Friday, November 16, 2018

Request of HCFI for formulation of law relating to national essential devices and disposables in India has been accepted by the central government




Dr KK Aggarwal & Advocate Ira Gupta

Heart Care Foundation of India (HCFI) had filed one RTI Application dated 22.01.2018 with National Pharmaceutical Pricing Authority, Department of Pharmaceuticals and also with Drug Controller General of India, Ministry of Health and Family Welfare asking them to provide following information:

1.           Is there any law relating to National Essential Medicine in India? If yes, please provide the details of the said law.
2.           Is there any policy of Ministry of Health relating to National Essential Medicine? If yes, please provide the copy of the said policy.
3.           Is there any list of National Essential Medicine in India? If yes, please provide the copy of the said list.

In response to the said RTI application dated 22.01.2018, the Ministry of Health and Family Welfare had given its reply dated 09.02.2018 wherein the Ministry of Health and Family Welfare had specifically stated that there is no separate list of National Essential Devices and Disposables and that the Ministry of Health & Family Welfare only issues the National List of Essential Medicines. The relevant portion of the reply dated 09.02.2018 is reproduced hereunder:

“Reference is invited to your RTI application dated 22.01.2018 forwarded by Shri Arun Kumar Diwan, CPIO, NPPA vide letter No. 23011/07(1)/16-Admn/NPPA-RTI/Pt.-I dated 24.01.2018 (received on 31.01.2018) and it is informed that there is no separate list of National Essential Devices and Disposables. Ministry of Health & Family Welfare issues only the National List of Essential Medicines (NLEM).”

Thereafter, the Directorate General of Health Services, Office of DCG (I) had also sent a reply dated 20.02.2018 thereby informing that they do not have any information relating to National Essential Devices and Disposables.

Thereafter, HCFI submitted one representation dated 08.06.2018 to Mr. Narendra Modi, Hon’ble Prime Minister of India, Mr. Jagat Prakash Nadda, Hon’ble Minister of Ministry of Health & Family Welfare and also to Mr. Ravi Shankar, Hon’ble Minister of Ministry of Law & Justice thereby requesting them to recognise and prepare the List of National Essential Devices and Disposables in the same manner as National List of Essential Medicines is being recognised and prepared.

The request of HCFI of formulation of law relating to National Essential Devices and Disposables in India is duly accepted by Hon’ble Ministers and accordingly, vide letter dated 07.08.2018, the Drug Controller General, Central Drugs Standard Control Organization, DGHS informed HCFI that Ministry of Health and Family Welfare has constituted as committee for preparing detailed guidelines and procedures for revision of National List of Essential Medicines and inclusion of Medical devices, Medical Disposables and Medical Consumables and other products used for Health and Hygiene of general public in NLEM.  The relevant portion of the letter dated 07.08.2018 is reproduced hereunder:

This office has received a representation vide PMO ID No. PMOPG/D/2018/021845 enclosing your letter dated 08.06.2018 for taking appropriate action on the subject mentioned above.

In this regard, it is pertinent to mention here that Ministry of Health and Family Welfare vide F. No. 11053/923/2017-DRS dated 03.07.2018 has constituted a Standing National Committee on Medicines (SNCM) under the Chairmanship of Secretary, DHR and DG, ICMR.
           
As per the Term of reference of the SNCM, the committee will prepare detailed guidelines and procedures for revision of National List of Essential Medicines and suggest additions and deletion in the NLEM, Revision of NLEM 2-15, Inclusion of Medical Devices, Medical Disposables, Medical Consumables and other product used for Health and Hygiene of general public in NLEM.

It is important to mention herein that across the world, the National Essential Devices and Disposables is being recognised by law and which are as important as a National List of Essential Medicines. Now, after the constitution of the said Standing National Committee on Medicines, in India also there will be National List of Essential Medical Devices, Medical Disposables Medical Consumables and other product used for Health and Hygiene of general public in NLEM.

The National List of Medical Devices, Medical Disposables, Medical Consumables and other products used for Health and Hygiene will be beneficial for the general public for the following reasons:

·         Guide safe and effective treatment of priority disease conditions of a population
·         Promote the rational use of Medical Devices, Medical Disposables, Medical Consumables and other products used for health and hygiene.
·         Optimize the available health resources of a country
·         State governments can use this national list as a guide to prepare their list of essential Medical Devices, Medical Disposables, Medical Consumables and other products used for health and hygiene
·         There will be uniformity in prices of Medical Devices, Medical Disposables, Medical Consumables and other products used for health and hygiene included in the national essential list.

Dr KK Aggarwal
Padma Shri Awardee
President Elect Confederation of Medical Associations in Asia and Oceania   (CMAAO)
Group Editor-in-Chief IJCP Publications
President Heart Care Foundation of India
Immediate Past National President IMA

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