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During COVID 19 pandemic situation licensing approvals for Surface Disinfectant and Floor Cleaners have been granted by various AYUSH Licensing Authorities as Ayurvedic Drugs and this has triggered the discussion on legal status of such approvals. Now question arises whether these Surface Disinfectant and Floor Cleaners Solutions are Ayurvedic Drugs ?
Ayurvedic Drugs are defined under Section 3(a) of Drugs and Cosmetics Act 1940 (Drugs Act) which clearly states that it includes all Medicines intended for internal or External use for diagnosis, treatment, mitigation or prevention of Disease or Disorder in human beings or animals and manufactured in accordance with the formulae authoritative books of Ayurveda specified in First Schedule.
Analyzing this, it is clear beyond doubt that:
- Surface Disinfectant and Floor Cleaners are not for internal or external use of Human beings or animals. These are for use on inanimate surfaces which in no way fits in definition of Ayurvedic Drugs given in Section 3 (a) of Drugs Act.
- Formulae approved for these products are not mentioned in Authoritative Books mentioned in First Schedule of Drugs Act. Since this First Schedule specifying the authoritative books appended to Drugs Act becomes part of Act therefore no rule can even allow the permission of such formulation which is not mentioned in authoritative books.
Even Patent and Proprietary medicine in relation to Ayurvedic as defined under Section 3(h)(i ) of Drugs Act do not allow the Surface Disinfectant as Ayurvedic Drug .
Standrads for Disinfectant as Ayurvedic Drugs are not prescribed under Drugs Act and Rules which again confirms that these products should not be allowed to be manufactured as Ayurvedic Drugs.
Schedule T under Rule 157 prescribes Good Manufacturing Practices for Ayurvedic Medicines. Part II Schedule T provides Minimum Manufacturing Space and Machinery for various Category of Medicine in which surface disinfectant by any name are not found included.
Rule 161B prescribes the Shelf life or date of expiry for various groups of Ayurvedic Medicine in which 32 types of groups of Ayurvedic Medicines are mentioned but Surface Disinfect are not found mentioned which again confirms that Surface Disinfectant and Floor Cleaners are not Ayurvedic Drugs.
Rule 161 prescribes Labelling, Packing and Limit of Alcohol and specially maximum pack size of limit of Alcohol as base given in Rule 161(x) in which maximum content of Alcohol limited to 16% and maximum size of packing for Mritsanjivni Sura 30 ml and for Mahadrakshasav 120 ml therefore Surface Disinfectant and Floor Cleaners having high Alcohol Content can not be allowed to be manufactured as Ayurvedic Drug.
All these provisions clearly shows that Surface Disinfectants Floor Cleaners are not covered under Ayuvedic Drugs and should not be permitted as Ayurvedic Drugs.
Narender Ahooja Vivek, Author is working as State Drugs Controller, Food and Drugs Administration, Haryana
Disclaimer: This is the personal opinion of the writer and anyone may have a different opinion about this product and will not attract any legal implication.
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