PIB – June 27 , 2019


GS-2 Paper

Topic coveredServices relating to Health, Education, Human Resources.

Regulation for Medical Implant Devices

Context

The Standing Committee made certain recommendations for changing the provisions of the Drugs and Cosmetics (Amendment) Bill.

Drugs and Cosmetics (Amendment) Bill

  • The Drugs and Cosmetics (Amendment) Bill was introduced in the Rajya Sabha in.2013.
  • The Drugs and Cosmetics (Amendment) Bill, 2015 was placed in 2016 before the Group of Ministers for consideration.
  • Medical Devices Rules, 2017 were framed and which have become effective from January 1, 2018.
  • All implantable medical devices, CT scan, MRI equipment, defibrillators, dialysis machine, PET equipment, X-ray machine and bone marrow cell separator have been notified as drugs with effect from April 1, 2020.
  • The Central Drugs Standard Control Organization (CDSCO) is the national medical device regulator for its sale and use.

Need for regulation

  • A majority of medical devices are unregulated in India.
  • This move is important for patient’s safety as with this notification, all implantable and diagnostic devices will come under the regulatory framework.
  • The eight medical equipments have been notified as ‘drugs’ under Section 3 of the Drugs and Cosmetics Act, 1940.
  • Companies which are engaged in manufacture and import of these equipment will have to seek necessary permission or license from DCGI from January 1, 2020 onward.
  • All these devices will have to be registered under quality parameters prescribed under Medical Devices Rules, 2017 and other standards set by Bureau of Indian Standard (BIS) certification.
  • This will regulate medical and diagnostics devices in the country.
  • It will create a new regulatory marketing approval system and the government can keep a tab on importers as well as manufacturers.

The Central Drugs Standard Control Organization (CDSCO)

  • The Central Drugs Standard Control Organization (CDSCO) is responsible for approval of licenses of specified categories of drugs such as blood and blood products, vaccines, IV fluids and sera in India.
  • Drugs Controller General of India (DCGI) lays down standards and quality of manufacturing, selling, import and distribution of drugs in India.
  • It acts as appellate authority in case of any dispute regarding quality of drugs.
  • It prepares and maintains national reference standard. It brings about uniformity in enforcement of Drugs and Cosmetics Act.
  • It trains Drug Analysts deputed by State Drug Control Laboratories and other Institutions.

GS-2 Paper

Topic coveredIssues relating to development and management of Social Sector/Services relating to Health, Education, Human Resources.

Health Index

Context

The second edition of NITI Aayog’s Health Index was recently released in its report titled ‘Healthy States, Progressive India.

About the NITI Aayog’s report

  • The second edition of NITI Aayog’s report focuses on measuring the overall performance and incremental improvement in the states and union territories with 2015-16 as the base year and 2017-18 as the reference year.
  • The health index report has been developed by NITI Aayog, with technical assistance from the World Bank, in consultation with the Ministry of Health and Family Welfare.
  • Health index is based on 23 health indicators with major weightage given to mortality rate, total fertility rate, and sex ratio.
  • The report ranks states and Union territories innovatively on their year-on-year incremental change in health outcomes, as well as, their overall performance with respect to each other.
  • The ranking was done under three categories larger states, smaller states and Union territories (UTs) to ensure comparison among similar entities.
  • It aims to establish an annual systematic tool to measure and understand the heterogeneity and complexity of the nation’s performance in Health.
  • The Health Index does not capture other related dimensions, such as non-communicable diseases, infectious diseases and mental health.

Key findings

  • Kerala is on top the list for the best performing State in the health sector among the 21 large States.
  • Kerala was followed by Andhra Pradesh, Maharashtra, Gujarat and Punjab, Himachal Pradesh, Jammu and Kashmir, Karnataka and Tamil Nadu.
  • In incremental performance, Haryana, Rajasthan, and Jharkhand are at the top.
  • Uttar Pradesh, Bihar, Odisha, Madhya Pradesh, and Uttarakhand have been shown as the worst performers.
  • Overall, only about half the States and UTs showed an improvement in the overall score between 2015-16 (base year) and 2017-18 (reference year).
  • Among the 8 Empowered Action Group States, only 3 States i.e. Rajasthan, Jharkhand and Chhattisgarh showed improvement in the overall performance.
  • Among the smaller states, Mizoram ranked first in overall performance.
  • Tripura and Manipur in smaller state category were the top two states in terms of incremental performance.
  • Overall health index scores have decreased the most for Sikkim and Arunachal Pradesh.

Significance

  • Health Index is a concept to encourage States into action, public health must become part of the mainstream politics.
  • It has been developed as a tool to leverage co-operative and competitive federalism to accelerate the pace of achieving health outcomes.
  • The Centre has paid attention to tertiary care and reduction of out-of-pocket expenses through financial risk protection initiatives such as Ayushman Bharat.
  • It would also serve as an instrument for “nudging” States & Union Territories (UTs) and the Central Ministries to a much greater focus on output and outcome-based measurement of annual performance.

For prelims

The Protection of Human Rights (Amendment) Bill, 2019

Highlights

  • The Protection of Human Rights Act, 1993 was enacted to provide for the constitution of a National Human Rights Commission (NHRC), the State Human Rights Commission (SHRC) and the Human Rights Courts for protection of human rights.
  • The Protection of Human Rights (Amendment) Bill, 2019 provides-
  1. That a person who has been a Judge of the Supreme Court is also made eligible to be appointed as Chairperson of the Commission in addition to the person who has been the Chief Justice of India.
  2. To increase the Members of the Commission from two to three of which, one shall be a woman.
  3. To include Chairperson of the National Commission for Backward Classes, Chairperson of the National Commission for Protection of Child Rights and the Chief Commissioner for Persons with Disabilities as deemed Members of the Commission.
  4. To reduce the term of the Chairperson and Members of the Commission and the State Commissions from five to three years and shall be eligible for re-appointment.
  5. To provide that a person who has been a Judge of a High Court is also made eligible to be appointed as Chairperson of the State Commission in addition to the person who has been the Chief Justice of the High Court.
  6. To confer upon State Commissions, the functions relating to human rights being discharged by the Union territories, other than the Union territory of Delhi, which will be dealt with by the Commission.

 Broadband Readiness Index for 2019-2022

Highlights

  • Broadband Readiness Index is launched by the Department of Telecom (DoT) and the Indian Council for Research on International Economic Relations (ICRIER).
  • The National Digital Communication Policy (NDCP) 2018 acknowledged the need for building a robust digital communications infrastructure.
  • Accordingly, the policy recommended that a Broadband Readiness Index (BRI) for States and UTs be developed to attract investments and address Right of Way challenges across India.
  • This index will appraise the condition of the underlying digital infrastructure and related factors at the State/UT level.
  • In the spirit of competitive federalism, the index will encourage states to cross learn and jointly participate in achieving the overall objective of digital inclusion and development in India.
  • The framework will not only evaluate a state’s relative development but will also allow for better understanding of a state’s strengths and weaknesses that can feed into evidence-based policy making.
  • The index will include indicators such as percentage of households using computers/ laptops with internet connection, percentage of households with fixed broadband connection, internet users as a percentage of the population, smartphones density, percentage of households with at least one digitally literate member, etc.

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