16-Aug-2019: India gets its first national essential diagnostics list
India has got its first National Essential Diagnostics List (NEDL) finalised by the Indian Council of Medical Research (ICMR) which aims to bridge the current regulatory system’s gap that do not cover all the medical devices and in-vitro diagnostic device (IVD). The current system is equipped to manage only the few notified devices.
With this, India has become the first country to compile such a list that would provide guidance to the government for deciding the kind of diagnostic tests that different healthcare facilities in villages and remote areas require. The list is meant for facilities from village till the district level.
WHO released first edition of essential diagnostics list (EDL) in May 2018. Even though WHO’s EDL acts as a reference point for development of national EDL, India’s diagnostics list has been customised and prepared as per landscape of India’s health care priorities.
NEDL builds upon the Free Diagnostics Service Initiative and other diagnostics initiatives of the Health Ministry to provide an expanded basket of tests at different levels of the public health system, explained a senior ICMR official.
He said implementation of NEDL would enable improved health care services delivery through evidence-based care, improved patient outcomes and reduction in out-of-pocket expenditure; effective utilisation of public health facilities; effective assessment of disease burden, disease trends, surveillance, and outbreak identification; and address antimicrobial resistance crisis too.
While affordability of diagnostics is a prime concern in low, middle-income countries like India, low cost, inaccurate diagnostics have made their way into the Indian market which has no place in the quality health care system.
The list also encompasses tests relevant for new programmes such as Health and Wellness Centres (HWCs) under the Pradhan Mantri Jan Arogya Yojana. In addition to tests, corresponding IVD products have also been recommended.
Diagnostics serve a key role in improving health and quality of life and the ICMR has noted that the key challenges anticipated during implementation of the National EDL include — Adoption by States and harmonisation with local standard diagnostic protocols and treatment guidelines, provision of requisite infrastructure, processes and human resources, ensuring quality of tests including EQAS and quality control and adequate utilisation of EDL tests for making informed decisions for treatment protocols.
In India, diagnostics (medical devices and in vitro diagnostics) follow a regulatory framework based on the drug regulations under the Drugs and Cosmetics Act, 1940 and Drugs and Cosmetics Rules 1945. Diagnostics are regulated under the regulatory provisions of the Medical Device Rules, 2017.
21-Apr-2019: Medicine labels in regional language
In order to counter fake, sub-standard and expired drugs, the Union Health Ministry has said Hindi and regional language will be used in the tendering process.
Drug names and expiry date during tendering will be in Hindi/regional language too for — polio drop and Iron tablets — procured for children under the government programmes.
The Drugs Technical Advisory Board (DTAB) recently recommended that government procurement agencies should take necessary steps in the tendering process to include the regional language, along with English, on the label of iron tablets and polio drops in government programmes.
An advisory may be issued by the government. Also a sub-committee may co-opt the representatives from the pharmaceutical manufacturing industry and Indian Pharmaceutical Association for further deliberations on the overall issues related to labelling requirements of drugs.
Since last year, the government has been working on ensuring the most stringent quality control for both the products which directly affect almost all the children born in India.
DTAB, in a meeting held early last year, considered the proposal to amend Rule 96 of the Drugs and Cosmetics Rules, 1945 for labelling of iron tablets and polio drops distributed to the children under government programmes with name and expiry date in Hindi also. The Board then constituted a sub-committee under the chairmanship of Dr. R.N. Tandon, honorary secretary general, IMA, New Delhi to examine and give recommendations to streamline the labelling requirements of drugs so as to provide the requisite information to the consumer.
9-Feb-2019: Medical devices to be treated as drugs
The Centre in a notification said that medical devices — all implantable devices, CT Scan, PET and MRI equipment, defibrillators, dialysis machines and bone marrow separators — will be treated as drugs for human beings with effect from April 1, 2020.
The decision was taken in consultation with the Drugs Technical Advisory Board.
Majority of medical devices are completely unregulated in India. With this move, all implantable devices and some diagnostic equipment will be brought into the regulatory framework which is important from a patient safety perspective.
21-Feb-2019: NABH revamps Entry-Level Certification process for Hospitals
National Accreditation Board for Hospitals and Healthcare Organizations (NABH) has revamped Entry-Level Certification Process to make it simpler, digital, faster and user-friendly. The revised process is driven through a new portal called HOPE - Healthcare Organizations’ Platform for Entry-Level-Certification with a focus to promote quality at nascent stages by enrolling a wide range of hospitals across the country including Healthcare Organizations (HCOs) and Small Healthcare Organizations (SHCOs). The aim is to create a momentum for HCOs and SHCOs that want to avail benefits associated with Insurance Regulatory and Development Authority of India (IRDAI) and Ayushman Bharat by getting themselves NABH certified along with the primary aim of creating a quality healthcare ecosystem in India. The idea of cashless payment to patients under insurance coverage has been promoted by IRDAI to reduce financial burden on households. The IRDAI has mandated hospitals to ensure a quality healthcare ecosystem through NABH Entry-Level Certification Process.
HOPE is not just confined to certification of HCOs/SHCOs but also enables them to comply with quality protocols, improve patient safety and the overall healthcare facility of the organization. It is an online platform for smooth and secure registration. It provides a self-explanatory questionnaire to be filled by the HCO/SHCOs. A mobile application has also been developed to support HCO/SHCOs for directly uploading geotagged and timestamped evidences required for compliance to the standards. It has also changed the assessment process which is now carried out on a technology based application where the data is captured and validated on a real-time basis.
To ensure an active participation of HCO/SHCOs in the HOPE process, various activities have been initiated:
- Nationwide awareness workshops to sensitize the hospitals on the entire process of assessment.
- Call center support to hospitals through an active helpline for resolving issues while filling the application form.
- Platform to connect hospitals with certified consultants for assistance in the certification process following a cost effective manner.
- Knowledge bank providing a comprehensive guidebook, presentation etc. with detailed information of the step-by-step certification procedure.
- Create a larger and stronger network of qualified assessors.
In order to support maximum HCO/SHCOs in the country, QCI and NABH have partnered with several organizations like, Indian Medical Association (IMA), Patient Safety and Access Initiative of India Foundation (PSAIIF), Consortium of Accredited Healthcare Organizations (CAHO) and other stakeholders for spreading awareness about the process.
Established in 1997 Quality Council of India (QCI) is an autonomous organization under the Department for Promotion of Industry and Internal Trade, Ministry of Commerce and Industry. It is the Quality Apex and National Accreditation Body for accreditation and quality promotion in the country. The Council was established to provide a credible, reliable mechanism for third party assessment of products, services and processes which is accepted and recognized globally.
NABH, a constituent body of QCI, has been working to ensure reliability, efficiency and global accreditation in Indian healthcare sector using contemporary methodologies and tools, standards of patient safety and infection control. NABH accreditation provides assurance of quality and care in hospitals at par with international benchmarks. NABH has designed an exhaustive healthcare standard for hospitals and healthcare providers that have been accredited by ISQUA the apex international accreditation body.