Himachal Pradesh High Court Quashes SOP Issued By State Drug Controller
Whereas quashing a Commonplace Working Process (SOP), the Himachal Pradesh Excessive Courtroom has dominated that Part 22 of the Medicine and Cosmetics Act doesn’t confer any energy upon the State Drug Controller to problem the identical and the rule-making energy is completely conferred upon the Central Authorities.
The Petitioners had approached the Excessive Courtroom in search of a path to quash the motion of respondents, i.e. seizure order/inspection report, memo of restoration vide which medicines manufactured by the petitioners containing tramadol and alprazolam together with their uncooked supplies had been seized. A plea was additionally raised to declare Directions/SOP-Commonplace Working Process handed by the State Drug Controller as extremely vires and having no drive of regulation, as the identical has been issued past the manager competence.
The Single Bench of Justice Ajay Mohan Goel stated, “ On this view of the matter, when the Rule making energy is completely conferred upon the Central Authorities and the Central Authorities has in train of the powers so conferred , framed Guidelines which govern all of the actions of producers just like the petitioners together with the sale of drug manufactured, the Workplace Order in query which has been issued by the State Drug Controller, bereft of any Authority in regulation vested within the State Drug Controller to problem the identical, will not be sustainable within the eyes of regulation”, it held.
“Due to this fact, it can’t be stated that Part 22 of the Act confers any energy upon the State Drug Controller to problem the form of Notification which stands assailed on this writ petition”, it added.
Senior Advocate R.S. Cheema represented the Petitioners whereas Advocate Common Anup Rattan represented the Respondent.
Factual Background
The petitioners claiming to be Pharmaceutical Corporations primarily based within the State of Himachal Pradesh had been being identified as accused qua fee of offences underneath the provisions of the Narcotic Medicine and Psychotropic Substances Act, 1985, due to alleged violation of a Commonplace Working Process (SOP). As per the petitioners, the SOP had been issued by the State Drug Controller with none statutory backing or sanction.
The SOP requires, sending info of sale of psychotropic substance to the Superintendent of Police and different Authority of the State/District the place the purchaser is situated and as per the petitioners, although the State Drug Controller has no energy to include such circumstances both underneath the Medicine Management Act or the Medicine Management Guidelines, but an try had been made to create a authorized justification by referring to the notification of the Central Authorities.
Reasoning
The Bench famous that as per the Authorities Notification, there was no point out therein that to offer impact to the amendments carried out within the stated Notification, any Workplace Order or SOPs had been required to be issued by the respective State Drug Controllers. Referring to Part 18B with Clause (ee) of sub-section (2) of Part 33 of the Medicine and Cosmetics Act, 1940, the Bench noticed that the information, registers or different paperwork that are to be stored and maintained underneath Part 18B of the Act and should be maintained within the mode and method because the Guidelines framed by the Central Authorities might prescribe.
The Bench additionally defined that by way of Part 22 of the Act, energy of inspection has been conferred upon any Inspector, and this is particularly made topic to the provisions of Part 23 of the Act and the Guidelines framed by the Central Authorities. “As already noticed hereinabove, Notification, dated 11.02.2020, doesn’t command issuance of any SOP for implementation thereof by the State Drug Controller. In any other case additionally, it is a Statutory Notification issued by the Central Authorities finishing up amendments within the Medicine and Cosmetics Guidelines. The Act and the Guidelines are self-speaking that what are the outcomes of the violation thereof”, it said.
The Bench was of the view that within the absence of there being any authorized authority vested within the State Drug Controller to problem the impugned Workplace Order, the justifications given by the State Authorities sans any authorized backing/ sanction or authorized authority vested with the State Drug Controller to problem the identical, can not justify the issuance of stated Workplace Order.
The Bench thus disposed of the writ petition by quashing the impugned Workplace Order/SOP, issued by the State Drug Controller.
Trigger Title: Biogenetic Medicine (P) Ltd. & one other v. State of Himachal Pradesh & others (Impartial Quotation: 2025:HHC:20463)
Look
Petitioners: Senior Advocate R.S. Cheema, Advocates Tanu Bedi, M/s Ananya Verma and Ajay Thakur
Respondents: Advocate Common Anup Rattan, Deputy Advocate Common Swati Draik, Advocates M/s Feery Sofat and Abhinav Ghabroo, Advocate Janesh Mahajan
