Jammu: The High Court of J&K and Ladakh has quashed criminal proceedings against Maxmed Life Sciences Pvt. Ltd. and its director in a case concerning a drug sample declared “not of standard quality”, holding that the company had been deprived of its statutory right to have the disputed sample re-analysed.
Justice Wasim Sadiq Nargal, in a judgment allowed a petition filed by Maxmed Life Sciences Pvt Ltd of Uttarakhand and its director, Sanjeev Wasan. The bench quashed the complaint and all consequential proceedings against the petitioners.
The case arose from a sample of the drug “Amzone”, Batch No. MLI-386, manufactured by the company in December 2013.
The sample was lifted on January 16, 2014, from the premises of Chest Diseases Hospital, Bakshi Nagar, Jammu. The drug had an expiry date of November 2015.
The Government Analyst, Jammu, in a report dated February 11, 2014, declared the sample “Not of Standard Quality”, stating that it had failed the test for particulate matter.
The Drug Inspector subsequently issued a statutory notice to the petitioner-company informing it about the analyst’s report.
According to the judgment, the company immediately disputed the report and communicated its intention to adduce evidence in controversion and sought re-analysis of the sample.
The High Court noted that this communication was made within the statutory period of 28 days prescribed under Section 25(3) of the Drugs and Cosmetics Act, 1940.
The authorities contended that the company had referred to re-testing by an NABL-accredited laboratory and, on that basis, had forfeited its right to have the sample examined by the Central Drugs Laboratory.
The High Court rejected that contention. It held that merely referring to an NABL-accredited laboratory could not be treated as abandonment or waiver of the statutory right.
Once the petitioners had communicated their intention to controvert the Government Analyst’s report within the prescribed period, the statutory mechanism under Section 25(4) became available.
The court also took note of a communication dated May 19, 2014, through which the competent authority had permitted re-analysis/re-testing under Section 25(4).
However, the sample was not sent to the Central Drugs Laboratory before its shelf life expired.
By the time the petitioners received summons in November 2016, the drug had already expired in November 2015. The court observed that meaningful re-analysis was consequently no longer possible.
It held that the subsequent expiry of the sample could not prejudice the petitioners after they had timely exercised their statutory right to dispute the analyst’s report.
The court concluded that failure to preserve an effective opportunity for re-analysis caused substantive prejudice to the petitioners and rendered the statutory safeguards under Sections 25(3) and 25(4) ineffective.
Accordingly, the High Court allowed the petition, dismissed the impugned complaint insofar as the petitioners were concerned, and quashed all consequential proceedings.
