Industry appreciates CDSCO notice to address issues but appeals to authorities to ensure proper mechanism and transition time to comply
Medical Technology Association of India (MTaI) has welcomed the Central Drugs Standard Control Organization (CDSCO) notice GSR 754 (E) simplifying sale license requirementsfor retailers and wholesalers who are involved in stock or sale of medical devices by also allowing registration certificate 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”.
“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”, appealed Sanjay Bhutani, Managing Director, Bausch & Lomb India.