Clear vision is fundamental to education, employment, road safety, productivity and healthy ageing. It is estimated that 2.2 billion people worldwide require vision correction, while at least one billion people continue to live with avoidable vision impairment, despite the availability of a simple, effective and affordable solution—a pair of prescription spectacles.
The WHO SPECS 2030 initiative provides a global roadmap to improve access to refractive error services through Services, Personnel, Education, Cost and Surveillance. Its objective is to increase effective refractive error coverage by making quality vision correction accessible and affordable for all.
Equally important, the World Health Organisation recognises spectacles as an essential assistive product in its Priority Assistive Products List. Like hearing aids and wheelchairs, prescription spectacles enable people to learn, work, remain independent and participate fully in society.
As India strengthens its Medical Device framework, the Central Drugs Standard Control Organisation notified the inclusion of mass-manufactured (prefabricated) prescription spectacles as Item 801 under the medical devices classification. Spectacles are an important step towards ensuring quality and patient safety. However, there is a need to clearly distinguish these products from individually custom-manufactured prescription spectacles.
Mass-manufactured prescription spectacles are produced in predetermined specifications before any consumer is identified. They are manufactured in bulk, carry standard optical parameters and are intended for general distribution and are normally known as Readers
In contrast, custom-manufactured prescription spectacles are fabricated only after a qualified eye examination and an individual prescription. Each pair incorporates patient-specific parameters including sphere, cylinder, axis, pupillary distance, fitting height, prism where required, frame geometry and lens centration. Once manufactured, they are unique to a single individual and cannot be used by another patient.
Most mature regulatory systems recognise this distinction by treating customised prescription products differently from standardised mass-produced products. Such an approach preserves patient safety while avoiding unnecessary regulatory burden.
A simple clarification from the CDSCO in India’s regulatory framework would remove ambiguity:
“Mass-manufactured (prefabricated) spectacles shall mean Readers manufactured in predetermined specifications without individual patient customisation. Prescription spectacles individually fabricated against a patient’s prescription and dispensing measurements, including pupillary distance, fitting height, prism and other patient-specific parameters, shall be regarded as custom-manufactured prescription spectacles.”
Such clarification would support patient safety, improve regulatory certainty, encourage innovation and domestic manufacturing, protect MSMEs and strengthen access to affordable vision correction. Most importantly, it would align India’s regulatory framework with WHO SPECS 2030 and the WHO recognition of spectacles as essential assistive products and be in line with the Govt of India objective.
India has an opportunity to create a balanced regulatory framework that protects consumers while ensuring that essential assistive products remain accessible and affordable. Distinguishing mass-manufactured products from custom-manufactured prescription spectacles would represent an important step towards achieving universal eye health and strengthening India’s leadership in vision care.
The above views expressed by Ramachandran Parthasarathy are in his personal capacity.
Ramachandran Parthasarathy
Eyewear Consultant
Eyewear Business Strategy Expert South Asia
Honorary Advisor – India Vision Institute
