Ayush ministry informs HC that it has instructed drug regulators against use of Unani label for Ayurveda drug
The Union Ministry of Ayush has submitted in the Delhi High Court that it has instructed the licensing authority for the Ayush systems of medicines in all the States and Union Territories that they should ensure that the labelling and naming of the products for the Ayurvedic and Unani drugs should be as per the provisions. The submission was particularly on the naming of almond oil in Ayurveda and Unani drugs.
The Ministry requested the State Licensing Authority to ensure that the ayurvedic drug license should be issued for Vatada Taila or Badal Taila and Unani drug license should be issued for Raughan-E-Bdam Shireen/Badam Shireen, as defined under Section 3 (a) of Drugs & Cosmetics Act, 1940 and in accordance with Rule 157 (1B) of the Drugs & Cosmetics Rules, 1945.
According to the Section 3(a) of the Act, the Ayurvedic, Siddha or Unani drug includes all medicines intended for internal or external use for or in the diagnosis, treatment, mitigation or prevention of diseases or disorder in human beings, or animals and manufactured exclusively in accordance with the formulae described in, the authoritative books of these systems of medicines, specified in the First Schedule of the Act.
The Rule 157(1B) states that no manufacturer shall use any prefix or suffix with the name of any Ayurvedic, Siddha or Unani Tibb drug falling under clause (a) of Section 3 of the Act, except as described in the authoritative books specified in the First Schedule to the Act. Provided that, a formulation without any specific name, described in the authoritative books may be named on the basis of the ingredients of the formulation, it added.
While the letter was issued in June, 2022, the submission to the High Court was made in the wake of a petition by the Hamdard National Foundation India and others against the Government of NCT, Delhi and the Ministry of Ayush, seeking directions that ayurvedic manufacturers ought not to be permitted to use the expression Rogan Badam Shirin/Roughan Shiree, for Badam Tail/Almond oil which as per them, is meant only for Unani medicines.
The Ministry informed the Court that it has issued letters to all the State Licensing Authorities regarding the subject.
In the letter, the Ministry said that it has come to the notice of the Ministry that many Ayurveda, Siddha and Unani drug manufacturers are not adhering to provisions for labelling and naming of the products in accordance with the drug license obtained.
It clarified that Raughan-E-Badam Shireen/Badam Shireen is mentioned as UnaniMedicine and Vatama of Vatada Taila is mentioned as Ayurveda medicine in their respective authoritative books in the First Schedule of Drugs and Cosmetics Act, 1940.
“In the view of the fact that the Respondent (Ministry of Ayush) has now communicated to the State Licensing authorities that the use of the name Raughan-E-Badam Shireen and Badam Shireen would require a Unani Drug License, the relief sought for in this petition according to the petitioner (Hamdard) stands satisfied and no further orders would be required,” said Justice Prathiba M Singh, in an order.
The Ministry, in another letter to the Deputy Registrar of Trade Marks and the GI, Head – Trade Marks Registry, in June, 2022, requested to review trade mark Hamdard Roshan Badam Shirin for using of descriptive term of classical medicine ‘Roshan Badam Shirin’ and prefix ‘Hamdard’, as it is a contraception of Rule 157 (1B) of Drugs and Cosmetics Rules, 1945.
On this letter, the Judge observed that let the Controller General of Patents, Designs & Trade Marks (CGPDTM) or the Trade Mark Registry proceed in accordance with law.
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