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High Court Quashes Case Against Super Cardio Devices as Heart Lung Pack Not Notified Drug
In a significant ruling that underscores the over , the has a against M/s Super Cardio Devices Private Limited and its directors for allegedly manufacturing "Heart Lung Pack" without a . Justice Manisha Batra held that the product was never specifically notified as a "drug" under at the time of the alleged offence in .
The Case: A Product Caught in Regulatory Limbo
The trouble began when the Drugs Control Officer, Jhajjar, received information that Super Cardio Devices was manufacturing Heart Lung Pack—a customized tubing system used in cardiac surgery—without a valid . An inspection on revealed ongoing production, and samples were seized. A subsequent inspection in led to a complaint filed under , along with relevant Rules. The trial court summoned the petitioners on , and a against that order was dismissed by the on .
Arguments: vs. Administrative Circulars
Counsel for the petitioners, and , argued that the entire prosecution was built on a false premise: that Heart Lung Pack is a "drug" under the Act. Section 3(b)(iv) requires the to specify a medical device by after consulting the . The notification listed ten categories of devices—including "Catheters"—but did not mention Heart Lung Pack. They emphasized that the Heart Lung Pack is an extracorporeal circuit that carries solutions during surgery and is not inserted into the body, unlike a catheter.
The prosecution, represented by Additional Advocate General , relied on a clarification that listed Heart Lung Pack among 19 devices "covered" under the Act, and a letter stating that Heart Lung Packs fall within the "Catheter/Disposable Perfusion Set" category. The State argued that the product's technical classification was a matter of evidence not suitable for determination under .
Court's Analysis: Gazette Notification Cannot Be Bypassed
Justice Batra examined each document relied upon by the prosecution and found them wanting. The
notification did not specify Heart Lung Pack. The
clarification, while mentioning the product, was
"admittedly not a notification issued in the Official Gazette"
and its own follow-up circular in May
confirmed that the matter was still pending Ministry approval. The
letter was issued nearly two years after the alleged offence and was merely an
, not a
.
The Court drew on the 's ruling in Biogenetic Drugs (P) Ltd. v. State of Himachal Pradesh (), which held that cannot be created through in the absence of . It also cited , where the proceedings because the manufacturer could not be faulted for non-compliance with a standard not prescribed at the time of manufacture. Invoking the principle of from Tolaram Relumal v. State of Bombay (AIR SC 496), the Court observed that cannot be imposed unless the is clearly satisfied.
Key Observations from the Judgment
"The requirement of a is, therefore, not a mere procedural formality, but is the for bringing a particular device within the definition of 'drug'."
"The distinction between a and an administrative clarification cannot be lost sight of when the consequence sought to be imposed is criminal in nature."
"The subsequent administrative communications, including the letter dated 07.09. , cannot the requirement of a so as to sustain for the alleged manufacture in the year ."
"In these circumstances, permitting the to continue against the petitioners would amount to permitting a prosecution without the necessary to attract the of the Act, 1940."
The Verdict:
Allowing the petition, the Court Complaint No. 1231 dated , the , and the order dismissing the , along with all consequential proceedings. Justice Batra clarified that the ruling does not address the general regulatory status of Heart Lung Pack as a medical device, but only holds that the foundational for treating it as a "drug" at the relevant time was absent. The decision serves as a reminder that under specialized statutes must be founded on clear , not on .
