Administrative Clarification Cannot Turn a Medical Device into a ‘Drug’ or Retrospectively Create Criminal Liability Without Gazette Notification: Punjab and Haryana High Court Quashes Heart Lung Pack Prosecution
Case Name: M/s Super Cardio Devices Private Limited and Others v. State of Haryana
Date of Judgment: September 14, 2026
Citation: CRM-M No. 11321 of 2015
Bench: Hon’ble Mrs. Justice Manisha Batra
Held: The Punjab and Haryana High Court held that a medical device does not become a “drug” under Section 3(b)(iv) of the Drugs and Cosmetics Act, 1940 merely because it is used for a medical purpose or is subsequently treated as regulated by departmental authorities. For the penal provisions of the Act to apply, the prosecution must establish that the particular device was specified by the Central Government through a notification published in the Official Gazette after consultation with the Drugs Technical Advisory Board.
An administrative clarification, departmental circular or subsequent official communication cannot substitute the statutory requirement of a Gazette notification. Nor can a later departmental understanding be applied retrospectively to create criminal liability for manufacturing undertaken when the product’s statutory classification was neither clearly established nor supported by the prescribed notification.
The Court found that no statutory notification had been produced to show that a Heart Lung Pack was included within the definition of “drug” on October 28, 2010, the date of the alleged manufacture. Since the allegation of manufacturing without a licence depended entirely upon the product first being legally classified as a drug, the absence of that foundational statutory ingredient rendered the prosecution unsustainable.
Summary: M/s Super Cardio Devices Private Limited operated a manufacturing facility at MIE Part-A, Bahadurgarh, District Jhajjar. The second petitioner was described as its Director-cum-Manufacturing Chemist, while the third petitioner was stated to be a Director of the company.
Acting upon information that the company was manufacturing Heart Lung Packs without a valid drug manufacturing licence, the Drugs Control Officer inspected its premises on October 28, 2010. Manufacturing activity relating to Heart Lung Packs was allegedly found underway, and samples were taken. During another inspection conducted on April 18, 2012, three pieces of the product were collected from the finished goods store.
The State treated the Heart Lung Pack as a “drug” and alleged that its manufacture without a licence violated Section 18(c), punishable under Sections 27(b)(ii), 27(d), 28A and 28B of the Drugs and Cosmetics Act, along with the applicable provisions of the Drugs and Cosmetics Rules, 1945. After obtaining permission from the State Drugs Controller, the Drugs Control Officer instituted Complaint No. 1231 on July 16, 2013.
The Chief Judicial Magistrate, Jhajjar, summoned the petitioners on the same date. A revision against the summoning order was dismissed by the Sessions Judge on October 29, 2014. The petitioners consequently approached the High Court under Section 482 CrPC, corresponding to Section 528 of the Bharatiya Nagarik Suraksha Sanhita, 2023, seeking quashing of the complaint, summoning order and consequential proceedings.
The petitioners argued that the entire prosecution rested upon the legally incorrect assumption that a Heart Lung Pack was a “drug” within Section 3(b)(iv). That provision requires the Central Government to specify a medical device through a notification in the Official Gazette before it can be brought within the statutory definition of a drug.
The Central Government’s Gazette notification dated October 6, 2005 specified ten categories of medical devices, including cardiac stents, drug-eluting stents, catheters, intraocular lenses, IV cannulae, bone cement, heart valves, scalp vein sets, orthopaedic implants and internal prosthetic replacements. It did not expressly mention Heart Lung Packs.
The petitioners maintained that a Heart Lung Pack is a customised tubing pack or extracorporeal circuit used to carry solutions during cardiac surgery and is not itself inserted into the human body. It was therefore distinct from a catheter, which is inserted into the body. The State, however, sought to place the product within the notified category of “Catheters” or “Disposable Perfusion Sets.”
The prosecution principally relied upon a clarification dated March 20, 2009 issued by the Central Drugs Standard Control Organisation, which included Heart Lung Packs among 19 medical devices stated to be covered under the Drugs and Cosmetics Act and Rules. The High Court found that this clarification was not a notification issued by the Central Government in the Official Gazette under Section 3(b)(iv).
The legal uncertainty was reinforced by a CDSCO circular dated May 5, 2009. That circular recorded that the March 20 clarification had been referred to the Ministry of Health and Family Welfare for concurrence and approval. Pending a final decision, the regulatory practices prevailing before March 20, 2009 were directed to continue. The Court held that these documents did not reveal a clear and unequivocal statutory inclusion of Heart Lung Packs under the Act during the relevant period.
The State also relied upon a communication dated September 7, 2012 stating that Heart Lung Packs were covered under the categories of “Catheter/Disposable Perfusion Set.” The Court found that this document was merely an administrative communication issued nearly two years after the alleged manufacture. It could reflect the department’s later understanding of the product but could neither take the place of a Gazette notification nor retrospectively supply the statutory foundation for criminal liability arising from conduct in 2010.
The High Court further noticed that subsequent consideration by an Expert Committee and related departmental communications showed that the precise classification of Heart Lung Packs remained a matter requiring examination. This subsequent material did not prove, with the certainty required in a criminal prosecution, that the product had already been brought within a duly notified category on the relevant date.
Relying upon Biogenetic Drugs (P) Ltd. v. State of Himachal Pradesh, the Court reiterated that the regulatory requirements contemplated by Section 3(b)(iv) cannot be created through an administrative order or office instruction in the absence of statutory authority.
The Court also referred to Kirti Kumar Jayantilal Patel v. State of Maharashtra, MANU/MH/1218/2023, wherein criminal proceedings were quashed because a manufacturer could not be prosecuted for failing to comply with a standard that had not been legally prescribed at the time of manufacture. A subsequent regulatory understanding could not be employed to retrospectively impose penal consequences.
Applying the rule of strict construction of penal statutes recognised in Tolaram Relumal v. State of Bombay, AIR 1954 SC 496, the High Court held that criminal liability could not be imposed where the statutory coverage of the product was uncertain. When a penal provision is capable of more than one reasonable interpretation, the interpretation exposing a person to punishment cannot be adopted unless every statutory requirement is clearly satisfied.
The Court clarified that the issue was not whether Heart Lung Packs could generally be regulated as medical devices. The decisive question was whether the particular product manufactured by the petitioners was legally a “drug” under Section 3(b)(iv) on October 28, 2010. No Gazette notification establishing such inclusion was placed before the Court.
The Court also rejected the contention that this classification dispute necessarily required a trial. The case did not demand a detailed appreciation of disputed evidence because the foundational issue concerned the legal applicability of the statutory regime upon documents already forming part of the record. Where the essential legal ingredient of the alleged offence is absent, the High Court may exercise its inherent jurisdiction to prevent an abuse of process.
Decision: The High Court allowed the petition and quashed Complaint No. 1231 dated July 16, 2013, the summoning order passed by the Chief Judicial Magistrate on the same date, and the revisional order dated October 29, 2014 passed by the Sessions Judge, Jhajjar. All consequential criminal proceedings against the company and its officers were also quashed. The Court expressly refrained from giving any general ruling on the present regulatory status of Heart Lung Packs as medical devices. Its decision was confined to the failure of the prosecution to establish that the product was validly notified as a “drug” on the date of the alleged manufacture in 2010.