Drugs & Cosmetics Act | ‘Rule-Making Power Lies Only With Centre’: HP High Court Quashes SOPs By State Drug Controller
The Himachal Pradesh Excessive Courtroom has held that the State Drug Controller doesn’t have the authority to problem an Workplace Order or Customary Working Process, as rule-making energy underneath the Medicine & Cosmetics Act lies completely with the Central Authorities.
Justice Ajay Mohan Goel: “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 legislation vested within the State Drug Controller to problem the identical, isn’t sustainable within the eyes of legislation.”
Background Info:
The petitioners on this writ petition are pharmaceutical firms in Himachal Pradesh licensed to fabricate medicines, together with medication containing psychotropic substances comparable to tramadol and alprazolam.
The dispute arose when the State Drug Controller performed inspections of the petitioners’ manufacturing items. Thereafter, by an Workplace Order dated June 4, 2021, the Drug Controller directed producers to submit particulars of gross sales of psychotropic substances to the police and district authorities. The petitioners have been additionally served with seizure orders, inspection experiences, and restoration memos.
Aggrieved by the seizure orders, the petitioners filed a writ petition earlier than the Excessive Courtroom, stating that they have been being handled as accused in relation to the fee of offences underneath the provisions of the Narcotic Medicine and Psychotropic Substances Act, 1985, as a result of the Drug Controller alleged that they’d violated the Customary Working Process.
Contentions:
The petitioners contended that the Customary Working Process was not legally legitimate because the State Drug Controller didn’t have any authority underneath the Medicine and Cosmetics Act, 1940 to problem it. Additional, the Customary Working Process was neither a Statutory Notification, nor a Statutory Regulation, and neither the Medicine & Cosmetics Act nor the Guidelines framed thereunder confer any such energy upon the State Drug Controller to problem any such workplace order.
They additional submitted that the Customary Working Process wrongly referred to a Central authorities notification dated February 11,2020 issued by the Ministry of Well being & Household Welfare. As a easy studying of the Notification confirmed that it didn’t require or authorise the issuance of any such Customary Working Process. The Notification solely handled amendments to sure Guidelines associated to entrepreneurs and labelling duties; it didn’t direct State Drug Controllers to impose new reporting necessities.
In response, the State contended that the Customary Working Process was issued within the bigger public curiosity to manage drug abuse and to make sure that medication manufactured by Firms just like the petitioners didn’t land within the incorrect palms. It additional submitted that the issuance of the Customary Working Process was in response to the powers given to the drug controller underneath Sections 18B and 22 of the Act, for monitoring the actions carried out by producers.
Findings:
The Courtroom famous that the Medicine and Cosmetics Act, 1940, was enacted to control the manufacture, distribution and sale of medicine and cosmetics. As per Part 2(b) of the Act, the definition of drug “covers all medicines for inner or exterior use in people or animals, substances used for prognosis, remedy, prevention, or mitigation of illness, parts used to make a drug and sure medical gadgets notified by the Central Authorities”.
Analyzing the notification referred to, the Courtroom noticed that the Central Authorities had used its powers underneath Sections 12 and 13 of the 1940 Act, and in session with the Medicine Technical Advisory Board, amended the Medicine and Cosmetics Guidelines, 1945, as represented within the Notification. Nonetheless, nowhere did the notification point out that for the implementation of this notification, any Workplace Order was required to be issued.
It additional acknowledged that underneath Part 33 of the Act, the ability to make guidelines to hold out the needs of the Act lies completely with the Central authorities and offers with the manufacture, sale, and distribution of medicine & cosmetics.
The Courtroom famous that, in response to part 18B learn with part 33(2)(ee) of the Act, it’s clear that data and paperwork should be maintained in accordance with the Guidelines framed by the Central Authorities. Equally, Part 22 of the Act solely authorises the drug controller to hold out inspections as per the foundations prescribed by the Central Authorities, nevertheless it doesn’t authorise it to problem the form of Workplace Order challenged on this writ petition.
The Courtroom concluded that it was clear from the provisions of the Act and the Guidelines shaped by the Central Authorities that all the pieces was already coated, together with how details about the provision and sale of medicine should be given. Any non-compliance with these guidelines is punishable by way of the provisions of the Medicine and Cosmetics Act, 1940, which is each a substantive and a procedural legislation.
For the reason that energy to make guidelines vests with the Central authorities, which has already framed Guidelines governing the actions of producers just like the petitioners, together with the sale of medicine, the Customary Working Process issued by the State isn’t sustainable within the eyes of the legislation.
Thus, the Excessive Courtroom quashed the Customary Working Process, holding that it had been issued with none statutory backing, government competence, or authorized sanction underneath the Medicine and Cosmetics Act, 1940 and the Guidelines framed underneath it.
Case Title: Biogenetic Medicine (P) Ltd. & one other v/s State of H.P. & Ors.
Case No.: CWP No. 4334 of 2025
Date of Determination: 30.06.2025
For the Petitioners: Mr. R.S. Cheema, Senior Advocate, with Me, Tanu Bedi,Advocate (by V.C.), with M/s Ananya Verma and Ajay Thakur, Advocates.
For the Respondents: Mr. Anup Rattan, Advocate Basic, with Ms. Swati Draik, Deputy Advocate Basic, for respondents No. 1 and 2-State.M/s Feery Sofat and Abhinav Ghabroo, Advocates, for respondent No.3. Mr. Janesh Mahajan, Advocate, for respondent No.4.
