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Monday, November 26, 2012

Draft NATIONAL PHARMACEUTICALS PRICING POLICY, 2011 approved by Union Cabinet : All stakeholders unhappy ---Debates galore !!!


Draft NATIONAL PHARMACEUTICALS PRICING POLICY, 2011 aimed at ensuring access of essential medicines was approved recently by Union Cabinet . It remains to be seen, whether this policy initiative which was received by both industry and civil society with much caution and skepticism, actually translates in benefits to patients, consumers vis-a-vis interests of manufacturers.

This comes in the backdrop of Report of the Task Force to Explore Options Other than Price Control for achieving the objective making available life-saving drugs at reasonable prices . This Task Force recommended that price regulation should be on the basis of ‘Essentiality’ of the drug and it should be applied only to formulations and not to upstream products, such as bulk drugs. Essential medicines are those that satisfy the priority health care needs of the population and are selected with due regard to disease prevalence, evidence on efficacy and safety, and comparative cost-effectiveness. An essential medicines list is a list of minimum medicines that a country should have, so as to be able to take care of the health needs of a majority of its population. If you were short of resources, you could at least stock these in sufficient quantities and at affordable rates. 

Source: http://apps.who.int/medicinedocs/es/d/Js2296e/2.html

Report of this Task Force also maintained that, "No effort should be made to impose a uniform price, and only a ceiling price should be indicated. The ceiling price of essential drugs should normally not be based on cost of production but on readily monitorable market based benchmarks. Other drugs falling into selected therapeutic categories should be brought under a comprehensive price monitoring system with mandatory price negotiations system, if necessary.A process of active promotion of generic drugs should be put in place including mandatory debranding for selected drugs. Public Sector Enterprises (PSEs) involved in the manufacture of drugs should be revived where possible and used as key strategic interventions for addressing both price and availability issues. The drug regulator must maintain a data base of brands and their compositions and no change should be permitted in the composition of a given brand."

WHO Framework for Medicine Pricing and Financing


Under the proposed policy, the ministry has moved away from the existing economic/market share principle-based criteria of price fixation to “essentiality” based price control. This change of criteria was warranted by an eight-year directive from the Supreme Court, which had asked the central government to formulate a medicine price control mechanism to cover all essential drugs. (Read here)

The proposal of NPPP 2011 to regulate prices of all the 348 drugs in the NLEM 2011, though paved with good intentions, has inbuilt ways to escape from price regulation. A list that is the basis for price regulation needs to cover all these 800-1,000 molecules. Therefore the NLEM 2011 with 348 molecules will defeat the purpose of price regulation. 

Background of New Policy:
The control over prices was on the basis of the cost of production with allowance being given to post-production expenses. Later around Yr 2000 when FDI norms in pharma sector were brought at the level of automatic route raising the limit to 100%. All drugs where unit price is Rs. 2 were excluded from the ambit of price control. There were also exemptions to the drugs developed through indigenous R&D. , new delivery systems etc. Twin challenge of ensuring industrial growth and ensuring public health is at loggerheads with shifting and interchanging priorities in the whirlwind of debate over new pricing policy in the context of details mentioned above.

Towards Practical applications of the essential medicines concept: How ? 
• Basic and in-service training of health care providers
• Public-sector procurement and distribution
• Medicine benefits as part of health insurance
• Drug donations and international aid
• Monitoring systems on availability and pricing
• Public education.



Facts
a) Directory of Pharmaceutical Units in India- http://nppaindia.nic.in/directory-nppa.pdf

b) List of Essential Medicine: http://pharmaceuticals.gov.in/NLEM.pdf

c) Medicine price information methodology by WHO: http://www.who.int/medicines/areas/access/ecofin/en/index.html

d) Mandate of Dept. of Pharmaceuticals: 
---> Promotion and co-ordination of basic, applied and other research in areas related to the
Pharmaceuticals sector.
---> Development of infrastructure, manpower and skills for the Pharmaceuticals sector and
management of related information.
---> Education and training including high end research and grant of fellowships in India and
abroad, exchange of information and technical guidance on all matters relating to pharmaceutical sector.
---> Promotion of public – private – partnership in pharmaceutical related areas.
---> International cooperation in pharmaceutical research, including work related to international conferences in related areas in India and abroad.
---> Inter-sectoral coordination including coordination between organizations and institutes under the Central and State Governments in areas related to the subjects entrusted to the Department.
---> Technical support for dealing with national hazards in pharmaceutical sector.
---> All matters relating to National Pharmaceuticals Pricing Authority including related functions of price control/monitoring.
---> All matters relating to National Institutes for Pharmaceuticals Education and Research
(NIPERs).
---> Planning, development and control of; and assistance to, all industries dealt with by the
Department.

