सर्जिकल ट्यूब ने हरियाणा फर्म को 15 साल तक अदालत में बांधे रखा, हाई कोर्ट ने दी रिहाई

Gurugram: A piece of surgical tubing kept a Bahadurgarh company in court for 15 years. This week, the Punjab and Haryana High Court finally set it free.

Justice Manisha Batra quashed criminal proceedings against Super Cardio Devices Private Limited and its two directors, ending a prosecution that began with a factory inspection in 2010, survived a trial court summons, and a failed revision petition along the way.

The company makes heart-lung packs—tubing systems used to carry fluids during open-heart surgery. In October 2010, the Drugs Control Officer, Jhajjar, inspected the company’s unit at Modern Industrial Estate (MIE) Part-A, Bahadurgarh, and found it manufacturing the packs without a drug manufacturing licence.

A second inspection followed in April 2012. The state then prosecuted the company and its directors under the Drugs and Cosmetics Act, and the Chief Judicial Magistrate, Jhajjar, summoned them in July 2013. A revision against that summoning order was dismissed by the Sessions Judge, Jhajjar, in 2014.

The company then moved the high court, arguing that the heart-lung pack was never legally a ‘drug’ to begin with.

Under the Act, a medical device only becomes a ‘drug’ if the Central government specifically notifies it in the Official Gazette. Counsel for the company pointed to a 2005 government notification that listed 10 categories of devices, including catheters, but did not name heart-lung packs. The company argued the product was a distinct item, a tubing circuit that carries fluid outside the body during surgery, not a catheter inserted into a patient.

The state leaned on later paperwork. A 2009 clarification from the drug regulator listed the heart-lung pack among 19 devices covered under the law. A 2012 letter went further, stating the product fell under ‘catheter’ and ‘disposable perfusion set’ categories that had already been notified.

The court found problems with both documents. The 2009 clarification, it noted, was never issued as an Official Gazette notification, and a circular issued weeks later showed the government itself had referred the matter to the health ministry for approval, directing that old practices continue “until further orders”.

The 2012 letter came two years after the alleged offence and was only an administrative communication, not a formal notification.

Justice Batra held that the case could not go forward without a clear notification in place at the time of the alleged offence in 2010. “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 court observed.

The judgment leaned on a Himachal Pradesh High Court ruling that regulatory requirements cannot be created through office instructions in place of a Gazette notification, and on a Bombay HC decision holding that manufacturers cannot be penalised for standards that did not exist at the time of manufacture.

It also cited a 1954 Supreme Court ruling that penal laws capable of more than one reading cannot be stretched to punish a person unless the law’s requirements are clearly met.

The court was careful to note it was not ruling on whether the heart-lung pack should be regulated as a medical device going forward, only that the prosecution over the 2010 manufacture could not stand. “The subsequent administrative communications… cannot retrospectively supply the requirement of a statutory notification so as to sustain criminal liability for the alleged manufacture in the year 2010,” it held.

With that, the 15-year-old complaint, the summoning order and the Sessions Court’s order dismissing the revision were all quashed.

(Edited by Nardeep Singh Dahiya)

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