Ministry Of Health And Controller Of Drugs Takes A Right Step In Public Interest
On February 11, 2020, the Government of India gazetted two notifications – a new definition of medical devices and The Medical Devices (Amendment) Rules, 2020. The cumulative effect of these two notifications is that medical devices will be brought under the fold of quality and safety regulation from the effective date of both notifications – April 1, 2020.
From 1st April 2020 Drugs controller General of India has opened registration of Opticians and Optometrists dealing in Spectacle Frames, Optical lenses, Contact Lenses , Contact Lenses Solutions and Low Vision Devices. Post 11th August 2022 it becomes mandatory and not obtaining a registration and having a valid licence will be a criminal offence and will attract fine and imprisonments as per Drug and Cosmetic Act .
Optical frames / optical lenses lenses , contact lenses , contact lenses solution and Low vision devices like telescopes are presently unregulated have now been placed under medical devices at par with drugs and will be covered by Drug and Cosmetic Act 1940.
Spectacle frames , Optical lenses and low vision telescopes are classified as Class A (low-risk) can’t be sold without a registration with Drug controller General of India .
Contact lenses are classified as Class B (low-medium risk) product .Contact lenses as medical devices will need a licence and registration too . Contact lenses solutions are classified as class C ( moderate - High risk ) products . On line and off line sale of contact lenses and contact lenses solutions will need a licence of eye health care provider post August 2022. Online companies will have to confirm from the prescribing health care provider about validity and authenticity of a prescription prior to sale of contact lenses like in other countries .
Manufacturers , importer and retailers need to apply to Controller of drugs to register and obtain a licence to sell any of the above products . Vendors will undergo inspections from time to time as per latest “MDR Amendment “ . The manufacturer need to make sure that the products have ISO certification 13485 and follow standards and safety protocols .
WHO recognises three healthcare providers in eye care domain which includes Ophthalmologist , Optometrists and Opticians . While in India the profession of Opticians was granted as trade but in most developed and developing countries profession is regulated and licensed .
To be at par with rest of the world India adopts GHTF countries recommendation for classification of medical products . GHTF ( Global Harmonization Task Force was created in 1993 by US , EU countries , Australia and Japan and more countries for uniform classification of medical products .
The products are bought in to umbrella of Drug and Cosmetic act and amendments are made from time to time . In 2005 IOL too were classified as medical devices and needed a licence to trade in .
Contact lenses in India are over the counter product and can be sold openly by any one on line and off line . As per the MDR amendment now contact lenses are classified as class B in medical product categories and post 2022 contact lenses will not be sold without a prescription through off line of online .
Class B products are low to medium risks products and are sold by registered retailers only on the prescription of health care professionals . In all probabilities Optometrists will get right to prescribe glasses and contact lenses post AHP bill implementations .
Though many opticians feel that spectacle frame and optical lenses are both medical device and have no risk but optical profession is an educated, regulated and licensed profession in most part of the world and needs expertise and skills to dispense spectacle .
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