MINISTRY OF HEALTH AND FAMILY WELFARE RELEASES DRAFT GUIDELINES FOR MEDICAL DIAGNOSTIC LABORATORIES IN THE COUNTRY

MINISTRY OF HEALTH AND FAMILY WELFARE (Department of Health and Family Welfare) NOTIFICATION – New Delhi, the 5th May, 2017

Central Govt proposes to introduce new rules called the Clinical Establishments (Central Government) Amendment Rules, 2017 by defining Minimum Standards for diagnosis or treatment of diseases. These rules are drafted by the Govt after consultation with the National Council for Clinical Establishments in the country.

Every clinical establishment relating to diagnosis or treatment of diseases where pathological, bacteriological, genetic, radiological, chemical, biological investigations or other diagnostic or investigative services, are usually carried on with the aid of laboratory or other medical equipment, shall comply with the minimum standards of facilities and services as specified in the Rules.

Draft rules clearly defined the following :

– classification of laboratories based on their size;

– infrastructure specification for these labs;

– Scope of services that can be offered by these labs;

– mandatory human resource requirements for these labs,

– Minimum requirements on usage of equipments, instruments, consumables in labs

– Legal and Statutory compliances

– Record Keeping Guidelines

– basic systems and processes that should be followed by these labs in the country to be eligible    for licensing and registration of the labs.

Above guidelines are released by MoH as draft guidelines on May 5, 2017 and same are open for public comments.

Objections and suggestions, if any, on the above guidelines may be addressed to

The Under Secretary (Medical Services),

Ministry of Health and Family Welfare,

Government of India,

Room No. 508, D Wing, Nirman Bhavan, New Delhi – 110011

or send email to sunil.kumar20@gov.in

Draft guidelines are published for information of all persons likely to be affected thereby and notice is hereby given that the said draft rules will be taken into consideration on or after the expiry of a period of forty-five days from the date on which copies of the Gazette of India containing these draft rules are made available to the public.

Objections and suggestions which may be received from any person within the period specified above will be considered by the Central Government.

Click here for the full announcement :

Minimum Standards for Medical Labs – Clinical Establishments Act

Training Programs for the month of April 2017

Team Value Added is conducting the following Training programs in April 2017.

 

Training Program on New Medical Devices Rules 2017 on  April 20, 2017, between 10 am to  1 pm @ Andhra Chamber of Commerce, “Velagapudi Ramakrishna Building”, 23 Third Cross Street, West CIT Nagar, Nandanam, Chennai – 600 035

Training is conducted by Dr.G.S.Bhuvaneshwar who has got more than 3 decades of experience in Medical Devices Design, Development, Testing and Quality Management

Training focus will be on the

  1. Current Regulations & Systems in Medical Devices
  2. Overview of the New Medical Devices Rules 2017
  3. Applicable regulations for Manufacturers, Dealers, Distributors, Importers etc

Please click here for Training brochure

Please click here for Registration form

 

NABL 112 – Specific Criteria on Accreditation of Medical Laboratories – April 22nd 2017 between 9.30 am to 1 pm @ Andhra Chamber of Commerce, “Velagapudi Ramakrishna Building”, 23 Third Cross Street, West CIT Nagar, Nandanam, Chennai – 600 035

 

NABL has revised the specific criteria document recently based on ISO 15189:2012 standard requirements. The new document comes into effect from 1st July 2017.

This new NABL 112 document supersedes the NABL 112 3rd Issue. All Medical Laboratories either applying for accreditation from now on or NABL applicant laboratories & laboratories awaiting surveillance or recertification assessment are to conform to this new NABL 112 document requirements

A sensitization & Awareness session on the recently released NABL 112 – specific criteria on Accreditation of Medical Laboratories by Dr.V.K.Ramadesikan

Please click here for Training brochure

Please click here for Registration form

 

Please go through the Training brochures and send us your nominations to padma@valueadded.in or info@valueadded.in.

Call us @ 24462337 / 24462338 to confirm your participation in the above training programs.

Workshop on GCLP (Good Clinical Laboratory Practices) on International Standards (ISO 15189:2012) @ Chennai

YRG Centre for AIDS Research and Education (YRG CARE), Chennai & Sri Ramachandra University, Chennai is organizing a workshop on GCLP (Good Clinical Laboratory Practices)  on International Standards  (ISO 15189:2012) @ Chennai.

Program Details are given below:

Organized by: YRG Centre for AIDS Research and Education (YRG CARE), Chennai & Sri Ramachandra University, Chennai

Dates: 23-25, March 2017

Venue: Harvard Auditorium, Sri Ramachandra University, Chennai

Download Brochure and Registration form HERE

Contact Info: Email: gclp@yrgcare.org

IRDA MANDATES HOSPITALS ON NABH ACCREDITATION

INSURANCE REGULATORY AND DEVELOPMENT AUTHORITY OF INDIA

NOTIFICATION

Hyderabad, the 12th July, 2016
Insurance Regulatory and Development Authority of India (Health Insurance) Regulations, 2016 

“All such providers offering cashless services for allopathic treatment shall meet with the preaccreditation entry level standards laid down by National Accreditation Board for Hospitals (NABH) or such other standards or requirements as may be specified by the Authority from time to time within a period of two years from the date of notification of these Guidelines. (Explanatory Note: Network Providers are to visit NABH website for details regarding procedure for obtaining the necessary accreditation)”

Ref notification: IRDA/HLT/REG/CIR/146/07/2016 dated 29.07.2016

Click here to see Notification