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MTaI urges CDSCO to provide extension for implementation of sales registration requirements for contact lens sellers

Our Bureau, New Delhi
Wednesday, October 12, 2022, 14:45 Hrs  [IST]

While welcoming the drug regulator’s move to simplify sale licence requirements for retailers and wholesalers of medical devices, the Medical Technology Association of India (MTaI), which represents leading research-based medical technology companies with significant investments in manufacturing, raised concerns regarding the on-ground implementation of the registration on contact lens traders.

The Association requested the Central Drugs Standard Control Organisation (CDSCO) to urgently provide extension for the implementation of sale license or registration certificate requirements for contact lenses and lens care products.

The Association welcomed CDSCO notice GSR 754 (E) simplifying sale license requirements for retailers and wholesalers who are involved in stock or sale of medical devices by also allowing registration certificates in its lieu.

The association, which represents a significant portion of the contact lens industry, also pointed out that the simplified sale license requirements are well intended but expressed concerns regarding their on-ground implementation.

Pavan Choudary, chairman & director general, MTaI, said, “Contact lenses & lens care products are being sold for several decades in the country outside of a sale license requirement in optical stores and contact lens clinics. The new sales license rules, though welcome, would mean that thousands of these optical shops now need to go through this mechanism for registration. Most of these units are not aware of the sales license requirement and the process to get the registration certificate. This has disrupted the contact lens business.”

Some of the hurdles the implementation of the registration has to face include lack of awareness among optical stores and contact lens clinics regarding sale license/ registration certification requirements, lack of preparedness among the regulators for implementation of due process, and factors such as several State Licensing Authorities, zone officers and other relevant authorities are yet to be fully sensitised to this registration certificate requirement.

“The prescribed process which requires uploading of registration forms is not currently available on the portal nor does it have in place an uploading mechanism,” he added.

There are challenges related to submission of application due to wide geographical spread of optical stores and contact lens clinics across the country, in absence of an online mechanism to apply for registration, the retailers in upcountry/smaller towns will have to travel to their respective State Licensing Authority (SLA) where authorities may not be ready to receive it or process the additional load.

“MTaI has apprised the Central Drugs Standard Control Organization regarding these issues and look forward to their urgent intervention for a resolution of the same,” added Choudary.

Sanjay Bhutani, managing director, Bausch & Lomb India, said, “The most impacted will be the youngsters with active lifestyles who rely on contact lenses for their day-to-day activities.”

He added that there are more than twenty thousand powers in contact lens based on physiology of the eye, 95% of these powers are not stocked by retail stores and optometrists. As a practice, the retail store orders the required power from the distributors and provides it to the patient.

“With the new registration/sales license process in effect from October 1, the optical stores are already facing challenges as they are unable to provide contact lenses to patients. The implications of regulations will be even more for the patients with ‘Astigmatism’ who require toric-lenses,” added Bhutani.

“Till the mechanism is ready for implementation of GSR 754 (E), we request the CDSCO to urgently provide extension for the implementation of sale license or registration certificate requirements for contact lenses and lens care products. As most of the optical shops and contact lens clinic are included in the registration process for the first time, they need sufficient time to understand the regulations and take the necessary approvals. Therefore, a transition time of 5-6 months should be provided to ensure smooth compliance”, he maintained.

 

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