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India PharmaSummit 2014-15
India PharmaSummit 2014-15
“Focus on Critical Verticals to Foster Access to Pharmaceuticals, Enhancing Production and Technology Adoption in
Pharmaceutical Enterprises & Medical Devices and Diagnostics”
Policy Landscape Reforms for Strengthening Indian Pharmaceutical Industry
rd23 March 2015, Ramada Plaza Palm Grove, Mumbai
Position Paper
India PharmaSummit 2014-15
“Focus on Critical Verticals to Foster Access to Pharmaceuticals, Enhancing Production and Technology Adoption in
Pharmaceutical Enterprises & Medical Devices and Diagnostics”
rd23 March 2015, Ramada Plaza Palm Grove, Mumbai
Position Paper
Policy Landscape Reforms for Strengthening Indian Pharmaceutical Industry
1. Overview of the Indian Pharmaceutical Sector. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
2. Critical Verticals to Foster Access to Pharmaceuticals at . . . . . . . . . . . . . . . . . . . . . . . . . 5
National and International level
3. Promoting Production and Technology adoption in Pharmaceutical Enterprises. . . . . 11
for meeting National and Global Public Health needs
4. Regulatory Issues and Challenges for Medical Devices and Diagnostics . . . . . . . . . . . 17
Table of Contents
The Indian Pharmaceutical industry has achieved an eminent global position in pharma sector and has
been witnessing phenomenal growth in recent years. It is well known that India is emerging as a
world leader in generic pharmaceuticals production, supplying 20% of the global market for generic
medicines. The industry accounts for 8% of global production, and is exporting to over 200 countries
(1). India is a major vaccine producer and has 18 major vaccine manufacturing facilities. These vaccines
are used for the national and international market (150 countries)which makes India a major vaccine
supplier across the globe.
Indian pharmaceutical industry has been playing a pivotal role in supply of affordable and quality
pharmaceuticals to the developed and developing countries.It is third largest in terms of volume and
thirteen largest in terms of value. The industry is estimated to grow at 20% compound annual growth
rate (CAGR) over the next five years. India is among the top 20 pharmaceutical exporting countries and
the exports havegrown very significantly at a CAGR of around 19% in the 11th plan period. The
industry has seen tremendous progress in terms of infrastructure development, technology base and
the wide range of products manufactured (1).
The Government of India aims at making India a global leader in end-to-end drug manufacture. It has
reduced approval time for new facilities to boost investments. The Department of Pharmaceuticals has
declared the year of 2015 as the Year of Active Pharmaceutical Ingredients and was also recently
launched by the Union Minister of Chemicals & Fertilizers, Mr Ananth Kumar. Speaking at the launch
ceremony, he said that “the Bulk Drugs constitute the backbone of the Pharmaceutical Industry and
the sector needs to be incentivized so as to take on the challenge from cheap imports. There can be
no compromise with the quality, environmental requirements or regulatory necessities but the issues
hampering the growth of the industry have to be addressed. Over-dependence on imports from one
country for bulk drugs is detrimental to the country's interest and hence, paradigm shift is necessary”
The theme for this year's India Pharma Summit is 'Policy Landscape Reforms for Strengthening Indian
Pharmaceutical Industry'. The theme has been chosen to ensure that the factors which have maximum
impact on the current progress of the Indian Pharmaceutical sector are discussed in detail. Three
themes under which specific deliberations would be conducted are the Critical Verticals to Foster
Access to Pharmaceuticals at National and International level, Promoting Production and Technology
adoption in Pharmaceutical Enterprises for Meeting National and Global Public Health Needs and
Regulatory issues and challenges for Medical Devices and Diagnostics.
2 | India Pharma Summit 2014-15: Policy Landscape Reforms for Strengthening Indian Pharmaceutical Industry
Overview of the Indian Pharmaceutical Sector Introduction
The amendments of the existing Foreign Direct Investment (FDI) policy in the pharmaceutical sector in
order to cover medical devices have been recently approved. The Cabinet has allowed FDI up to 100
per cent under the automatic route for manufacturing of medical devices subject to specified
conditions. This would facilitate preparedness of the domestic industry for local innovation and
manufacturing and thereby ensuring the 'Make in India' policy a reality for the progress of health care
sector and benefit of patients. The Department of Industrial Policy and Promotion (DIPP) has released
a report quoting that the drugs and pharmaceuticals sector attracted cumulative foreign direct
investment (FDI) inflows worth US$ 12,813.02 million between April 2000 and December 2014.
