What If Optical Products Are Categorised As Medical Devices?

What If Optical Products Are Categorised As Medical Devices?

The optical industry is grappling for answers to the questions, raised by the recent government notifications, on its classification of optical products such as frames and sunglasses, as medical devices and asking for the registration of optical dispensing business under Drug Controller Of India. 

The latest notifications of the government of India, proposing to bring optical products under medical products device classification, and to register the business under Drug Controller of India, has brought the whole optical industry in a deliberating mode, to understand the implications of it on the trade. The general view, however, is that this is most unexpected and if it becomes law the effect will be different for each segment of the trade - manufacturing, distributing and retailing. 

Many who understand the business aspect well. because of their experience have started to join or invite to join hands with others to find a way, first to understand the government proposal and then take decisions on whether to put forward the collective representation of the industry to oppose, change or modify the proposal, before making it a law. 

Rajasthan Optical Trade & Industry (ROTI) seems to be the first to invite the heads, of countrywide optical associations, on a webinar to discuss the topic and some of the participants did put forward their thoughts that mainly emphasised the fact that the notification, if turned into law, would affect big time and that unorganised section of the retailers across the country would have to shut shop. The proposal seemed beneficial to the corporate sector of the industry and the ophthalmologist and optometrist community. So, at this point of time, there are more questions than answers on how it will implicate the industry as a whole. 

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To have an expert’s view on the subject we asked P Ramchandran (Ram), Management Consultant - Eye Care, to share his views and here’s what he has to say:

The Directorate General Health Services Central Drugs Standard  Control Organisation has issued a notice dated Sept 3, 2020, for classification of non notified medical devices. This is further to the circular published on Feb 11, 2020. The medical devices which are under the definition will be regulated in a phase-wise manner, in accordance with Centre Licensing Authority, that needs to classify such medical devices as per the risk-based approach. The department has been kind enough, in asking for comments/ feedback of the proposed add on of products, under medical devices from all stakeholders and associations. 

Now coming to Optical products - spectacle frames, lenses, sunglasses and goggles to name a few, pertaining to the optical sector falls under Class A low-risk category, while contact lenses fall under Class B Medium Risk. The spectacle is a product that enhances the vision and is not invasive in a layman's language and sunglasses offers protection to the eyes from the glaring sun. In my opinion contact lenses perhaps may have to go under Medical Device as there must be qualified professional to dispense a contact lens to a wearer.  

Coming to the Indian optical scenario, the need of the hour is to support the Indian entrepreneurs to replace the imports happening from China in most of the categories of optical products. Atmanirbhar is very much relevant to opticals now than ever, as much as the toy manufacturing industry in India. As a first step, there must be an industry representation to the Government for a dedicated optical corridor in India and encourage import substitution. In addition, the optical retailers are going through the most turbulent times - beginning with online and then the pandemic and any regulation will add to complex procedures to be adapted and cost thereof. Also, the presence of optical stores are very much skewed towards metros, mini-metros and up to Tier 2 cities, wherein access for testing and buying spectacles remains a problem in the rural sector. 

Given that the Indian optical industry is highly fragmented and employs a very large workforce in the back-end of the service sector, it would be prudent to request the Government for removal of 'low-risk products' falling under proposed Medical Devices while recognising the fact that Indian optical industry will follow all norms that would assist the Government in making Indian population see better.

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