**Executive Summary**
The document is a response to a question in Lok Sabha regarding the quality of eyeglasses and optical lenses in India. It outlines the regulatory mechanisms instituted by the Ministry of Health and Family Welfare through the Medical Devices Rules, 2017, effective from January 1, 2018. These rules provide comprehensive regulations for the import, manufacture, sale, and distribution of medical devices, including eyeglasses and optical lenses.
**Key Points / Main Content**
* **Regulatory Framework:**
* Medical Devices Rules, 2017, notified under the Drugs and Cosmetics Act, 1940, govern the import, manufacture, sale, and distribution of medical devices.
* The rules are effective from January 1, 2018.
* **Regulatory Authorities:**
* The Central Drugs Standard Control Organization (CDSCO) regulates the import of all classes of medical devices (A, B, C, and D) and the manufacture of Class C and D medical devices.
* State Licensing Authorities (SLAs) regulate the manufacture of Class A and B medical devices, based on conformity assessment by a registered notified body.
* SLAs also regulate the sale and distribution of all classes of medical devices.
* **Testing and Standards:**
* CDSCO has notified NABL accredited laboratories for testing medical devices.
* Central Medical Device Testing Laboratories are notified by the Government of India for testing.
* Medical devices must conform to standards specified by the Bureau of Indian Standards (BIS) or those notified by the Central Government.
* In the absence of BIS or government standards, devices must comply with ISO, IEC, other recognized pharmacopoeial standard, or the validated manufacturer's standards.
* **Enforcement:**
* Non-compliance can result in suspension or cancellation of licenses and prosecution under the Drugs and Cosmetics Act, 1940, and the Medical Devices Rules, 2017.
**Impact Analysis**
**Stakeholder: Manufacturers of Eyeglasses and Optical Lenses**
* **Impact:** Must comply with the Medical Devices Rules, 2017, for manufacture, import, sale and distribution. They are subject to regulatory oversight by CDSCO and SLAs depending on device class.
* **Action Required:** Ensure conformity with BIS or equivalent standards. Undergo assessment and obtain licenses.
**Stakeholder: Importers of Eyeglasses and Optical Lenses**
* **Impact:** Must comply with the Medical Devices Rules, 2017, for import. Subject to regulatory oversight by CDSCO depending on device class.
* **Action Required:** Obtain necessary licenses.
**Stakeholder: Distributors and Sellers of Eyeglasses and Optical Lenses**
* **Impact:** Must comply with the Medical Devices Rules, 2017, for sale and distribution. Subject to regulatory oversight by SLAs depending on device class.
* **Action Required:** Obtain licenses and adhere to relevant regulations.
**Stakeholder: Consumers**
* **Impact:** Assured quality of eyeglasses and optical lenses due to regulatory mechanisms and standards.
* **Action Required:** None explicitly stated.
Key Entities Referenced
Medical Devices Rules, 2017: Rules notified by the Ministry of Health & Family Welfare under the Drugs and Cosmetics Act, 1940 to regulate medical devices.
Drugs and Cosmetics Act, 1940: The principal act under which the Medical Devices Rules, 2017 are enacted.
Ministry of Health and Family Welfare: The ministry responsible for regulating medical devices and related standards.
CDSCO: Central Drugs Standard Control Organisation, the regulator for import of all classes of medical devices and manufacture of class C & D medical devices
Bureau of Indian Standards (BIS): The national standards body of India, responsible for specifying standards for medical devices
GOVERNMENTOFINDIA
MINISTRYOFHEALTH AND FAMILYWELFARE
DEPARTMENTOFHEALTH AND FAMILYWELFARE
LOK SABHA
UNSTARREDQUESTION NO. 2429
TO BE ANSWERED ON13THFEBRUARY, 2026
QUALITYOFEYEGLASSESAND OPTICALLENSES
2429.SHRIPARSHOTTAMBHAI RUPALA:
Will the Ministerof HEALTH AND FAMILYWELFAREbe pleasedtostate:
(a) whether the Government has instituted/proposes to institute a regulatory mechanism to
periodically test, certify and monitor the quality of eyeglasses and optical lenses in the
country, if so, the detailsthereof;
(b) whether the Government is aware that substandard eyeglasses and lenses are adversely
affecting the vision of the people inthe countryandif so, the details thereof;
(c) whether the Government has examined international practices and foreign legislation that
have established optical councilsor regulatorybodiesfor enforcingqualitystandards; and
(d) if so, the details thereof along with the key elements identified from such legislations for
possible adoptioninthe country?
ANSWER
THE MINISTER OFSTATE IN THE MINISTRYOFHEALTH AND FAMILY
WELFARE
(SMT.ANUPRIYAPATEL)
(a)to(d): To have a comprehensive regulatory provisions for import, manufacture, sale
and distribution of all medical devices including prescription spectacles, contact lenses and
intraocular lenses, based on risk based criteria, the Ministry of Health & Family Welfare,
Government of India has notified the Medical Devices Rules, 2017 vide G.S.R. 78(E) dated
31.01.2017 under the provisions of the Drugs and Cosmetics Act, 1940. Said rules are
effective from 01.01.2018to regulate the clinical investigation,manufacture, import,sale and
distribution of the medical devicesinthe country.
Under the rules, the import of all classes of medical devices (Class A, B, C, and D)
andthe manufacture of Class C and D medicaldevices are regulated by CDSCO, whereas the
manufacture of Class Aand B medical devices is regulated by the concerned State Licensing
Authorities (SLAs) after conformity assessment by a registered notified body. The sale and
distribution of all classes of medical devices are regulated by the SLAs. CDSCO has notified
NABL accredited laboratories for testing of medical devices on behalf of manufacturers and
Central Medical Device Testing Laboratories are notified by Government of India for testingof medical devices. In the event of non-compliance, appropriate actions including suspension
or cancellation of licenses and prosecution initiated as per the provisions of the said Act and
Rules.
Under MDR 2017, the medical devices are requiredto conform to standards specified
by the Bureau of Indian Standards (BIS) or those notified by the Central Government. In the
absence of such standards, devices must comply with standards of the International
Organization forStandardization (ISO),the InternationalElectrotechnicalCommission (IEC),
or other recognized pharmacopoeial standard or the validated manufacturer’s standards,
wherever applicable.
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