Although India has been the global supplier of high quality medicines, maintaining continuous access
to essential medicines remains a challenge to the health system. To maintain continual access to
affordable medicines and health products, it is necessary to augment the capacity of the generic
Indian pharmaceutical enterprises to meet the quality, safety and efficacy standards at National and
Global level. This would further require efficient production and technology adoption measures to
ensure smooth access to the essential and good quality medicines.
The Department of Pharmaceuticals has been continually enabling the Indian pharmaceuticals industry
to play a leading role in the global market and to ensure abundant availability of good quality medicines
at reasonable prices within the country for mass consumption.
Under “Make in India” initiative for creating an enabling framework for stimulating
investments in Pharma manufacturing, Department of Pharmaceuticals has formed Task
Forces on
TF 1- Enabling the Private Sector to lead the growth of Pharmaceutical sector
TF 2- Medical Devices and Pharmaceutical Manufacturing Equipments
TF 3- Development of capabilities for each critical vertical
Health systems need to promote access to essential medical products, rational use of medicines and
the sustainability of health systems. Coordinated action is needed by policy makers, relevant actors in
health systems including WHO which supports countries in strengthening their regulatory systems of
medical products for human use and international communityin promoting equitable access to quality,
safe, efficacious, and affordable medical products. Effective regulatoryand implementation
mechanismsare importanttorespond to the dual burden of infectious and noncommunicable diseasesin
India and in achieving Millennium Development Goals.
3 | India Pharma Summit 2014-15: Policy Landscape Reforms for Strengthening Indian Pharmaceutical Industry
Background
The Millennium Development Goals (MDGs) clearly acknowledge the need to improve access for the
poor to essential drugs on a sustainable basis. Essential pharmaceuticals in Universal Health Coverage
have to be seen in the context of proper quality, availability, prices and procurement systems, reliable
supply of pharmaceuticals, consumables, diagnostics, Information and communications technology
and other technologies as well as health facilities (Primary Health Centres, clinics, hospitals, etc.) is
also crucial.
Assured access to essential medicines would be facilitated through government commitment, access
to public sector financing, careful selection, efficient procurement and distribution systems and up-to-
date information about the availability and affordability of medicines at the point of care. This complex
web of activities requires cooperation between the public and private sectors, prescribers and
dispensers, and between different government institutions.
When medicines are not available in the public sector, patients are purchasing medicines out-of-pocket
from the higher priced private sector, or foregoing treatment altogether. Such expenditure is the main
reason for the impoverishing health costs in India. Therefore, essential medicines which satisfy the
priority health care needs of the population should be made available within the context of the health
system at all times in adequate amounts, in appropriate dosage forms, with assured quality and at a
price the individual and the community can afford.
The Indian pharmaceutical industry has grown rapidly in terms of infrastructure, technology base and
range of products. However, in light of the changing epidemiological reality of India, with a dual burden
of communicable and non-communicable diseases, weak health systems, and a relatively lower public
funding for health, access to medicines has become pivotal. Fostering access to good quality
pharmaceuticals is critical to attain India's goal of Universal Health Coverage (UHC)(2).
India accounts for 8% of global pharmaceutical production of drugs and medical equipments. India is
the most important supplier of generic medicines (20% by value of the global market). Indian
manufacturers are the most important suppliers of generic medicines to many countries and key
contributors to the WHO Prequalification Programme (PQP), which ensures the safety and efficacy of
medicines by setting standards for generic medicines.More than 65-70% of medicines in the WHO
Prequalified List of Medicinal Products belong to Indian manufacturers in the segments of HIV-
AIDS, Tuberculosis, Malaria, Reproductive Health, and other categories (3).