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Monday, November 19, 2012

Draft of The Science, Technology and Innovation Policy Government of India New Delhi January, 2013 released...


 
Science in Shaping the Future of an Aspiring India
Science, Technology and Innovation (STI) have emerged as the major drivers of
socio- economic development globally. India of the 21st century is an aspiring
country. Faster, sustainable and inclusive growth is her aspiration. Science,
Technology and Innovation leading to applications of products of Research and
Development will need to play defining roles. The large demographic dividend
and talent pool of the country offer unique opportunities the National STI
enterprise for earning for itself a central position in national development though
its excellence, relevance and performance.

What is innovation?
Scientific research converts money into knowledge and innovation converts
knowledge into wealth. Innovation is more than mere conversion of knowledge
into a workable technology. It implies an S&T-led solution that is successfully
deployed in the economy or society. India has, hitherto accorded little
importance to this aspect. There is now an urgent need to invigorate this aspect
of the national STI enterprise.

Changing Phases of National Policies in S&T
India’s Scientific Policy Resolution (SPR) of 1958, a pace setter in the world,
remains valid even today. The SPR resolved to “foster, promote and sustain” the
“cultivation of science and scientific research in all its aspects”. Technology was
then assumed to flow from the country’s established science infrastructure. The
SPR also emphasized the use of the scientific approach in all activities of the
nation. The Technology Policy Statement (TPS) of 1983, enunciated at a time of
constraints on import of technology, emphasized the need to attain technological
competence and self-reliance. Several of its statements were converted into
action. The Science and Technology Policy (STP) of 2003 brought science and
technology (S&T) together. It emphasized the need for investment into R&D to
address national problems. It called for integrating programmes of socioeconomic
sectors with the national R&D system. It also articulated the need for
technological innovation and creation of a national innovation system. The world
has changed vastly since then in all spheres of human activity

Why another policy?
Today innovation is no longer a mere appendage to science and technology but
has assumed centre stage in the developmental goals of countries around the
world. Vertical integration of all dimensions of STI into the socio-economic
processes seems the way forward in the modern world. New paradigms of
innovation have emerged and systems that foster innovation are not universal.
They have become country and context specific. The Prime Minister of India, at
the Indian Science Congress-2010 declared 2010-20 as the “Decade of
Innovations” and formed the National Innovation Council. The Prime Minister
and Minister of Science & Technology declared at the 99th Science Congress the
bringing forth of a policy that develops the synergy between science, technology
and innovation. The STI Policy 2013 is in furtherance of the declaration and aims
to bring fresh perspectives to bear on innovation in the changing context. The
policy thus seeks to focus on both people for science and science for people and
combine the benefits of excellence and relevance.

Policy for Science and Science Policy for Development: A New Paradigm
Science, research and innovation can exist separately on their own in
disconnected spaces. But there are synergistic linkages. India’s global
competitiveness will be determined by the extent to which the STI enterprise
integrates vertically and is able to create social good and economic good through
innovation. Innovative structural mechanisms and models will thus need to be
evolved to balance the priorities and develop interconnections of the three
sectors.

India’s STI system needs to deliver solutions to address the pressing national
challenges of energy and food security, nutrition, affordable health care,
environment, water and sanitation and above all employment .Thus discovery
and solution dimensions of science and technology need to play major roles in
shaping the future of the country. “Science and technology for the people” will be
the new paradigm of the Indian STI enterprise. Indian society must emerge as
the major stake holder for the national STI system.

India’s STI-led developmental efforts should thus aim at faster, inclusive and
sustainable growth. While global competitiveness in trade would call for high technology
inputs, inclusive growth would need to ensure access, availability
and affordability of solutions to as large a population as possible. India needs
‘inclusive innovation’. The policy will thus drive both investment in science and

investment of science-led technology and innovation in agriculture,
manufacturing and services that lead to socio-economic benefits to a wide cross
section of society. Emphasis will be laid on bridging the gaps between
knowledge and the economic sectors. The STI policy would develop symbiotic
relationship with economic and other policies.

