Madras High Court Calls For Licensing To Import Ayurvedic Drugs, Says Existing Rules Should Be Modified To Prescribe Standards
The Madras Excessive Courtroom has not too long ago noticed that the legal guidelines referring to the import of medicine would additionally apply to ayurvedic medication. Highlighting the absence of correct utility varieties for the import license of ayurvedic medication, the courtroom recommended that the prevailing guidelines must be modified to prescribe requirements.
“As held above, the statute and guidelines framed thereunder apply to ayurvedic medication. As regards import, whereas Rule 23 makes use of the expression “medication” and never medication utilized in allopathy, the varieties referred to therein and in Rule 24 don’t apply to the import of ayurvedic or non-allopathic medication. Subsequently, it’s obligatory for the rule making authority to change present guidelines, prescribe requirements and put together applicable varieties through which purposes could also be made and import licenses granted to individuals importing ayurvedic medication,” the courtroom stated.
Justice Senthilkumar Ramamoorthy famous that there was a powerful public component concerned within the import of medicine, and it was obligatory to manage non-allopathic medicines additionally, which may have heavy steel content material. Thus, the courtroom careworn the necessity to modify the prevailing statutes. It added that the Parliament may, within the various, prohibit the import of ayurvedic or different courses of medicine if obligatory.
“There’s a robust public curiosity component, particularly public well being component, in relation to the import of medicine…It’s conceivable, nevertheless, that different non-allopathic medicines may have, for instance, heavy steel content material and, due to this fact, the necessity for regulation can’t be disregarded. Within the various, as a coverage measure, it’s all the time open to Parliament to amend the regulation and prohibit the import of ayurvedic or different courses of medicine, if deemed match,” the courtroom noticed.
The courtroom was coping with a petition filed by M/s. Axeon Advertising India, which was the authorised importer and distributor of Axe Model Medicated Oil merchandise in India. The petition was filed in opposition to the notices issued by the State Licensing Authority alleging violation of Part 33EEA of the Medicine and Cosmetics Act, 1940 and Rule 154 of the Medicine and Cosmetics Guidelines, 1945
Part 33EEA offers with ayurvedic medication which might be deemed to be spurious underneath sure circumstances. Rule 154 of the Frugs and Cosmetics Guidelines offers with Type of licence to fabricate Ayurvedic (together with Siddha) or Unani medication.
The corporate argued that although its merchandise had been labeled as ayurvedic medication, the provisions in relation to import of medicine was not relevant to ayurvedic medication. The corporate argued that as per Rule 23, import licence must be issued in Kind-10 or Kind 10A and as per Rule 24, utility for import licence must be made in Kind-8 or Kind-8A with an enterprise in Kind-9. The corporate highlighted that none of those varieties had been relevant or applicable for ayurvedic medication.
The Extra Advocate Basic nevertheless submitted that the definition of medicine underneath the Act encompasses ayurvedic medication. It was additionally submitted that for the reason that Act and the Guidelines had not specified licensing necessities for ayurvedic medication, it must be understood that import of ayurvedic medication is prohibited. The AAG highlighted that within the absence of guidelines, the courts mustn’t prescribe licensing norms and even when the courtroom was to allow clearance of consignment, it must be topic to the satisfaction of norms prescribed for manufacturing ayurvedic medication in India.
The courtroom famous that the Guidelines supplied for an import licence to import medication and no carve out had been made in relation to ayurvedic or different medication. Thus, the courtroom opined that parliament’s intention was to prescribe import license for all medication.
Nevertheless, the courtroom additionally famous that varieties prescribed underneath the Guidelines are inappropriate for ayurvedic medication and applicable just for allopathic medication. This prompted the courtroom to recommend modifying the prevailing guidelines to make sure import license for ayurvedic medication.
On the identical time, noting that the standing had not exempted or prohibited the import of ayurvedic medication, the courtroom famous that it was obligatory to make sure that the merchandise had been in conformity with the requirements prescribed for comparable merchandise, manufactured in India.
Thus, the courtroom ordered that the corporate’s consignment must be examined in a laboratory accredited to the Central Medicine Commonplace Management Organisation (CDSCO), which should be overseen by the licensing authority. The courtroom added that if a passable report is obtained from the laboratory, the authorities ought to certify that the manufacturing course of is in conformity with the method prescribed for the manufacture of ayurvedic medication in India, and the products must be launched. The courtroom added that your complete train must be accomplished inside 8 weeks and the expense for the testing must be borne by the corporate.
Counsel for Petitioner: Mr. Hari Radhakrishnan
Counsel for Respondents: Ms.Revathi Manivannan, Mr.ARL.Sundaresan, Assisted by Mr.V.Chandrasekaran, SPC, Ms.M.Sneha, Spl. Counsel
Case Title: M/s.Axeon Advertising India v. The Assistant Commissioner of Customs (Group 2) and Others
Quotation: 2025 LiveLaw (Mad) 231
Case No: W.P.Nos.8920, 8924 & 8928 of 2025