6 | India Pharma Summit 2014-15: Policy Landscape Reforms for Strengthening Indian Pharmaceutical Industry
Critical Verticals to Foster Access to Pharmaceuticals at National andInternational level
India has shown a commitment and a strong political will to strengthen and build capacity of the
National Regulatory Authorities (NRA). There is provision of large funds for strengthening drug
regulatory authority and drug testing laboratories in the 12th Five Year Plan of the GOI and funds have
been allocated appropriately. In the recent WHO NRA Assessment of the National Regulatory
Authority, conducted in December 2012, India has been declared as 'functional' against the
indicators. The effective regulatory oversight of vaccines is especially crucial for India, which is a major
vaccine producer and also supplier across
the globe. WHO had scaled up its
technical support to the Indian NRA over
the past several months in the context of
this assessment. The recent success is a
culmination of intensive effort by
CDSCO, in collaboration with WHO, to
implement the roadmap to strengthen
capacity for regulation of vaccines. With a
regulatory system for vaccines assessed
as funct iona l by WHO, vacc ine
manufacturers in India continue to
r e m a i n e l i g i b l e t o a p p l y f o r
prequalification of specific products (4).
7 | India Pharma Summit 2014-15: Policy Landscape Reforms for Strengthening Indian Pharmaceutical Industry
Figure 1: Manufacturers of WHO List of prequalified
APIs, As on February 2015
Figure 2 Growing share of medicines produced in India on WHO List of prequalified Medicinal Products,
As on February 2015
:
India China Others
0
5
10
15
20
25
30
35
40
45
50
RH
Malaria
TB
HIV
0
0100
200
300
400
500
600
Rest
India
2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014
Policy alternatives
The challenge for policymakers is
how to cap i t a l i ze on the
achievements of the Indian
pharmaceutical sector to improve
access to medicines and make
health systems responsive to the
health needs of the population.
E v i d e n c e s h o w s t h a t
infrastructure development,
capacity building of human
r e s o u r c e s , p r o c u r e m e n t
strategies, policies on generic
medic ines, new regulator y
frameworks, and government
coordination for approvals are
crucial to foster access.
There is a need for investments in infrastructure (e.g. for safety and testing or R&D) and human
resources (e.g. trained personnel with sufficient technical and pharmacy based knowledge). Human
resource development efforts and infrastructure creation is also required at state level so as to to
improve the number and competencies of human resources, promote the domestic production of
drugs, medical devices, and equipment for drug manufacturing. States could also explore technology
transfer mechanisms as well as knowledge sharing regimes to promote the establishment of local
pharmaceutical industries.
Investments in Information Technology systems to improve procurement, distribution, warehousing
and dispensing of medicines is also a critical for the states as health is a state responsibility. WHO
India has provided policy level and technical support to the new procurement agency of Government
of India, the Central Medical Services Society (CMSS) and undertook the ‘Mapping of IT software used
for Procurement of Pharmaceuticals in States in India’. The summary outcomes and the
recommendations were presented to the Technical Expert Committee for identifying IT agency for
Drug Distribution and Management System for central procurement of pharmaceuticals in Ministry of
Health and its linkage with all the States in India.
Quality in medicines is one of the cornerstones of health care and has a major impact on access and
costs. Medicines of good quality improve the chances of successful treatment for individual patients
and promote better outcomes for public health in general.It is important for drug regulatory authorities
to strengthen policies to improve drug quality and safety infrastructures, to strengthen drug testing
laboratories, to adopt e-governance mechanisms for better networking and coordination with State
drug control departments, and to increase human resources to ensure that only safe and effective
medicines of standard quality are available in India. Indeed a clear vision can serve to incentivize
8 | India Pharma Summit 2014-15: Policy Landscape Reforms for Strengthening Indian Pharmaceutical Industry
Figure 3: Manufacturers of WHO list of prequalified Medicinal
Products, As on February 2015
0
50
100
150
200
250
300
350
400
OthersAfricaChinaIndia
NTD
Influenza
Diarrhoea
RH
Malaria
TB
HIV
market development of locally manufactured drugs through robust government actions and policies.
For example, by developing policies to improve processes for the approval of new drugs, clinical trials,
quality standards, as well as the regulation of manufacturing, sale and distribution of drugs, improved
quality of pharmaceuticals can be assured.
To stimulate domestic drug manufacturing, the Department of Pharmaceuticals has formed three task
forces which include a task force on Enabling the private sector to lead the growth of Pharmaceutical
sector, a task force on Medical Devices and Pharmaceutical Manufacturing Equipment and a task force
on Development of capabilities for each Medical Vertical. The Sub-group created by the Department of
Pharmaceuticals on “Policy and Infrastructure Issues concerning the Medical Devices Sector” has
recommended that the government should increase support to the pharmaceutical industry so as
produce domestically and contribute to the “Make in India” campaign.