Capturing aspirations
The key elements of the STI policy will be:
_ Promoting proliferation of scientific temper amongst all sections of society.
_ Enhancing skill for applications of science among the young from all social
strata
_ Making careers in science, research and innovation attractive to the brightest.
_ Establishing world class R&D infrastructure for gaining global leadership in
some select frontier areas of science.
_ Positioning India among the top five global scientific powers by 2020.
_ Linking contributions of science, research and innovation system with
inclusive economic growth agenda and combine priorities of excellence with
relevance
_ Migrating R&D outputs into commercial applications by replicating hitherto
successful models as well as establishment of new structures.
_ Facilitating S&T-based high-risk innovations. through new mechanisms
_ Triggering changes in the mindset and value systems to recognize, respect
and reward performances which create wealth from S&T derived knowledge.

Investment in Research and Development
Global investments in science, technology and innovation are estimated at $1.2
trillion as of 2009. India’s R&D investment is less than 2.5% of the global
investments. India’s R&D investment has been under 1% of the GDP. Increasing
Gross Expenditure in Research and Development (GERD) to 2% of the GDP has
been a national goal for some time. Achieving this in the next five years is
realizable provided the private sector matches India’s public investment and the
ratio of public to private sector investments in R&D changes from the current 3:1
to 1:1 within the next five years. This seems attainable as the industrial R&D
investment grew by 250% while the sales growth was at 200% between 2005 and
2010. An environment conducive for enhancing private sector investment in
R&D will be created.

Gross budgetary support for the science and technology sector has significantly
increased during the last decade. Accrual of benefits of such increase in the
GERD is becoming evident. India’s global share of scientific publications has, for
example, increased from 1.8% in 2001 to 3.5% in 2011. The Composite Annual
Growth Rate (CAGR) of Indian publications during the last three years is around
12±1%. But the percentage of Indian publications in the top 1% impact making
journals is only 2.5%. India should aim to increase its share of scientific
publications from the current 3.5% to over 7% and quadruple the number of
papers in top 1% journals from the current levels by 2020. Citation impact of
Indian publications must improve and match at least the global averages.
Initiatives under the new policy should enable this to exceed the global average
by 2020.

India ranks ninth globally in the number of scientific publications and 12th in the
number of patents filed. According to the Global Science Report of the UNESCO,
India’s current global ranking matches with its ranking with respect to the
number of Full-Time Equivalent (FTE) of R&D personnel. In order to match the
enhanced level of private sector investments in R&D and to maintain the tempo
of public sector investments, it is imperative that within the next five years the
total number of FTE of R&D personnel must increase by at least 66% of the
present strength.

Nourishing the root of Science for promoting Excellence in Research
Ensuring sustainable pipeline of talented youth for science is a challenge. India
has mounted some significant initiatives for attracting talent to science and
careers with research. Empowering stakeholders for local actions is a key
element of these initiatives. The policy framework will further enable school
science education through improvement of teaching methods and science
curricula, motivating science teachers and schemes for early attraction of talent to
science.

Combining Excellence and Relevance: Way Forward for Indian
Science
Basic research-led discoveries stimulate innovation in the long term. While
Indian investment in basic research will be further enhanced by fostering
excellence through global benchmarks and focusing on relevance for addressing
national challenges.

The few inter-university centres set up earlier have proved the concept to be a
successful and viable one. Such inter-university centres would be multiplied in
different fields to enable a wide cross section of university researchers to access
advanced research facilities and equipment which are otherwise not available in
university environments. Grand challenge programmes, where resource
deployment could bring tangible and intangible returns in the global setting, will
be launched.

Participation in Creation of Large Global R&D Infrastructures and Big
Science
Modern science is increasingly becoming resource intensive. There is a current
trend to create high-cost global infrastructures through international consortia
models. Given India’s global standing in science, invitation to participate in such
projects is expected to increase. Indian participation in such consortia-led
international projects will be encouraged and facilitated for improving access to
facilities for advanced research in cutting edge areas of science.

Attracting Private Sector Investments in R&D
Supply side interventions have hitherto been the main strategy for public
investment in R&D. The situation requires changing; equal emphasis on both
supply side interventions and demand based investments is needed. While
public investments in R&D should maintain the current rates of growth, private
investment has to increase significantly for translating R&D outputs into
commercial outcomes.

