In the 5th century, the first codes of medical ethics were framed based on the Hippocratic’s oath, who is considered as “Father of western medicine”.

The Hippocratic’s oath has been regulating the ethical behavior of doctors for centuries. WHO revised the Hippocratic’s oath after Second World War and this revised version has been accepted as the international code of medical ethics world over.

Now, the Ministry of Health and Family Welfare controls all the health policies in India. Central Drugs Standard Control Organization is a regulatory body for pharmaceutical and medical devices in India. The Medical Council of India sets standards of medical education, recognizes medical qualifications, gives accreditation to medical schools, grants registration to medical practitioners and monitors medical practices in India. Both these organizations are affiliated with Ministry of Health and Family Welfare. This article briefs about the laws that changed or subjected to change in the year 2017.

Various policies, bills and laws relating to medicine and/or clinical practice were either submitted for approval or approved in 2017. 

A) Medical Device Rules, 2017

Regulating the manufacturing of medical devices and in-vitro diagnostic devices (IVD) is important as their quality will affect patient’s safety. Medical Device Rules were published on 31-Jan-2017 and will come into effect from 01-Jan-2018. The highlights of Medical Device Rules 2017 are as follows:

• Medical devices and IVD are classified based on the risk
• The licence fees to be revised based on the classification of devices
• From 01-Jan-2022 onwards, all the medical devices and IVDs should have their unique identification codes
• Manufacturing licence will be issued only after the audit of the manufacturing site which is done by notified bodies
• Test licence will be valid for 3 years; currently, it is valid only for 1 year
• The licences issued will be valid indefinitely, provided the retention fee is paid unless cancelled or surrendered
• Licences and registration certificates issued prior to implementation of Medical Device Rules will remain valid either until expiry or until an 18-month period following the implementation, whichever is later
  
  Read more about the Medical Devices Rules,2017 here.

B) National Health Policy, 2017

National Health Policy (2017) was approved for the first time in the past 15 years; the earlier policy was framed in 2002. The objective of National Health Policy, 2017 is to deliver quality healthcare to underserved and under privileged people of India at an affordable cost. It promotes the use of drugs and devices manufactured in India in accordance with ‘Make in India’ initiative. The significant points of National Health Policy, 2017 include:

• Supporting pre-screening to reduce morbidity and mortality caused by non-communicable diseases
•  Revised articulation of “health and wellness centers” – a term used to denote transforming the current sub-centre and PHC from its current and very limited package of services to a much larger coverage of non-communicable diseases 
• Focusing on primary health care by ensuring availability of 2 beds per 1000 people
• Adopting Ayurveda, Yoga & Naturopathy, Unani, Siddha and Homeopathy (AYUSH) for prevention of a disease as they are cost-effective
• Promotion of teleconsultation between specialist consultants and tertiary care centers
• Grading of establishments and active promotion of standard treatment guidelines

C) Public Health bill, 2017

Public Health bill (2017) is prepared jointly by National Centre for Disease Control (NCDC) and Directorate General of Health Services (DGHS). The bill has been submitted to the law ministry for approval. It aims to prevent, control and manage epidemics, bio-terrorism and disasters. As per the bill, central, state or local authorities can inspect any premises, isolate people, perform a laboratory test and give the required treatment and vaccination without the patient’s consent.

Public Health Bill does not give a patient “right to consent”. It is unethical but if the bill is passed, it becomes lawful and can be practiced.

D) Prevention of Cut Practices in Healthcare Services Act, 2017

Medical services are commercialized in India; cash or gifts are being given as a commission to the referring doctor upon patient referral. This practice is referred to as cut-practice in the medical profession. Maharashtra government wants to curb this practice, so “Prevention of Cut Practices in Healthcare Services Act (2017)” has been drafted and submitted to law and judiciary department for its approval. As per the draft copy of the act, any person or institution if found guilty of cut practice have to be imprisoned for 1 year or should pay a fine of Rs 50,000. Approval of this act might reduce the commercialisation in the medical profession.

E) A step to change India’s code of medical ethics

In October 2017, World Medical Association updated a statement that “it is unethical for doctors to be a part of capital punishment”. Later, Indian Medical Association had asked Medical Council of India to add a statement in this aspect in India’s code of medical ethics. A lot of discussion is being done on this topic and its approval is awaited.

Many doctors feel that medical profession is dedicated to saving lives, and medical professionals should not be a part of planning, instructing and training people for the execution of convicts.

The Indian government has rules and policies for all the aspects of healthcare. Effective implementation of these laws will increase the standard of healthcare in India by increasing the productivity, affordability, quality and effectiveness of services provided.