The sub-groupof the Task Force on Enabling the private sector to lead the growth of Pharmaceutical
sector on “Procedural constraints for promotion of the pharmaceutical industry” has also identified the
need to ease procedures for setting up of pharmaceutical business. Very often start-ups need
approvals of several agencies at central and state levels. The alternative suggested is to explore the
potential of a “single window” clearance/website or a portal with all the licenses/approvals required
and providing forms with links to all the concerned competent/regulatory approvals (e.g. a common
application form (CAF) instead of several different forms for various departments).
Fostering access to good quality pharmaceuticals is critical to attain India’s goal of Universal Health
Coverage (UHC) and thus, coordinated action is needed by the policy makers, relevant actors in health
systems and other agencies, including WHO which plays an important role in supporting countries in
strengthening their regulatory systems of medical products for human use, and in promoting equitable
access to quality, safe, efficacious, and affordable medical products. Evidence shows that
infrastructure development, capacity building of human resources, procurement strategies, policies on
generic medicines, new regulatory frameworks, and government coordination for approvals are crucial
to foster access. Exploring mutually beneficial synergies between national and international
stakeholders; the government, industry, academia, medical profession and consumer groups through a
health system’s approach can usher the way for sustainable initiatives for improved access to
pharmaceuticals; putting India a step ahead to achieve Universal Health Coverage.
Way Forward
9 | India Pharma Summit 2014-15: Policy Landscape Reforms for Strengthening Indian Pharmaceutical Industry
Promoting Production and Technology adoption in Pharmaceutical Enterprises
for meeting National and Global Public Health needs
Background
India is experiencing a rapid health transition, with increasing burdens of non-communicable diseases.
The non-communicable diseases, such as cardiovascular diseases, diabetes, asthma and cancer, take a
bigger toll on developing countries, therefore affordable access to user-friendly versions of existing
generic medicines, and to low-cost versions of newly-developed medicines, for treating those
diseases, will be needed. The quality of all these products will have to be assured. Indian
manufacturers have several strengths such as availability of qualified personnel, strong R&D capability,
strong vertical integration of generic pharmaceutical industry, including R&D and innovation and
process design.
Good-quality Active Pharmaceutical Ingredients (APIs) are inevitable for the production of good-quality
medicines. Ensuring the quality of the API greatly contributes to achieving the objective of building the
quality, safety and efficacy into the product (5).
The Indian pharmaceutical industry exports life-saving drugs to developing countries and also supplies
quality drugs to the rich nations at affordable prices. Efficient production and technology adoption
measures are vital to ensure smooth access to the essential and good quality medicines. This would
augment the capacity of Indian generic pharmaceutical enterprises to meet the supply demands at
National and International levels. These intersecting concerns on access to medicines, technology
transfer and local production have resulted in growing attention to the possibility of international
cooperation to enhance all three issues such as access, technology and production.
Renewed interest in local production arises against the context of increased interconnectedness and
vulnerability to global health threats, a changed global intellectual property regime, growing capacity in
key developing countries to produce and develop medicines, globalization of the pharmaceutical
supply chain, the expansion of developing country pharmaceutical markets, and increased attention to
the challenge of ensuring equitable access to medicines (6).
Access to quality medicines at affordable prices is a major concern at the national levels and in the
South-East Asia region for which there is a need to develop lasting solutions. For this it is necessary to
augment the capacity of Indian generic pharmaceutical enterprises to meet the demand nationally and
globally. The World Health Assembly (WHA) Resolution 61.21 emphasized this issue and identified a
number of deliverables under Global Strategy and Plan of Action on public health, innovation and
intellectual property (GSPA- PHI) to promote new thinking on innovation, transfer of technology and
access to medicines' (7).
12 | India Pharma Summit 2014-15: Policy Landscape Reforms for Strengthening Indian Pharmaceutical Industry
Promoting Production and Technology adoption in Pharmaceutical Enterprises for meeting National and Global Public Health needs
Current Landscape of Activities related to Local production &
Transfer of Technology: International Experience
The Doha Declaration has served as a catalyst for developing coherence at the international level. In
conjunction with its role of making public health issues a central focus of work carried out by the WTO
on IP and international trade, the Doha Declaration has been taken up in a series of World Health
Assembly (WHA) resolutions on ensuring accessibility to essential medicines and public health,
innovation and Intellectual Property(7).
