) shall preferably ensure that this entire process be web-hosted so that that all the concerned are aware of the process of testing and its outcome."

In this case, a company, along with its Chairman, Managing Director, and Executive Director, faced legal proceedings for allegedly distributing drugs that were 'not of standard quality.' The company argued that the complaint did not contain any specific accusations against them. They also contended that the tests on the drugs were conducted after the drugs’ shelf life had expired, which would affect the accuracy of the results. The company claimed that, due to this, the results could not reliably indicate that the drugs were substandard.

On the other hand, the prosecution argued that the test reports clearly showed that the drugs were below standard, and all those involved, including the company and its executives, should be prosecuted accordingly.

The Court addressed critical procedural errors in a complaint under the Drugs and Cosmetics Act involving allegations of substandard drug manufacturing. The complaint accused a company and its key officials, including the Chairman, Managing Director, and Executive Director, along with manufacturing and analytical chemists, of responsibility for the substandard drugs. However, the complaint failed to specify the exact roles and responsibilities of each accused individual, particularly the higher management, thus not meeting the Supreme Court’s requirements for detailed allegations as outlined in Brij Lal Mittal and Lalankumar Singh.

The Court emphasized that a complaint must detail each accused’s involvement in the alleged wrongdoing, regardless of whether the complaint is filed by a public servant or a private individual.

The Drugs Inspector’s argument that statutory investigations should bypass these detailed requirements was rejected. The Court clarified that under Chapter XV of the CrPC, all complaints, including those by public servants, must meet the same standards for specificity. The court ultimately held that the complaint’s general allegations were insufficient, rendering the prosecution unsustainable.

The proceedings against the accused were thus quashed, and the court directed improvements in procedural handling and timely reporting by the Drugs Inspector and Government Analysts to avoid similar issues in the future.

The Court also issued several directions to improve the procedural handling of drug quality complaints and ensure timely and accurate testing. This included instructions that the Drugs Inspector must secure information about the drug manufacturer simultaneously with sending the drug sample for analysis. This ensures that when the Government Analyst’s report is received, the manufacturer’s details are already available to facilitate prompt communication of the results.

The Court ordered a compliance report to be submitted within eight weeks. 

Cause Title: M/s Zim Laboratories Ltd. & Ors. vs Union of India (Neutral Citation: 2024:KHC:35389)

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