Court Finds No Statutory Basis to Classify Heart Lung Pack as "Drug," Quashes Complaint and Summoning Orders
In a significant judgment, the Punjab and Haryana High Court has quashed the criminal proceedings against M/s Super Cardio Devices Pvt. Ltd. and its directors, who were accused of manufacturing a Heart Lung Pack without a drug manufacturing license. The case, which revolved around the classification of the Heart Lung Pack as a "drug" under the Drugs and Cosmetics Act, 1940, was dismissed by the High Court due to the lack of a statutory notification categorizing the device as such.
The judgment, delivered by Justice Manisha Batra, highlights the importance of statutory notifications in classifying medical devices as drugs. The Court emphasized that a medical device cannot be considered a drug under Section 3(b)(iv) of the Drugs and Cosmetics Act, 1940 unless it is specifically notified by the Central Government in the Official Gazette. In this case, the Heart Lung Pack was not mentioned in the relevant notifications, including the one issued on October 6, 2005, which listed ten categories of medical devices but did not include the Heart Lung Pack.
The prosecution had relied on a clarification dated March 20, 2009, which listed the Heart Lung Pack among devices covered under the Drugs and Cosmetics Act. However, the Court found that this clarification did not have the force of a statutory notification. Furthermore, a circular dated May 5, 2009, indicated that further orders were awaited from the Ministry of Health, reinforcing the argument that the classification was not settled.
The Court also referred to a subsequent letter from September 7, 2012, which attempted to include the Heart Lung Pack under the categories of Catheter/Disposable Perfusion Set. However, this letter was deemed an administrative communication and not a statutory notification capable of retrospectively imposing criminal liability.
Citing previous judgments, including those from the Himachal Pradesh and Bombay High Courts, the Court underscored the principle that criminal liability cannot be imposed based on non-statutory clarifications or retrospective administrative communications. It reiterated the necessity of having a clear statutory basis before proceeding with criminal charges.
Consequently, the High Court concluded that continuing the criminal proceedings would constitute an abuse of the legal process, given the absence of a clear statutory foundation for treating the Heart Lung Pack as a drug at the time of its manufacture in 2010. The Court's decision to quash the complaint, summoning orders, and all related proceedings marks a crucial stance on the interpretation and application of statutory notifications in regulatory matters.
Bottom Line:
Drugs and Cosmetics Act, 1940 Section 3(b)(iv) A medical device cannot be treated as a "drug" unless it is specified by the Central Government through notification in the Official Gazette; administrative clarifications or communications cannot substitute the statutory requirement of notification.
Statutory provision(s): Drugs and Cosmetics Act, 1940 Section 3(b)(iv), Criminal Procedure Code, 1973 Section 482.