13 | India Pharma Summit 2014-15: Policy Landscape Reforms for Strengthening Indian Pharmaceutical Industry
Figure 4: Public Health Innovation and Intellectual Property, 2011
Local production and access to essential medical products: A framework for improving public health
Policy
Industrial Policy:
• The objective of this policy is to
develop a viable local industry that is competitive, reliable innovative,
productive and responsible.
• Innovation aims for technological
change and invests in research and development.
• Competition offers prices
• A productive industry contributes to
national economy
Healthy Policy:
• The objective of this policy is to
promote health for all through
universal coverage in terms of p r e v e n t i o n , t r e a t m e n t a n d
rehabilitation.
• Universal access can be achieved
through public sector supply chain or social protection programmes
• Effective regulations for quality assurance
• Uninterrupted supply of essential products
Shared Goals
• Strategic selection of essential m e d i c a l p r o d u c t s fo r l o c a l
production.
• Pricing of locally-produced products that governments and people can afford.
• Str ict compl iance to qual i t y
staandards by the manufacturers and effective national regulatory
authorities.
• Health security-an uninterrupted
supply of essential medicines.
• Innovation for development of products that are more suitable for
conditions.
Direct support to reduce cost of manufacture:
• Grants, subsidies and soft loans
• Provision of land, tax and duty
exemptions for imported inputs for local production of essential medical products
I nd i r ec t suppo r t fo r l oca l production:
• Invest in strengthening regulation of
national medical products;
• Develop national priority lists of medical products;
• Improve the financing of health
services for expanding the domestic market;
• Encourage regulatory
harmonization;
• Introduce appropriate pricing policies;
• Facilitate relevant transfer of technology and others
Government Support
Source: Public Health Innovation and Intellectual Property, World Health Organization, 2011
The local production of drugs in developing countries has long been seen as a potential way to
increase access to medicines and improve public health. At the same time, such production also held
the possibility of supporting other policy goals such as economic development, industrialization and
accelerated technological capacity. The potential importance of local production was recognized in the
2008 WHO Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property
(GSPA-PHI), which points to local production of pharmaceuticals as a key area for investment in
Element 3 and focuses on health-related technology transfer in Element 4.
Domestic Landscape of Activities related to Production and Transfer of Technology in Pharma Enterprises
Although India, China and Brazil have been and continue to be significant producers and suppliers of
cheaper medicines that presently serve the needs of their local markets and much of the developing
world, the pharmaceutical sectors in these countries are transforming. New empirical work shows that
as firms expand and compete in the global economy, their product portfolios are becoming more
geared towards the more stringently regulated markets in industrialized countries.
Local production may promote access to medicines. This would be achievable through a) Increased
price-based competition in the market, contributing to ensuring lower prices of drugs and greater
affordability b) Local firms are not limited to incremental innovation, but also produce new products
that meet both local and international needs c) Efficient and widespread distribution networks and
pharmaceutical supply chains controlled by many local companies enhance access by populations,
especially in rural areas.
Indian pharmaceutical companies were confronted with a new legal regime starting in January 2005
that significantly altered the competitive landscape. Driven by the change to a product patent regime
and the opportunities offered in the international market, the mindset of Indian companies towards
research has altered. Indian companies are shifting their focus to innovative research that is,
developing non -infringing processes, New Chemical Entities (NCEs), Novel Drug Delivery Systems
(NDDS), Biopharmaceuticals etc. Thus Indian drug companies have started to invest more in research
and development to produce their own patented formulations, or to affiliate themselves with large
Western pharmaceutical companies and become outsourcing centres for some of those firms'
activities, such as clinical trials (8).
Simultaneously, Indian firms are expanding their overseas sales of existing generic drugs. To that end,
some have already established production facilities and equipment that meet regulatory standards in
the US and elsewhere. Some Indian companies have also begun purchasing foreign pharmaceutical
firms to improve their access to overseas markets and develop new profit streams.
