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CDSCO issues advisory to expedite application process of homoeopathic hand sanitisers

Experts seek more clarity on the issued advisory and insist that SLAs should ensure quality compliance before granting permission for manufacture

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The Central Drugs Standard Control Organisation (CDSCO) has issued an advisory to licensing authorities and drug Controllers of homoeopathy in all States and Union Territories, to expedite the application process for grant of approval, license, and renewal of license for hand sanitisers.

It mentions that the State Licensing Authorities (SLAs) are requested to complete the licensing/approval process expeditiously and dispose of the applications of hand sanitisers at the earliest.

In the advisory, the Director of the Homoeopathic Pharmacopoeia Laboratory (HPL) (Ministry of AYUSH) has stated that since glycerine and alcohol are mentioned in the homoeopathic pharmacopoeia, they should be taken into the consideration by State Licensing Authority (SLA) while granting license for hand sanitisers to homoeopathic manufacturers.

However, commenting on the issued advisory, a retired Drug Controller of Haryana, said, “It is a welcome step that homoeopathic manufacturers are being permitted to manufacture hand sanitisers, since they are already using ethanol (ethyl) in the manufacturing of homoeopathic medicines. The letter of DCGI is clear to the extent that they can manufacture hand sanitisers only by using ethanol and not by using isopropyl alcohol. A bottleneck is Rule 106-B, which prohibits the sale of homoeopathic medicine which contains more than 12 per cent ethanol, in a bottle of more than 30 ml.”

He further elaborated, “In the case of homoeopathic medicine, the percentage of alcohol needs to be mentioned on the label but in the case of cosmetics, it is not mandatory. The words, ‘homoeopathic medicine’ needs to be mentioned on the label if it is manufactured under homoeopathic license on form 25-C under Drug Rules & homoeopathic medicines which can be sold by a retailer, who is holding a license on Form 20-C for sale of homoeopathic medicines. In addition, that the sale of homoeopathic hand sanitizers can also be done by retail chemists who hold retail license on Form- 20 & 21under Drug Rules in addition to the dealers who hold license to sell homoeopathic medicines on Form 20-C as per the amendment made in the Rules subject to certain conditions.”

He also informed that, “In my letter to the DCGI dated May 16, I have already suggested for the uniformity in the law for the manufacture of hand sanitisers, since these are now being manufactured under different systems of medicine and as cosmetics, which also have different provisions of labelling.”

Dr Kamlesh Shende, Ex-Technical officer and Joint Commissioner, Maharashtra FDA said, “The issued advisory by the CDSCO is silent on the formulas of hand sanitisers. The office of DCGI should have advised the SLA on the formula, its quality control parameters and labelling provisions, as well as the method of usage by consumers, the quantity to be applied etc. Due to this shortfall, it is likely that the market can get flooded with inappropriate, unsafe and inefficacious sanitisers. The Drugs and Cosmetics Act 1940 and Rules do not give enough information on the aforementioned areas for products which are to be approved as sanitisers, under a homoeopathic license. In the absence of these unspecified provisions for homoeopathic products the manufacturers are free to bring all types of products in the market.”

Manmohan Taneja, Assistant State Drugs Controller, FDA-Haryana commented, “The issued letter doesn’t mention anywhere that an SLA shall grant a licence or approval for homoeopathic hand sanitisers. Through the advisory letter, the DCGI is only conveying that Director HPL, Ministry of AYUSH had opined that ingredients like glycerine and alcohol were mentioned in the homoeopathic pharmacopoeia of India (HPI), and therefore the DCGI has written this for SLAs consideration only. The consideration of SLAs may or may not be in favour of granting the licence to the manufacturer of homoeopathic hand sanitisers. The definition of homoeopathic medicines as per rule 2(dd) includes not only ingredients contained in HPI or their combination, but also techniques of manufacture, therapeutic efficacy or homoeopathic provings. Moreover, the principles of homoeopathic medicines also need to be looked into.”

Dr GL Singla, Retired Drug Controller of Haryana said, “Considering the pandemic situation due to