Private member bill seeks to establish central optical devices quality control and vision care regulation

 Seeking to establish central optical devices quality control and vision care regulation a private member bill has been introduced in Parliament recently. The proposed bill, introduced by MP Ajeet Madhavrao Gopchade, seeks to offer remedy to the alleged vulnerability of consumers who according to the bill are in a “no-man’s land” between the manufacture of a lens and its delivery.

“While the National Commission for Allied and Healthcare Professions Act, 2021 regulates the professional, and the Drugs and Cosmetics Act regulates the “device” at the factory level, there is zero specific legislative oversight at the retail point-of-sale. This gap allows unscrupulous elements to operate testing clinics and retail shops without any technical accountability, leading to widespread medical negligence,’ it notes.

The spectacles as a spectacle

The MP, last month, in a question raised in Rajya Sabha sought information from the Union Health Ministry on whether it is aware that a substantial section of India’s population relies on spectacles and contact lenses for daily activities, thereby making accurate vision correction a critical public safety and public health concern and whether the absence of a uniform national regulatory mechanism for optometric services, covering eye testing, prescription accuracy, lens quality, fitting practices and professional accountability, may adversely affect vision health and contribute to road accidents. He also asked if the Government proposes examining the best international practices and considering establishing a statutory National Optical Regulatory Board to ensure quality?

In its response the Ministry maintained that as per national survey, Rapid Assessment of Avoidable Blindness (RAAB) 2019 data, refractive errors are responsible for visual impairment in 13.4% of the population above 50 years of age and 29.6% population below 50 years age. 

It added that the National Commission for Allied and Healthcare Professions (NCAHP) has been constituted, inter-alia, for regulation and maintenance of standards of education and services by allied and healthcare professionals listed under the Schedule of NCAHP Act, 2021. 

“The Optometrist profession (ISCO Code 2267) comes under the Sl. No 5 (Ophthalmic Sciences Professional) of Schedule of NCAHP Act, 2021. The curriculum for Optometry has been released by National Commission for Allied and Healthcare Professions (NCAHP) on 24.04.2025 which is available on the NCAHP website. Further, Central Drugs Standard Control Organization (CDSCO) regulates quality, safety, and performance of medical devices under the provisions of Drugs and Cosmetics Act, 1940 and Medical Devices Rules, 2017 thereunder. Spectacles/Contact lenses intended for vision correction are regulated as medical devices under Medical Devices Rules, 2017 and are required to comply with the applicable standards for ensuring quality, safety and performance as prescribed under the said rules,’’ it noted.

Meanwhile the proposed bill in its suggestion said that uncorrected or poorly corrected refractive errors are a “silent tax” on the Indian economy and that a significant percentage of road accidents in India can be traced back to poor driver vision. It added that due to lack of retail-level quality enforcement, India has become a dumping ground for low-grade, non-UV protected, and carcinogenic plastic lenses from international markets. 

It added that with the massive surge in screen time across all age groups, the quality of “blue-cut” and “anti-reflective” coatings has become a medical necessity.