The Association of Indian Medical Device Industry (AiMeD), the umbrella association of Indian manufacturers of medical devices, has once again appealed to the Union ministry for health and family welfare (MoHFW) to bring in a separate simple, implementable regulation for medical devices to encourage the growth of domestic industry and reduce the 80 per cent import dependence. In its suggestions and response to the Draft New Drugs, Medical Devices and Cosmetics Bill, 2022, the Association also reiterated its demand to remove provisions for punitive and criminal judicial action against some of the offences by the manufacturers, proposed in the draft Bill. “While appreciating the intent of MOH&FW and Authors of the Bill to regulate all Devices appropriately and to bring in reforms, the objective is not being met,” said Rajiv Nath, forum coordinator, AiMeD. “We regret to note that instead of proposing an independent Medical Device Regulations and Patient Safety Bill, a combined complex Bill for Regulating Drugs, Medical Devices and Cosmetics has been proposed which again treat Devices as Drugs as in Drugs & Cosmetics Act with most punitive action of treating an errant Manufacturer as being criminal. This is fundamentally incorrect and a non starter in case of Medical Devices,” he added. The Association strongly recommended once again for a separate simple, implementable regulation for Medical Devices if ‘Make in India’ of Medical Devices is to be encouraged and if government is keen to address the ongoing 80% import dependence. The law needs to be ‘civil’ in nature as is case of FSSAI regulations or under International Medical Device Regulations as by Canada, which no more seeks imprisonment for offences and for most short coming/errors do not treat manufacturers as a criminal as making these Devices are as an engineering product and not like making pharmaceutical medicines. Medical devices are not drugs and in past a few of them have been attempted to be incorrectly regulated as Drugs under Drug Rules and Drugs Act until 2017 when Medical Devices Rules were introduced that recognized the need for separate Regulatory Controls but even these Rules were put under the antiquated Drugs Act. One major reason for the import dependency is the shift from manufacturing to more convenient and cheaper import based trading activity leading to Pseudo Manufacturing whereby the entity instead of calling himself marketing company still labels products as “Manufacture by” incorrectly and the Association has raised its apprehension that now the revised definition of manufacturer will legally permit him to do so. The MoHFW instead of supporting and contribution to improving on the Medical Device (Safety, Effectiveness and Innovation) Bill 2019 proposed by NITI Aayog set up a Committee of Regulators to draft a New Bill to regulate Devices as Drugs as a Compulsory Regulation but is still having the old mindset approach of treating manufacturers as criminals rather than seeking preventive steps of enforcing quality management system and quality assurance and seeking progressive improvement in implementation and enforcement to ensure public safety which not being a bottleneck of access to affordable innovations. “While the NITI Aayog Bill focus was on innovative medical devices this has ‘No’ mention in the proposed DMDC Bill 2022,” said the Association. It added that the proposed Bill must ensure public safety but not throttle investments or kill existing SME’s making medical devices. The punitive and criminal judicial action may be maintained only for any non licensed or non registered manufacturing facility of medical devices and manufacturer who has not even applied for registration/licensing compliance. Any person who is a regulated/licensed manufacturer/exporter/importer/reseller of Medical Device is to be considered as willing to subject himself to conformity assessment and abide with prescribed regulations and regulatory process and needs to be disciplined by the regulatory authority through an administrative process, to strive for improvements in quality, consistency and patient safety. This willingness to abide and be disciplined can be part of the licensing procedures as an undertaking. Reliance needs to be of correction and improvement of processes and controls at the manufactures/logistics/warehousing/retailing/final utilization for ensuring patient safety through administrative methods before using the judiciary which is already overburdened with pending cases. “The regulatory authority should have administrative powers for putting things right in a progressive manner added to risk proportionate regulatory controls e.g. Show Cause Notice, warning. Recall of goods, field corrective action, levying a fine, suspension of license etc. if it’s a mislabeling issue e.g. mismatching of a letter of a batch no. of a unit pack or shelf box it should not warrant jail terms for managing directors! You do not need to kill a fly with a machine gun. This will discourage Make in India and innovate in India,” it added. Similarly the concept of having a Central Medical Device Testing Centre as a corresponding equivalent to a Central Drug Laboratory as an Apex all inclusive Testing Centre is questionable. There are over 6,000 medical devices and depending upon the material science or stream of Scientific & testing expertise a limited range of devices can usually be tested at a centre of excellence but wishing to consider one national laboratory at a single location to do biocompatibility testing, animal studies & testing, mechanical & chemical testing or electronic component & product testing will be overly ambitious and may not be practical. Regulatory controls need to be split and shared between Centre, State and Conformity Assessment Notified Bodies but in the Bill the industry has noticed that no such clear lines or directions but continuity of earlier system of duplication of State and Central Government Regulations and no accountability of a State Regulator to the Central Licensing Authority or a National Regulator which lead to non harmonious enforcement. While onus is on Manufacturer the onus of competency of Regulatory Officer is not defined nor of the user. Law should also clarify Role of Regulator in supervision of the Conformity Assessment Bodies, it added. SOURCE: PHARMABIZ
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