To take forward the need for promoting new thinking on innovation, transfer of technology and access
to medicines, WHO while developing the Regional Framework for WHO Global Strategy and Plan of
Action on Public Health, Innovation and Intellectual Property (GSPA ) had conducted a secondary data
analysis of Indian pharmaceutical enterprises based on census data from Ministry of Micro, Small and
Medium Enterprises (MSME). In order to develop an assessment tool for promoting access to quality
generic medical products including drugs, pharmaceutical equipment and devices, WHO is at present
conducting a survey of pharmaceutical enterprises in India with the following objectives: (a) to identify
measures needed to promote production and technology adoption/transfer for supply of quality
medical products (b) to develop networks for promoting access to medical products at national and
global levels and (c) to identify areas/mechanisms for the Indian Government and WHO to perform a
supporting role. The results of the survey will aid in policy options and interventions in consultation
with the national stakeholders and ministries.
14 | India Pharma Summit 2014-15: Policy Landscape Reforms for Strengthening Indian Pharmaceutical Industry
Way Forward
As the disease burden shifts and evolves, so does the demand for new, adapted and more effective
medical technologies. A characteristic aspect of access is the distinct need to incentivize research to
address hitherto unmet needs - what are termed neglected diseases. The widespread and equitable
health impact of new technologies cannot be achieved without ensuring appropriate means of access
to finished products. This would entail incentivizing production in pharmaceutical enterprises, building
their capacity, supporting research & development, creating pharma enterprises clusters, industry
academic linkages, product development partnerships and ensuring access to financial capital (9).
Focus must be given on assuring treatment access at affordable prices for diseases prevalent in our
country including impetus for creating clusters of innovation for both pharmaceutical and biologic
segments and reducing regulatory complexity for biosimilars & vaccines.
The success in international convergence achieved in API Cooperation needs to be replicated in the
broader area of pharmaceuticals. There is a larger than ever convergence in activities amongst
international partners and regulators vis-à-vis inspections, especially in the area of APIs.
There is a widespread interest in identifying long-term sustainable measures to improve access to
essential pharmaceuticals in developing countries and renewed attention to local production strategies
as one possible avenue of achieving this goal.
The key pillars to accomplish this goal are mentioned below:
15 | India Pharma Summit 2014-15: Policy Landscape Reforms for Strengthening Indian Pharmaceutical Industry
Information and research: There is a clear need for improved information about ongoing
initiatives to provide a stronger evidence base for policy analysis and recommendations.
Technology transfer: There is ample opportunity and a need to explore technology transfer
for local production of a broader spectrum of products. Creative ways of inducing the
transfer of more advanced technologies, such as for medical devices and biotechnology
products, should be explored.
Public policies: International actors can play an important role by connecting local producers
to the relevant global networks, which may play a critical role in accessing the relevant
technology in imperfect technology markets, and facilitating the development and further
strengthening of such networks.
Capacity building: There is widespread agreement that mid- to long term investment in
building the capacity of local manufacturers and national drug regulatory authorities is
needed.
Background
Indian medical device industry is worth approximately USD $ 3 billion and contributes to 6% of India's
US$ 40 billion healthcare industry. It is fast growing at Compound Annual Growth Rate (CAGR) of
15%(10). India is one of the top twenty markets for medical devices in the world and is the fourth
largest market in Asia after Japan, China and South Korea (11). It presents an exciting business
landscape and opportunities for both multi-national and domestic players. The medical devices industry
is quite wide with more than 14,000 different product types as per the Global Medical Device
Nomenclature (GMDN)(12).
The achievement of health-related development goals, including the Millennium Development Goals
depend upon proper manufacturing, regulation, planning, assessment, acquisition, management and
use of medical devices which are of good quality, safe and compatible with the settings in which they
are used.
The United Nations Commission which was conducted for Life-Saving Commodities for Women and
Children aims to increase access to life-saving medicines and health supplies for the world's most
vulnerable people by championing efforts to reduce barriers that block access to essential health
commodities. The commission has made 10 recommendations to increase access to 13 essential,
overlooked commodities in four categories (reproductive health, maternal health, newborn health, and
child health)(13).
