Himachal Pradesh HC Quashes State Drug SOP | Rule-Making Power Lies Only With Centre | Drug Controller Has No Statutory Backing Under Drugs And Cosmetics Act
Sanchayita Lahkar
The High Court of Himachal Pradesh Single Bench of Justice Ajay Mohan Goel has quashed a Standard Operating Procedure (SOP) issued by the State Drug Controller, stating it was "bereft of any authority in law" and "not sustainable in the eyes of law". The court concluded that the Office Order dated 04.06.2021 lacked statutory backing and was not supported by any legal sanction under the Drugs and Cosmetics Act, 1940, or the rules framed thereunder. Consequently, the court allowed the writ petition filed by the petitioners to the extent of invalidating the SOP, clarifying that other prayers raised in the petition could be pursued before the appropriate forums.
The court held that the SOP, which mandated certain procedures for sale and reporting of psychotropic substances, could not derive its legitimacy from a Central Government Notification that did not require such procedural mandates. The Bench unequivocally ruled that the SOP issued by the State Drug Controller lacked legislative or delegated legislative authority and thereby could not impose additional obligations on licensed manufacturers beyond what is statutorily prescribed. The impugned SOP was declared ultra vires and set aside.
The petitioners are pharmaceutical companies based in the State of Himachal Pradesh. They approached the High Court seeking several reliefs, including the quashing of seizure orders dated 12.04.2024, 09/10.05.2024, and 12.05.2024 pertaining to the seizure of medicines containing tramadol and alprazolam. These actions were alleged to have been carried out in violation of their rights under Articles 14, 19, 21, and 300A of the Constitution of India. The petitioners also challenged a Standard Operating Procedure (SOP) dated 04.06.2021 issued by the State Drug Controller.
When the matter was listed on 17.06.2025, counsel for the petitioners restricted their submissions to Clause-C of the reliefs sought in the writ petition, specifically challenging the validity of the SOP. As a result, the other reliefs were left to be pursued before appropriate fora.
According to the petitioners, the impugned SOP required pharmaceutical manufacturers to inform the Superintendent of Police and other State/District authorities about the sale of psychotropic substances. The petitioners argued that such conditions were beyond the jurisdiction of the State Drug Controller and had no support in the Drugs and Cosmetics Act, 1940 or the rules framed thereunder.
The petitioners submitted that the SOP was purportedly based on a Central Government Notification dated 11.02.2020, which came into effect on 01.03.2021. However, the petitioners asserted that the Notification did not justify the issuance of the SOP and contended that the Office Order was an overreach of statutory powers.
It was argued that the Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945 form a complete code, regulating the manufacture and sale of drugs comprehensively. Any imposition of additional conditions through an Office Order, without statutory backing, would be beyond the scope of the law. The petitioners asserted that the SOP could not be treated as a statutory notification or regulation, and its issuance was not supported by any express provision under the 1940 Act or the associated rules.
The State, in its reply, justified the issuance of the SOP by asserting that it was framed in public interest to address drug abuse and to ensure that psychotropic substances manufactured by companies did not fall into the wrong hands. It was contended that Sections 18B and 22 of the Drugs and Cosmetics Act empowered the Licensing Authority to issue the SOP. It was also submitted that the SOP was necessary to implement the Notification issued by the Central Government on 11.02.2020.
In rebuttal, the petitioners pointed out that the State's reply did not provide any specific legal provision authorising the issuance of the SOP. Instead, the response merely stated that it was issued in public interest. The petitioners stated that the Notification dated 11.02.2020, appended as Annexure P-4A, did not require any SOP to be issued for its implementation.
The Notification had introduced amendments to the Drugs and Cosmetics Rules, including defining the term "marketer" and adding Rules 84D and 84E. However, the petitioners contended that these amendments pertained to agreements between marketers and manufacturers and obligations regarding drug quality and regulatory compliance, not the imposition of obligations on manufacturers to share sale-related data with enforcement agencies.
The court observed that the petitioners had produced their licenses and product permissions (Annexure P-5) and that the SOP had effectively created additional compliance requirements not mandated by any statute or rule. The key issue for adjudication was whether the State Drug Controller had the legal authority to issue such an SOP.
The court examined the statutory framework governing the case and stated in clear terms that “the moot issue for the purpose of adjudication of this writ petition is in a very narrow premise. The same is whether the State Drugs Controller has any Authority in law to issue the impugned Office Order/ SOP or not.”
The judgment further recorded, “Section 18B of the Act has already been quoted by me hereinabove. This Section provides that every person holding a License under Clause (c) of Section 18 of the Act shall keep and maintain such records, registers under the documents, as may be prescribed and shall furnish to any Officer or Authority, exercising any power of discharging any function under this Act, such information as is required by such Officer or Authority for carrying out the purposes of this Act.”
It was observed that the Act clearly mandated that record-keeping responsibilities and the nature of documents to be maintained must be prescribed by Rules framed by the Central Government, not through an executive SOP issued by a State authority. The court stated, “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.”
Regarding Section 22 of the Act, the court found: “perusal thereof demonstrates 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.”
On the Notification dated 11.02.2020, the court noted: “There is no mention in this Notification that for the purpose of giving effect to the amendments carried out in the said Notification, any Office Order or SOPs, are required to be issued by the respective State Drug Controllers.”
The judgment stated that the SOP was not only unsupported by any statutory provision but also unconnected to the Central Government Notification relied upon for its justification. “Besides the fact that there is no mention in the Statutory Notification of issuance of any SOP for implementation thereof, one finds that the amendments carried by way of Notification Annexure P-4A, are otherwise also alien to the contents of the SOP.”
In further assessment, the court recorded: “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.”
The court also considered the pleadings and stated, “Reply filed by the State to these Paras of the writ petition demonstrates that it has not been specifically or otherwise stated by the State that the SOP has been issued by the State Drug Controller who had a legal mandate to issue the same.”
The court issued the following directive:
“Accordingly, in the light of the observations made hereinabove, this writ petition is allowed to the extent that impugned Office Order/SOP (Annexure P-4), dated 04.06.2021, issued by the State Drug Controller is quashed and set aside on the ground that the same has been issued without any Statutory backing, executive competence or legal sanction under the provisions of Drugs and Cosmetics Act, 1940 and the Rules framed thereunder to issue the same.”
It also recorded: “The petitioners may seek the other reliefs prayed in the writ petition, before the appropriate Fora, as advised.”
The court disposed of the petition in these terms and did not issue any order as to costs. It was also stated: “Pending miscellaneous application(s), if any also stand disposed of accordingly. No order as to costs.”
Advocates Representing the Parties:
For the Petitioners: Mr. R.S. Cheema, Senior Advocate, with Ms. Tanu Bedi, Advocate with M/s Ananya Verma and Ajay Thakur, Advocates.
For the Respondents: Mr. Anup Rattan, Advocate General, with Ms. Swati Draik, Deputy Advocate General, M/s Feery Sofat and Abhinav Ghabroo, Advocates, Mr. Janesh Mahajan, Advocate
Case Title: Biogenetic Drugs (P) Ltd. & another v. State of Himachal Pradesh & others
Neutral Citation: 2025: HHC:20463
Case Number: CWP No.4334 of 2025
Bench: Justice Ajay Mohan Goel
