New Delhi : The Drugs Controller General (India) has asked the State drug controllers to ensure uninterrupted supply of medical devices even as it is considering the medical devices industry’s request regarding relaxation on the deadlines for the registration of the products with the authority. The move comes closer to the initiation of compulsory registration regime for the Class A & B medical devices in the country, which will be starting from October.
The Central Drugs Standard Control Organisation (CDSCO) has also announced classification of 48 medical devices pertaining to Oncology, 153 devices related to gastroenterology, and another 110 related to neurological therapy.
According to the ministry of health and family welfare’s notification on February 11, 2020, the medical devices were under voluntary registration scheme from April 1, 2020 till end of September, 2021. From October 1, 2021, Class A & B Medical Devices will be under compulsory registration scheme up to September, 2022 and Class C & D medical devices will be under compulsory registration scheme up to September 2023. After the compulsory registration period, these classes will respectively move to the licensing regime.
However, the ministry has received various representations from stakeholders recently informing that complete preparedness of industry in this regard remains to be achieved, in light of disruption due to Covid-19 pandemic situation.
“The representations are under consideration of the ministry of health and family welfare, Government of India. You are requested to take note of the same with a view to ensure uninterrupted supply of such medical devices and access to the patients till a decision is taken on the representations,” said a letter from Dr V G Somani, Drugs Controller General (India) to all drug controllers.
The industry has raised concerns on the regulation moving to a compulsory registration regime from October, this year, since there are companies yet to register their products. The CDSCO has also published the list of eight notified bodies registered with the Organisation under the Medical Devices Rule, 2017, to carry out audits of manufacturing sites under the provisions of the said rules.
Rajiv Nath, forum coordinator, Association of Indian Medical Device Industry (AiMeD), in a recent conference said that many manufacturers don’t have the ISO/IS 13485 certification, which is a requirement for registration of the medical devices. Many of them are feeling challenged to get the certification, especially in Covid-19 times and the industry is seeking certain concessions from the government on that.
“Our request is that all Class A non sterile products can be asked to fulfill a simple checklist. For instance, the surgical instruments manufacturers are challenged, they can give a self declaration form and undertake that in one year’s time they will achieve ISO 9000 certification and on that basis they can be registered. We need not delay registration, we can still go forward, but based on an undertaking,” he said.
“Similarly, in Class A sterile, Class B, C and D, if people have ISO/IS 13485 that is good, if they don’t they may be asked to submit an undertaking that they will achieve this in one year’s time and they can be taken forward for registration. It is important that the certification comes from the National Accreditation Board for Certification Bodies (NABCB) or an International Accreditation Forum (IAF) accredited certification body, in order to avoid any fake or unrecognised certification,” he added.
On October 18, certain implants and seven electronic medical devices are going to be regulated and put under manufacturing license. But there is still no conformity assessment ecosystem in the country for the manufacturers to prove compliance. Test laboratories are still not there, and the industry and the regulator need to discuss that.
“We request that a nine months’ transition period be provided to achieve the manufacturing license, to August 2023. Meanwhile, if somebody is ready with these products, give them the license. We seek a nine month transition period to switch the packaging material also, to put the registration number on packaging material. In certain cases the packaging needs to be changed,” maintained Nath.
The CDSCO, industry and other stakeholders need to work together to build competence of auditors, medical devices officers and manufacturers in the MSME levels. There should be clarity on the testing laboratories, for each product family. Government can look at incentivising private laboratories to provide testing services. When QCI’s voluntary QA certification is available with manufacturers, both Indian and Overseas, then there should be reduced regulatory oversight for all the four classes of medical devices. There is also a need to expedite adoption of ISO standards and BIS standards, he said.