World Health Organization (WHO) defines 'Medical device' as any instrument, apparatus, implement,
machine, appliance, implant, reagent for in vitro use, software, material or other similar or related
article, intended by the manufacturer to be used, alone or in combination, for human beings, for one or
more of the specific medical purpose(s) of:
• diagnosis, prevention, monitoring, treatment or alleviation of disease,
• diagnosis, monitoring, treatment, alleviation of or compensation for an injury,
• investigation, replacement, modification, or support of the anatomy or of a physiological
process,
• supporting or sustaining life,
18 | India Pharma Summit 2014-15: Policy Landscape Reforms for Strengthening Indian Pharmaceutical Industry
Regulatory Issues and Challenges for Medical Devices and Diagnostics
• control of conception,
• disinfection of medical devices
• providing information by means of in vitro examination of specimens derived from the human
body; and does not achieve its primary intended action by pharmacological, immunological or
metabolic means, in or on the human body, but which may be assisted in its intended function
by such means(14).
As outlined in the World Health Assembly resolution WHA 60.29, the WHO Department of Essential
Health Technologies, Diagnostics Imaging and Medical Devices aims to ensure improved access,
quality and use of safe and appropriate medical devices(15). WHO is currently working on the Draft
Regulatory Framework on Medical Devices for member states which would be tabled for
consultation by end of the year. The compendium and list of various technical documents
p r ov i d e d by t h e W HO M e d i c a l D ev i c e Te ch n i c a l S e r i e s c a n b e v i ewe d a t
http://www.who.int/medical_devices/brochure_final_web.pdf?ua=1.
19 | India Pharma Summit 2014-15: Policy Landscape Reforms for Strengthening Indian Pharmaceutical Industry
Figure 5: Medical Device Development, WHO Medical Devices, Policy Access and Use Unit
Essential Medicines and Health Products Department, Health Systems & Innovation Cluster, 2014
Outcome
• Effective,
• Safe,
• Quality
• Appropriate,
• Affordable
• Accessible,
• Available,
• Acceptable,
Medical Devices
• Regulation
•
•
• Management
Innovation
Assessment
ProcessResources and Policies
• Human resources
• Financial resources
• Policies
The Regulatory Systems Strengthening (RSS) Team of the Department of Essential Medicines and
Health Products (EMP) at WHO HQ had launched an International Consultation on Regulatory System
Strengthening. This included not only the assessment of national regulatory authorities (NRAs) and
tools for assessment, but also the capacity building programme and the way forward to meet
emerging challenges and the growing interest for regulation of medicines and health products
including biologicals, vaccines, blood, diagnostics, and medical devices.
Medical devices are essential for safe and effective prevention, diagnosis, treatment and rehabilitation
of illness and disease. Ministry of Chemicals and Fertilizers, Department of Pharmaceuticals, has
constituted a Task Force in the Department of Pharmaceuticals to identify issues related to the
promotion of domestic production of high – end medical devices and pharmaceuticals manufacturing
equipment in the country.
20 | India Pharma Summit 2014-15: Policy Landscape Reforms for Strengthening Indian Pharmaceutical Industry
Figure 6: Difference in Health care needs across the globe, WHO Medical Devices, Policy Access
and Use Unit Essential Medicines and Health Products Department, Health Systems
& Innovation Cluster, 2014
Changing Patient Profit
Increased life expectancy andaging population
Increasing incidence of lifestyle/non communicable diseases
Rising purchasing powerdisposable income
Changing Medical TechnologyLandscape
Faster upgradation of existingtechnology and global new
product Innvovation
Evolution of India as a medicaltourism hub leading to demand
for world class equipments
Growing awareness amongstproviders & consumers onadvancements in medical
technology
Improving Healthcare Delivery &Financing
Increasing competition with theadvent of large private sector
healthcare providers
Increasing trend of seeingaccreditation leading to rise in
technology investments
Rising health insurance leading toincreased coverage of high cost
treatment
A sub group was constituted under the task force to ascertain present status of the medical devices
and equipment industry in the country along with the share of domestic production and imports in the
different categories of medical devices and equipment used in manufacturing of pharmaceuticals and
to review the present situation of demand in the country for medical devices and pharmaceuticals
manufacturing equipment .
The Indian medical device industry is expected to continue growing with the demographic changes
such as aging population, increased life expectancy and the expanding markets in developing
countries. At present, there are approximately 1000 domestic firms primarily manufacturing low
technology products. Recently, the companies have expanded operations to produce medium-end
medical devices also. The industry is turning technology intensive thereby producing high quality and
cost-effective medical devices(11).