Public funds for partnerships with the private sector for social and public good
objectives will be earmarked as a new policy initiative. A National Science,
Technology and Innovation Foundation will be established as a Public Private
Partnership (PPP) initiative for investing critical levels of resources for
innovative and ambitious projects.
The focus of the policy environment will be:
_ Facilitating private sector investment in R&D centres in India and overseas.
_ Permitting multi stakeholders participation in the Indian R&D system.
_ Treating R&D in the private sector at par with public institutions for availing
public funds.
_ Bench marking of R&D funding mechanisms and patterns globally.
_ Aligning Venture Capital and Inclusion Innovation Fund systems.
_ Modifying IPR policy to provide for marching rights for social good when
supported by public funds and for co-sharing IPRs generated under PPP.
Science, Technology, Innovation Policy 2013 Page 6
_ Exploring newer mechanisms for fostering Technology Business Incubators
(TBIs) and science-led entrepreneurship.
_ Providing incentives for commercialization of innovations with focus on
green manufacturing.

Partnerships among Stake holders for Scaling Successes of R&D
Special and innovative mechanisms for leveraging academia-research-industry
partnerships will be devised. Success stories in S&T-based innovations from
Indian experience would be replicated and scaled up. Regulatory and legal
framework for sharing of IPRs between inventors and investors, and for closing
gaps in the translation of new findings into the commercial space, would be put
in place. Specifically the policy will focus on:
_ Prioritizing critical R&D areas like agriculture, telecommunications, energy,
water management, drug discovery, material science including nano
technology, climate change and space technology and promoting interdisciplinary
research,
_ Promoting innovations through mechanisms including “Small Idea-Small
Money” and “Risky Idea Fund” to support innovation incubators
_ Supporting STI driven entrepreneurship with high scaling coefficients and
viable business models,
_ Investing in young innovators and entrepreneurs through education and
training.

Gaining Global Competitiveness through Collaboration
Open source discoveries for public and social good form interesting innovation
systems. Knowledge commons is an emerging theme for managing IPRs created
through multi-stake holder participation. The STI Policy will foster data sharing
and access. Tapping global resources and especially Indian diaspora for
accelerating the pace of technology-led development would be pursued. Multisectoral
partnerships and alliances will be leveraged for upscaling national
competitiveness in research and manufacturing. The new policy framework will
enable strategic partnerships and alliances with other nations through both
bilateral and multilateral cooperation in science, technology and innovation.
Cooperation in areas like climate change and mitigating natural disasters are
important and beneficial. Science diplomacy, technology synergy and technology
acquisition models should be judiciously deployed based on strategic
relationships.

Performance-Reward Relationships
Transparent systems for tracking individual research performers based on past
and proven track record would be developed to enable grant based investments
in such performers. A well-designed centrally implementable Performance
Related Incentive Scheme (PRIS) for basic research leading to scientific
publications would be put in place.
For R&D leading to technology development and knowledge services, the
criteria would, however, be specific to the institution, the local conditions and
the context. Incentives to public-funded R&D centres for outcomes leading to
public and strategic goods could be introduced. Transparent performance reward
relationships and accountability for investments would form central
theme of the policy.

Leveraging Innovation potentials for Social Inclusion
Global innovations systems tend to bypass large sections of the community. The
instruments of the STI policy will aim at increasing accessibility, availability and
affordability of innovations. Establishment of a Fund for Innovations for Social
Inclusion will be a step in this direction.

Delivery systems for STI outputs to stake holders and Society
Migration of scientific outputs and technology interventions into the social
systems is a multi-layered process. Direct delivery of scientific outputs through
dissemination and public outreach by the scientific agencies and bodies is
possible only in relatively smaller number of sectors. The entire delivery
mechanism involves a large number of intermediaries from the public, nongovernmental
and private sectors. This requires strengthening of linkages
between the scientific and socio-economic sectors. The STI policy will leverage
the R&D allocations of socio-economic ministries through a shared vision on
addressing developmental challenges, co-generation of values through
partnerships, and co-investments, adoption of new delivery models and
maximization of stakeholder value perceptions.

The state governments constitute important stake holders and measures will be
taken to ensure that state-specific S&T vision and plans are informed by the new
STI Policy.

