SC Quashes Substandard Rabeprazole Case Against Indica Labs, Cites Limitation Bar

A Bench of Justice Vikram Nath and Justice Sandeep Mehta allowed the appeals filed by Miteshbhai J. Patel and another, challenging the Kerala High Court’s judgment dated December 5, 2023, which had upheld the Trial Court’s decision to continue proceedings against them.

On 29 January 2010, the Drug Inspector collected samples of Rabeprazole tablets from City Medicals in Kozhikode. The drug, manufactured by Indica Laboratories Pvt. Ltd., was tested in a government laboratory, and reports dated 30 March 2010 and 9 April 2010 declared it “not of standard quality” for failing the tests of Related Substances and Assay.

Based on these reports, two complaints (CC 1/2014 and CC 2/2014) were filed against the company’s directors under Section 32 of the Drugs and Cosmetics Act, 1940, alleging violations of Section 18(a)(i), punishable under Section 27(d).

The appellants challenged these complaints, arguing that they were filed beyond the three-year limitation period prescribed under Section 468(2)(c) CrPC.

In 2018, the Trial Court rejected their plea, holding that the delay was justified as time was required to issue prosecution notices and collect details of the accused.

The Kerala High Court, in December 2023, upheld this reasoning. However, the Supreme Court disagreed, holding that the limitation period began from the dates of the drug analyst’s reports, 30 March 2010 and 9 April 2010, and since the complaints were filed only on 24 June 2013 and 3 July 2013, they were beyond the statutory three-year period.

Consequently, the court observed;

"Section 468(2) of the Code of Criminal Procedure prescribes the period of limitation and states that for any offense that is punishable with a term exceeding one year but not exceeding three years, the period of limitation shall be three years. The punishment prescribed under Section 27 of the 1940 Act for the offense of manufacturing or distributing substandard drugs is three years. Therefore, any complaint disclosing such an offense ought to have been made within a period of three years. Section 469(a) of the CrPC provides that the period of limitation in relation to an oCence commences on the date of the offense.

The Court further noted that the company’s particulars were already available in the Government Analyst’s reports and even communicated to the company in 2010, leaving no justification for the delay.

"In the present case, it is not disputed that the complaints were filed much later than three years from the date of the reports submitted by the drug analyst. As is the nature of this case, an offense would be made out only after the report of the drug analyst is received.

As the drug analyst reports in the present case were received on 30.03.2010 and 09.04.2010, therefore, the limitation period by virtue of Section 469(a) of CrPC shall commence from that respective date when the said reports were received. The complaint is filed by the respondents only on 24.06.2013 and 03.07.2013, which is beyond the statutory time limit."

It also observed that neither the Trial Court nor the High Court could have condoned the delay when no such request was made.

Referring to the principle “vigilantibus non dormientibus jura subveniunt” (law helps the vigilant, not the indolent), the Supreme Court concluded that the prosecution had sufficient time to act but failed to do so.

The Court ruled that the proceedings were barred by limitation and quashed the complaints, noting,

"In view of the above discussion, we are of the firm view that the impugned proceedings were barred by limitation and thus deserve to be quashed."

"Although other grounds such as not conducting a mandatory enquiry as per Section 202 CrPC were raised, we are not inclined to deal with them since the ground of limitation is good enough to allow the appeal."

"Accordingly, the appeals stand allowed. The impugned judgment of the High Court is set aside and the proceedings arising from the complaint are quashed."

To view the official order, click the link below: