2-May-2018: Cabinet approves accession to the Protocol under WHO Framework Convention on tobacco control to eliminate illicit trade in tobacco products

The Union Cabinet has given approval to accede to the Protocol under World Health Organization (WHO) Framework Convention on tobacco control to eliminate illicit trade in tobacco products. It will be applicable to both smoking and chewing or smokeless tobacco (SLT) forms as  negotiated and adopted under Article 15 of the World Health Organization Framework Convention on Tobacco Control (WHO FCTC).  India is a party to WHO FCTC.

Details: The protocol lays down obligations of the parties. It spells out supply chain control measures that must be adopted by the parties viz. licensing of manufacture of tobacco products and machinery for manufacturing of tobacco products, due diligence to be kept by those engaged in production, tracking and tracing regime, record keeping, security; and measures to be taken by those  engaged in e-commerce, manufacturing in free-trade zones and duty free sales.

The protocol lists out offences, enforcement measures such as seizures and disposal of seized products. It calls for international cooperation in information sharing, maintaining confidentiality, training, technical assistance and cooperation in scientific and technical and technological matters.

Impact: Elimination of illicit trade in tobacco products through strengthened regulation will help in strengthening comprehensive tobacco control, leading to reduction in tobacco use which in turn, will result in reduction in disease burden and mortality associated with tobacco use.

Accession to such treaty will provide actionable alternatives against such prevailing practices that are affecting public health at large. India, being at the forefront of tobacco control, would be able to influence the international organizations including World Custom Organization in controlling such illicit trade.

The protocol to eliminate illicit trade in tobacco products is a path breaking initiative in strengthening global action against tobacco and is also a new legal instrument in public health. It is a comprehensive tool to counter and eventually eliminate illicit trade in tobacco products and to strengthen legal dimensions for international health cooperation.

Background: The WHO Framework Convention on Tobacco Control (WHO FCTC) is the first international public health treaty negotiated under the auspices of the WHO. The objective of FCTC is to provide a framework for supply and demand reduction measures for tobacco control at the national, regional and global levels.

One of the key tobacco supply reduction strategies contained in Article 15 of WHO FCTC envisages elimination of all forms of illicit trade and tobacco products, including smuggling, illicit manufacturing and counterfeiting. Accordingly, the said Protocol was developed and adopted by the Conference of Parties (COP) which is the governing body of FCTC. The protocol is divided into 10 parts and contains 47 Articles.

16-Mar-2017: National Health Policy, 2017 approved by Cabinet

The Union Cabinet has approved the National Health Policy, 2017 (NHP, 2017).  The Policy seeks to reach everyone in a comprehensive integrated way to move towards wellness.  It aims at achieving universal health coverage and delivering quality health care services to all at affordable cost.

This Policy looks at problems and solutions holistically with private sector as strategic partners. It seeks to promote quality of care, focus is on emerging diseases and investment in promotive and preventive healthcare. The policy is patient centric and quality driven. It addresses health security and make in India for drugs and devices.

The main objective of the National Health Policy 2017 is to achieve the highest possible level of good health and well-being, through a preventive and promotive health care orientation in all developmental policies, and to achieve universal access to good quality health care services without anyone having to face financial hardship as a consequence.

In order to provide access and financial protection at secondary and tertiary care levels, the policy proposes free drugs, free diagnostics and free emergency care services in all public hospitals.

The policy envisages strategic purchase of secondary and tertiary care services as a short term measure to supplement and fill critical gaps in the health system.

The Policy recommends prioritizing the role of the Government in shaping health systems in all its dimensions. The roadmap of this new policy is predicated on public spending and provisioning of a public healthcare system that is comprehensive, integrated and accessible to all.

The NHP, 2017 advocates a positive and proactive engagement with the private sector for critical gap filling towards achieving national goals.  It envisages private sector collaboration for strategic purchasing, capacity building, skill development programmes, awareness generation, developing sustainable networks for community to strengthen mental health services, and disaster management. The policy also advocates financial and non-incentives for encouraging the private sector participation.

The policy proposes raising public health expenditure to 2.5% of the GDP in a time bound manner. Policy envisages providing larger package of assured comprehensive primary health care through the Health and Wellness Centers'. This policy denotes important change from very selective to comprehensive primary health care package which includes geriatric health care, palliative care and rehabilitative care services. The policy advocates allocating major proportion (up-to two-thirds or more) of resources to primary care followed by secondary and tertiary care. The policy aspires to provide at the district level most of the secondary care which is currently provided at a medical college hospital.

The policy assigns specific quantitative targets aimed at reduction of disease prevalence/incidence, for health status and programme impact, health system performance and system strengthening. It seeks to strengthen the health, surveillance system and establish registries for diseases of public health importance, by 2020. It also seeks to align other policies for medical devices and equipment with public health goals.

The primary aim of the National Health Policy, 2017, is to inform, clarify, strengthen and prioritize the role of the Government in shaping health systems in all its dimensions- investment in health, organization and financing of healthcare services, prevention of diseases and promotion of good health through cross sectoral action, access to technologies, developing human resources, encouraging medical pluralism, building the knowledge base required for better health, financial protection strategies and regulation and progressive assurance for health. The policy emphasizes reorienting and strengthening the Public Health Institutions across the country, so as to provide universal access to free drugs, diagnostics and other essential healthcare.

The broad principles of the policy is centered on Professionalism, Integrity and Ethics, Equity, Affordability, Universality, Patient Centered & Quality of Care, Accountability and pluralism.

It seeks to ensure improved access and affordability of quality secondary and tertiary care services through a combination of public hospitals and strategic purchasing in healthcare deficit areas from accredited non-­governmental healthcare providers, achieve significant reduction in out of pocket expenditure due to healthcare costs, reinforce trust in public healthcare system and influence operation and growth of private healthcare industry as well as medical technologies in alignment with public health goals.

The policy affirms commitment to pre-emptive care (aimed at pre-empting the occurrence of diseases) to achieve optimum levels of child and adolescent health. The policy envisages school health programmes as a major focus area as also health and hygiene being made a part of the school curriculum.

In order to leverage the pluralistic health care legacy, the policy recommends mainstreaming the different health systems. Towards mainstreaming the potential of AYUSH the policy envisages better access to AYUSH remedies through co-location in public facilities. Yoga would also be introduced much more widely in school and work places as part of promotion of good health.

The policy supports voluntary service in rural and under-served areas on pro-bono basis by recognized healthcare professionals under a 'giving back to society’ initiative.

The policy advocates extensive deployment of digital tools for improving the efficiency and outcome of the healthcare system and proposes establishment of National Digital Health Authority (NDHA) to regulate, develop and deploy digital health across the continuum of care.

The policy advocates a progressively incremental assurance based approach.

The National Health Policy, 2017 adopted an elaborate procedure for its formulation involving stakeholder consultations. Accordingly, the Government of India formulated the Draft National Health Policy and placed it in public domain on 30th December, 2014. Thereafter following detailed consultations with the stakeholders and State Governments, based on the suggestions received, the Draft National Health Policy was further fine-tuned. It received the endorsement of the Central Council for Health & Family Welfare, the apex policy making body, in its Twelfth Conference held on 27th February, 2016.

The last health policy was formulated in 2002. The socio economic and epidemiological changes since then necessitated the formulation of a New National Health Policy to address the current and emerging challenges.

2-Feb-2017: Health Ministry Notifies Medical Devices Rules, 2017

The Ministry of Health and Family Welfare has notified Medical Devices Rules, 2017 on 31.01.2017. The new Rules have been framed in conformity with Global Harmonisation Task Force (GHTF) framework and conform to best international practices.  Only 15 categories of medical devices are, at present, regulated as drugs and to that extent, the current regulatory practices in India were not fully geared to meet the requirements of medical devices sector in the country.  The new Rules seek to remove regulatory bottlenecks to make in India, facilitate ease of doing business while ensuring availability of better medical devices for patient care and safety.

Medical devices will, under the new Rules, be classified as per GHTF practice, based on associated risks, into Class A (low risk), Class B (low moderate risk), Class C (moderate high risk) and Class D (high risk). The manufacturers of medical devices will be required to meet risk proportionate regulatory requirements that have been specified in the Rules and are based on best international practices.