Transition from perception to evidence-based approaches for investment
decisions
Sound measurement principles for STI indicators are necessary for evidence
based policy actions. New and globally relevant indicators, which integrate
measures of excellence with relevance as well as inventiveness with affordability,
will be developed. Around 10 sectors of high impact potential, with commitment
to deploy commensurate resources, will be identified for directed STI
intervention. Enabling policy instruments that facilitate both research and
enterprise to focus their efforts in these will be put in place.
Global competitiveness of manufacturing sector is closely related to the
technology intensity of the sector, which in turn is a direct corollary of the
vitality of the R&D system in providing technology inputs. India’s share of
global trade in high technology products is presently only around 8%. The aim is
to double this share through innovations in high-technology products.
Appropriate supporting instruments will be put in place to stimulate the
development and deployment of high technology by industry.

Triggering Ecosystem changes for Science, Technology and
Innovation
A flexible approach that allows for fine tuning the Five Year Plan investments in
R&D, technology and innovation in response to rapid changes in STI ecosystem
would be put in place. Speed, scale and sustainability would be key governance
parameters for the new approach. Internal processes of institutions need to
build-in Trust as an integral principle in decision making. “Risks” are integral
parts of a vibrant national innovation system and policies must provide for risk
management strategies. Education is currently focused on understanding; it
should now embrace emphasis on Applications as well. Venture capital systems
need to adventure in risky innovations rather than to rely on incremental
innovations, new financing mechanisms for investing in enterprises without fear
of failure and options for foreclosing unsuccessful ventures are essential part of
such an enabling innovation ecosystem. India’s innovation machinery should
aim to lead rather than to follow safe paths of discovery. Hence Trust, Risk,
Application, Venture. Enterprise and Leadership should form new mantras of
the new STI ecosystem.

Gender Parity in STI Sector
Participation of women in STI activities is important. New and flexible schemes
would be put in place to address the mobility challenges of employed women
scientists and technologists. A broad scope for re-entry of women into R&D and
new facilitation mechanisms with special career path in diverse areas will also be
made feasible.

Public Awareness and Public Accountability of Indian STI sector
Public understanding of science is an important dimension for introducing and
reaching the benefits of modern science and technology to the people. Public and
political understanding of science should be based on evidence and debates with
open mind. The civilizational aspect of science or scientific temper needs to be
promoted across all sections of the society systematically. People and decision
makers must be made aware of the implications of emerging technologies,
including their ethical, social and economic dimensions. Effective science
communication methods, by using tools such as the National Knowledge
Network, will be initiated. These will enable all the stakeholders of the civil
society to discuss and present a collective perspective on such developments.
Mechanisms for assessing the performance of the national STI system by all the
stakeholders and reporting to the nation on a periodic basis will be established.
The national science academies will be accorded a major role in this endeavour of
public accountability.

Science, Technology and Innovation to serve National Agenda
Agriculture: R&D policy for agriculture is articulated by the Indian Council of
Agriculture Research (ICAR). Integration of the agriculture R&D policy with the
national R&D system and STI policy will be brought about.

Manufacturing: STI inputs to manufacturing sector offer opportunities for
enhanced employment generation. A strategic selection of sectors, where India
can aspire for leadership, would be made for focused STI inputs. A special drive
for stepping up R&D intensity in key manufacturing sectors with competitive
advantage will be mounted. Small and Medium Enterprises (SME) generally
have low R&D intensity. Special schemes to support R&D at the firm or
collective level, will be devised and put in place.

Services: The R&D intensity of the service sector needs to be enhanced
considerably and skill base also expanded significantly. Linkages between the
services with educational sectors for establishing human capacities will be
fostered through incentive mechanisms. For rapidly accomplishing the tasks of
modernization of technology-led services, technology missions, aimed at
achieving global leadership in some select areas in the services sector, will be
identified. Deployment of technology-led services for increasing transparency in
the Government machinery will also be supported.

Climate Change: Climate change is of global concern and India has articulated a
National Action Plan for Climate Change (NAPCC). The S &T system will have
to play an active role as a source of strategic knowledge for coping with the
challenges of climate change as well as in meeting equity-based differentiated
and shared responsibilities of India.

Policy Goal
STI policy 2013 is focused on serving India by connecting performance with
excellence and relevance. The policy goal of the Indian STI sector is to accelerate
the pace of discovery and delivery of science-led solutions for serving the
aspirational goals of India for faster, sustainable and inclusive growth. A strong
and viable Science, Research and Innovation System for High Technology-led
path for India (SRISHTI) is the goal of the new STI policy. Aspirations of India
would be serviced by an equally aspiring Indian STI system.

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