'Heart Lung Pack' Wasn't Statutorily Notified As Drug In 2010: P&H High Court Quashes Criminal Case Against Manufacturer
The Punjab and Haryana High Court has quashed a criminal complaint filed against a medical device manufacturer and its directors for allegedly manufacturing "Heart Lung Pack", a cardiac surgery tubing system, without a drug manufacturing licence.The Court held that the product was never specifically notified as a "drug" under Section 3(b)(iv) of the Drugs and Cosmetics Act, 1940 at the time...
The Punjab and Haryana High Court has quashed a criminal complaint filed against a medical device manufacturer and its directors for allegedly manufacturing "Heart Lung Pack", a cardiac surgery tubing system, without a drug manufacturing licence.
The Court held that the product was never specifically notified as a "drug" under Section 3(b)(iv) of the Drugs and Cosmetics Act, 1940 at the time of the alleged offence, and that subsequent administrative clarifications could not retrospectively supply this statutory requirement.
Justice Manisha Batra said, "In the present case, the prosecution relies upon the notification dated 06.10.2005 issued by the Central Government. A perusal of the said notification shows that various medical devices were specified therein, including “Catheters”. However, Heart Lung Pack is not specifically mentioned in the said notification. The case of the petitioners, as emerging from the material on record, is also that Heart Lung Pack is an extracorporeal circuit/customized tubing pack which is used for carrying solutions during surgery and is not itself inserted into the body, whereas a catheter is a distinct device which is inserted into the body. The petitioners have accordingly sought to distinguish Heart Lung Pack from the category of “Catheters”."
This distinction assumes importance because the prosecution cannot proceed merely on the basis that Heart Lung Pack is a medical device. What has to be shown is that the particular device was covered by the statutory notification so as to fall within Section 3(b)(iv) of the Act, 1940 at the relevant time. The requirement of a notification in the Official Gazette is, therefore, not a mere procedural formality, but is the statutory basis for bringing a particular device within the definition of “drug”.
The Court further observed that regulatory requirements could not be created merely through an administrative order or office instruction in the absence of statutory authority. The respondents, however, rely upon the clarification dated 20.03.2009 issued by the CDSCO, wherein Heart Lung Pack finds mention at serial No.15 amongst the nineteen sterile medical devices.
The Court explained, the said document may certainly indicate the stand taken by the department regarding the regulatory treatment of such devices. However, the said clarification is admittedly not a notification issued in the Official Gazette by the Central Government under Section 3(b)(iv) of the Act, 1940. The distinction between a statutory notification and an administrative clarification cannot be lost sight of when the consequence sought to be imposed is criminal in nature.
The complaint was filed by the Drugs Control Officer, Jhajjar, following an inspection on 28.10.2010 of the petitioner company's premises, where manufacturing of Heart Lung Pack was found ongoing without a valid drug manufacturing licence. Samples were taken during that inspection and a subsequent one on 18.04.2012, and after obtaining sanction from the State Drugs Controller, a complaint was filed under Sections 18(c), 27(b)(ii), 28A, 28B and 27(d) of the Act along with relevant Rules.
The trial court summoned the petitioners on 16.07.2013, and a revision against the summoning order was dismissed by the Sessions Judge, Jhajjar on 29.10.2014.
Counsel for the petitioners argued that Heart Lung Pack was never specifically notified as a "drug" under Section 3(b)(iv), which requires the Central Government to specify a medical device by notification in the Official Gazette after consultation with the Drugs Technical Advisory Board. It was submitted that the 06.10.2005 notification listed ten categories of devices, including "Catheters" but not Heart Lung Pack, which is a customised extracorporeal tubing circuit carrying solutions during cardiac surgery and is not itself inserted into the body, unlike a catheter.
While a 20.03.2009 CDSCO clarification listed Heart Lung Pack among 19 devices "covered" under the Act, this clarification carried no statutory force, and was itself followed by a 05.05.2009 circular stating the matter had been referred to the Ministry of Health for approval, with pre-existing practice to continue meanwhile. A subsequent CDSCO letter dated 07.09.2012 — asserting Heart Lung Packs fell under "Catheter/Disposable Perfusion Set" — postdated the alleged 2010 offence and was merely an administrative communication, not a Gazette notification.
Counsel also pointed to a 20.05.2015 communication from the Director General of Health Services recording an Expert Committee's opinion that "Heart Lung Pack is not a drug but it is a medical device."
The State opposed quashing, arguing that Heart Lung Pack fell within the notified "Catheter" category per the 2005 notification, that this was reinforced by the 2009 clarification and 2012 letter, and that whether the product technically qualified as a catheter/perfusion set was a technical/evidentiary question not suited for determination under Section 482 Cr.P.C.
The Court framed the central question as whether, on the date of alleged manufacture (28.10.2010), Heart Lung Pack could legally be treated as a "drug" under Section 3(b)(iv) — holding that mere medical use of a device does not by itself bring it within the definition; specification by Gazette notification is the statutory basis, not a procedural formality.
Examining each document relied upon by the prosecution, the Court found, "The 2005 notification did not specifically mention Heart Lung Pack, and the petitioners had specifically distinguished it from catheters as a device not inserted into the body — relying on the Himachal Pradesh High Court's ruling in Biogenetic Drugs (P) Ltd. v. State of Himachal Pradesh, 2025:HHC:20463, that regulatory requirements cannot be created through administrative orders absent statutory notification."
The 20.03.2009 clarification was "admittedly not a notification issued in the Official Gazette," and its own follow-up circular dated 05.05.2009 confirmed the matter was still pending Ministry approval, undermining any claim that it represented a settled statutory position.
The 07.09.2012 letter, even if it equated Heart Lung Pack with notified categories, was issued nearly two years after the alleged manufacture and was, in any case, only "an administrative communication and not a notification in the Official Gazette."
Relying on the Bombay High Court's ruling in Kirti Kumar Jayantilal Patel v. State of Maharashtra, the Court held that a manufacturer cannot be prosecuted for non-compliance with a standard not prescribed at the time of manufacture, and quashed similar proceedings on that principle. Invoking the rule of strict construction of penal statutes from Tolaram Relumal v. State of Bombay, AIR 1954 SC 496, the Court held that penal consequences cannot be imposed unless the statutory requirement is clearly and unambiguously satisfied.
The Court concluded, "The subsequent administrative communications, including the letter dated 07.09.2012, cannot retrospectively supply the requirement of a statutory notification so as to sustain criminal liability for the alleged manufacture in the year 2010."
The Court clarified it was not deciding the general regulatory status of Heart Lung Pack as a medical device, but only that the foundational statutory requirement for treating it as a "drug" at the relevant time was absent — and held that since the prosecution's entire case rested on this foundational premise, continuation of proceedings without it would amount to an abuse of process warranting interference under Section 482 Cr.P.C., even without undertaking a "mini-trial," since the relevant documents were themselves on record.
Allowing the petition, the Court quashed the complaint dated 16.07.2013, the summoning order dated 16.07.2013, and the order dated 29.10.2014 dismissing the revision, along with all consequential proceedings.
Mr. Sushant Mahapatra, Advocate and Mr. Sanjeev Kumar, Advocate for the petitioners.
Mr. Ashok Kumar Khubbar, Addl. A.G., Haryana.
Case Title: M/s Super Cardio Devices Private Limited and others v. State of Haryana