Lok Sabha Question No. 179 (STARRED), answered on 2019-11-29
Subject: National Essential Diagnostics List
Ministry: HEALTH AND FAMILY WELFARE
Asked by: Dayakar Pasunoori, Venkatesh Netha Borlakunta

## GOVERNMENT OF INDIA MINISTRY OF HEALTH AND FAMILY WELFARE DEPARTMENT OF HEALTH AND FAMILY WELFARE

## LOK SABHA STARRED QUESTION NO . 179 TO BE ANSWERED ON THE 29 TH NOVEMBER , 2019 NATIONAL ESSENTIAL D IAGNOSTICS LIST

## *179. SHRI PASUNOORI DAYAKAR: SHRI VENKATESH NETHA BORLAKUNTA:

Will the Minister of HEALTH AND FAMILY WELFARE be pleased to state:

- (a)  whether  the  country  has  got  its  first  National  Essential  Diagnosti (NEDL) by ICMR which aims to bridge the current regulatory sys tem's gap that do not cover all the medical devices and in - vitro diagnostic device;
- (b) if so, the details thereof along with the views of general public and this regard;
- (c) whether it is a fact that while affordability of diagnostics is a prime countries like India, low cost, inaccurate diagnostics have made their way Indian market which could adversely affect the quality of healthcare system, t he details thereof and the reaction of the Government thereto; and
- (d) whether implementation of NEDL would enable improved healthcare service delivery  through  evidence - based  care,  improved  patient  outcomes,  reduction  in out - of - pocket expenditure, effec tive utilisation of public health facilities, effe assessment of disease burden, disease trends, surveillance/outbreak identif and  address  antimicrobial  resistance  crisis,  if  so,  the  details  thereof  a yielded so far?

## ANSWER THE MINISTER OF HEALTH AND FAMILY WELFARE (DR. HARSH VARDHAN)

- (a)to (d ):A statement is laid on the Table of the House

## STATEMENT REFERRED TO IN REPLY TO LOK SABHA STARRED QUESTION NO. 179* FOR 29 TH NOVEMBER , 2019

(a)to(d) The Free Diagnostics Service Initiative (FDI) was rolled out under t of National health Mission in July, 2015. It encompasses three components -Free Laboratory services; Free Teleradiology Services and Free CT scan services. Essential Diagnostics list mandating the provision of identified diagnostic serv different  level  of  public  healthcare  institutions  was  notified  under  NHM  i 2015. The EDL is reviewed and revised from time to time. Recently, the Guida document  for  imp lementing  Free  Laboratory  services  has  been  released  to States/UTs in July 2019 and the EDL has been expanded. The notified EDL unde NHM provide for 134 tests at District Hospital, 111 tests at Sub District Hosp tests at Community Health Centre, 6 3 tests at Primary Health Centre and Ayushman Bharat Health & Wellness Centre -PHCs; and 14 tests at Sub Centre and Ayushman Bharat  Health  &  Wellness  Centre -Sub  Health  Centre.  The  tests  are  identified keeping  in  view  the  needs  for  providing  comprehensiv e  Primary  Health  Care inclusive  of  Reproductive  &  Child  Health,  control  of  communicable  and  No Communicable  diseases,  specially  related  to  National  programmes  and  Initiat implemented under NHM.

The  National  Essential  Diagnostics  List  (NEDL) , published  by  ICMR , builds upon the Free Diagnostics Service Initiative of NHM and suggests the essential diagnostics tests to be performed at each facility level.  The NE public domain and available h attps://www.icmr.nic.in/sites/default /files/guidelines/NEDL\_2019.pdf .

The draft ICMR -NEDL was put up for public comments on December 14, 2018.  The  comments  and  suggestions  were  received  from  pharma associations, NGOs, diagnostic manufacturing companies, and independent experts. The comments/suggestions  are  indicated  as  per  Annexure.    The  suggestions  recei were  discussed  with  the  expert  group  comprising  of  representatives  of  nat program (TB, M alaria, HIV/AIDS, Hepatitis, Non - Communicable Diseases), NHSRC and experts (clinicians, microbiologists and pathologists). The suggest approved by the group were incorporated in the final NEDL document.

The  In  Vitro  Diagnostics  are  regulated  under  Drug s  and  Cosmetics  Act, 1945  and  Medical  Devices  Rules,  2017  for  their  manufacture,  import,  sale distribution.  Before placing any In Vitro Diagnostics in the market ,it has to comply with the various regulatory requirements like submission of data pertai ning to its development,  manufacturing,  quality,  stability,  performance,  testing  and  q management system under which it is produced.  Accordingly, there are regula measures  to  safeguard  the  quality  of  In  Vitro  Diagnostics.    The  manufactu importers  and  distributors  who  do  not  comply  with  these  requirements punishable  under  the  Drugs  and  Cosmetics  Act,  1940.  No  reports  that  low  c inaccurate  diagnostics  have  made  their  way  into  the  Indian  market  which  c adversely affect the quality he althcare system have been received in Central Drugs Standard Control Organization (CDSCO).

The EDL notified under NHM is comprehensive and includes suggestions contained  in  NEDL  of  ICMR.  The  implementation  of  Free  Diagnostics  Service Initiative  aims  at  r educing  Out  of  Pocket  Expenditure  and  ensuring  quality diagnostics services.

## Annexure

## Comments received from general public and experts

- National  EDL  should  be  strategic,  realistic  and  address  the demands of our country.
- Ability to deliver at multiple levels of health care, with a fo primary health care, is a very important criterion for the nationa

and

- The list should have tests for both communicable -communicable diseases (NCDs), complimenting the nationa l vertical health programmes.

non

- NEDL  should  be  small,  simple,  robust,  relevant  and  affordable society.
- It should provide guidance on logistics and infrastructure, mainta quality and supply chain.
- There  is  a  need  to  build  capacities  of  service  prov iders  in  guiding patients  which  facilities  offer  what  diagnostics  tests,  collect samples at spokes and transport of samples to hubs.
- National  EDL  should  ensure  minimal  movement  of  patient  across facilities and providers.
- An innovative research in d iagnostics related to our priority healthcar conditions was emphasized.
- Assay formats need to be discussed for cost - effectiveness considerations.
- Innovations are needed to bridge gap between rapid test and cent laboratory tests.
- The  necessity  of  poi nt - of - care  tests  for  common  pathogens  was emphasized.
- Inclusion  of  culture  facilities  in  the  list  specifically  for  q healthcare and antimicrobial resistance was highly recommended.

are

- There is a need to ensure quality of products and tests for diag no i -a well defined  in - house  validation and evaluation criteria important.