While quashing a Standard Operating Procedure (SOP), the Himachal Pradesh High Court has ruled that Section 22 of the Drugs and Cosmetics Act does not confer any power upon the State Drug Controller to issue the same and the rule-making power is exclusively conferred upon the Central Government.

The Petitioners had approached the High Court seeking a direction to quash the action of respondents, i.e. seizure order/inspection report, memo of recovery vide which medicines manufactured by the petitioners containing tramadol and alprazolam along with their raw materials had been seized. A plea was also raised to declare Instructions/SOP-Standard Operating Procedure passed by the State Drug Controller as ultra vires and having no force of law, as the same has been issued beyond the executive competence.

The Single Bench of Justice Ajay Mohan Goel said, “ In this view of the matter, when the Rule making power is exclusively conferred upon the Central Government and the Central Government has in exercise of the powers so conferred , framed Rules which govern all the activities of manufacturers like the petitioners including the sale of drug manufactured, the Office Order in question which has been issued by the State Drug Controller, bereft of any Authority in law vested in the State Drug Controller to issue the same, is not sustainable in the eyes of law”, it held.

“Therefore, it cannot be said that Section 22 of the Act confers any power upon the State Drug Controller to issue the kind of Notification which stands assailed in this writ petition”, it added.

Senior Advocate R.S. Cheema represented the Petitioners while Advocate General Anup Rattan represented the Respondent.

Factual Background

The petitioners claiming to be Pharmaceutical Companies based in the State of Himachal Pradesh were being pointed out as accused qua commission of offences under the provisions of the Narcotic Drugs and Psychotropic Substances Act, 1985, because of alleged violation of a Standard Operating Procedure (SOP). As per the petitioners, the SOP had been issued by the State Drug Controller without any statutory backing or sanction.

The SOP requires, sending information of sale of psychotropic substance to the Superintendent of Police and other Authority of the State/District where the purchaser is located and as per the petitioners, though the State Drug Controller has no power to incorporate such conditions either under the Drugs Control Act or the Drugs Control Rules, yet an attempt had been made to create a legal justification by referring to the notification of the Central Government.

Reasoning

The Bench noted that as per the Government Notification, there was no mention therein that to give effect to the amendments carried out in the said Notification, any Office Order or SOPs were required to be issued by the respective State Drug Controllers. Referring to Section 18B with Clause (ee) of sub-section (2) of Section 33 of the Drugs and Cosmetics Act, 1940, the Bench observed that the records, registers or other documents which are to be kept and maintained under Section 18B of the Act and have to be maintained in the mode and manner as the Rules framed by the Central Government may prescribe.

The Bench also explained that in terms of Section 22 of the Act, power of inspection has been conferred upon any Inspector, and this is specifically made subject to the provisions of Section 23 of the Act and the Rules framed by the Central Government. “As already observed hereinabove, Notification, dated 11.02.2020, does not command issuance of any SOP for implementation thereof by the State Drug Controller. Otherwise also, this is a Statutory Notification issued by the Central Government carrying out amendments in the Drugs and Cosmetics Rules. The Act and the Rules are self-speaking that what are the results of the violation thereof”, it stated.

The Bench was of the view that in the absence of there being any legal authority vested in the State Drug Controller to issue the impugned Office Order, the justifications given by the State Government sans any legal backing/ sanction or legal authority vested with the State Drug Controller to issue the same, cannot justify the issuance of said Office Order.

The Bench thus disposed of the writ petition by quashing the impugned Office Order/SOP, issued by the State Drug Controller.

Cause Title: Biogenetic Drugs (P) Ltd. & another v. State of Himachal Pradesh & others (Neutral Citation: 2025:HHC:20463)

Appearance

Petitioners: Senior Advocate R.S. Cheema, Advocates Tanu Bedi, M/s Ananya Verma and Ajay Thakur

Respondents: Advocate General Anup Rattan, Deputy Advocate General Swati Draik, Advocates M/s Feery Sofat and Abhinav Ghabroo, Advocate Janesh Mahajan

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Himachal Pradesh High CourtJustice Ajay Mohan Goel

Tulip Kanth

Assistant Editor

Tulip Kanth is an Assistant Editor at Verdictum having over 5 years of experience in the field of legal journalism and editing. She extensively covers judgments of the Supreme Court, High Courts as well as Tribunals. She has previously worked with a legal publishing website where she oversaw the work of other editors and has also created updates on notifications of different Government Ministries. She holds an English Honours Degree from SGTB Khalsa College, Delhi University and has completed her LLB course with specialisation in Corporate Law from Amity University.