The Bureau of Indian Standards (BIS), through the Department of Pharmaceuticals, is in the process of finalising a quality-control mechanism for medical devices and has issued a draft Quality Control Orders (QCO) for six categories of devices, including blood glucose monitoring system, surgical blades and gloves, seeking stakeholder views.
Though welcoming the move, the Medical Technology Association of India (MTAI), which represents research-based medical technology companies, has noted that the QCO “doesn’t fit in government’s broader plan to ensure patient safety or lower cost of healthcare.”
In a statement, the group said the proposed QCO has a limited scope as it does not adequately address all aspects of quality, safety and performance and only covers the product safety standard of medical devices. “Conforming to the order would mean increase in compliance cost for companies that are already adhering to essential checklist requirements of the Central Drugs Standard Control Organisation (CDSCO) and other global standards for domestic companies looking to export, since products must first conform with BIS standards, then qualify for global standards, etc. for eligibility for global markets,” said Pavan Choudary, chairman, MTAI.
CDSCO has started the process to regulate all medical devices under the Drugs & Cosmetic Act as well as under the provisions of newly-introduced Medical Device Rules 2017, in a phased manner. “Currently only 37 medical devices are regulated and CDSCO has proposed a regulatory road map which aims at bringing all categories of medical devices under regulation... over a span of 4-5 years,’’ said a senior health official.
He added that as per the roadmap, all devices needs to be registered with CDSCO in the first phase of 12-18 months and then detailed due diligence of the devices will be carried out in the next 2-3 years. The proposal has already been approved by the Drug Technical Advisory Board (DTAB) which is the highest statutory decision-making body on technical matters related to Drugs in the country.
“There is duplication in what CDSCO and the QCO seeks to do which will lead to multiplicity of authorities as well as increase red tape for medical devices. While our demand for having a separate Act for regulation of medical device remain, we feel CDSCO should continue taking the lead in regulating the sector as it has the maximum expertise and experience in governing the medical device universe,” MTaI statement added.