On the other hand, the present Indian medical device industry landscape is primarily import driven
with imports contributing close to 75% of the market (16). Along with the challenges due to
inadequate quality standards setting, time delays and other related hassles, new product development
has become a hindrance making the domestic medical devices business challenging for the industry.
Current scenario of medical devices market in India
21 | India Pharma Summit 2014-15: Policy Landscape Reforms for Strengthening Indian Pharmaceutical Industry
Figure 7: Key Growth Drivers for Medical Technology Industry in India, Adapted from Medical
technology industry in India Riding the growth curve, Deloitte and Confederation of
Indian Industry (CII). (July 2010).
Kay Growth Drivers for Medical Technology Industry in India
Under the recently launched 'Make in India' project by Honorable Prime Minister of India, the need to
raise global competitiveness of the Indian manufacturing sector is imperative for the country's long
term-growth. The 'Make in India' program identifies following important growth drivers for Indian
Healthcare Industry. Few of them pertinent to Medical Technology Sector are,
• Fast-developing clinical capabilities with the country becoming a popular destination for clinical
trials, contract research and manufacturing activities.
• Increase in India's patient pool to over 10 % in the next 10 years, mainly due to the rise in
population and rise in lifestyle diseases.
• Over USD 200 billion to be spent on medical infrastructure in the next decade.
• Rising levels of education to increase acceptability of medical technology products (17).
National Health Systems Resource Center (NHSRC), a technical support institution under Ministry of
Health & Family Welfare, has provided technical support to Department of Commerce towards setting
up of medical devices testing laboratories which would cater to domestic manufacturers. This would
help country produce good quality medical devices at much lower costs.
With the Government encouraging the growth of medical devices sector in the country, and 'Make in
India' drive pushing industrial growth, it is necessary to put in proportionate efforts in development of
facilities which have infrastructure and technical capability to perform various tests. Keeping in view of
this requirement, WHO Country Office for India in collaboration with the National Health Systems
Resource Centre (NHSRC) has formulated two technical documents, Electrical and Electronic Medical
Devices Testing Laboratory and Biomaterial and Biocompatibility Testing Laboratory for establishment
of medical devices testing laboratories. These report highlights the basic requirements, work flow,
infrastructure and human resources required for establishing medical devices testing laboratory/facility
for testing of electrical and electronic medical devices and as well as biomaterial implants. This may
serve the needs of government agencies, laboratories and research institutions, as well as medical
devices manufacturers in a highly complex technical area of work. Department of Commerce, Govt. of
India has assured its support in establishment of these laboratories at state level to further promote
the 'sunrise sector' of medical devices in India.
Health Technology Assessment (HTA) is an emerging area widely used in many countries for decision
making on health products and systems. Pioneering effort has been made in India to bring HTA to the
forefront. Assessments of over 50 technologies have been completed, compendium of HTAs have
been jointly published by NHSRC and WHO Country office for India. NHSRC and WHO Country Office
have been jointly conducting Health Technology Assessment Fellowships once every six months and
over 250 professionals have been trained so far from across scientific institutions in the country.
Recognizing the work of Division of Healthcare Technology at NHSRC, it has been proposed to
designate the division as a WHO Collaborating Centre for Priority Medical Devices & Health Technology
Policy soon.
22 | India Pharma Summit 2014-15: Policy Landscape Reforms for Strengthening Indian Pharmaceutical Industry
Current Regulatory Status of Medical Devices in India
In India, import, manufacture, sale and distribution of notified Medical devices is regulated under
Drugs and Cosmetics Act, 1940; and Rules, 1945. Regulatory Authority that governs the regulations of
Registration and Import of medical devices in India listed under the Act is Central Drugs Standard
Control Organization (CDSCO) which is headed by Drugs Controller General of India (DCGI). The DCGI
is responsible for handling matters of product approval and standards, clinical trials, introduction of
new medical devices, and import licenses for new Notified Medical Devices.
The Act and Rules seek to:
• Regulate the import, manufacture, distribution and sale of Notified Medical Devices.
• Ensure availability of standard quality Notified Medical Devices to the consumer (18)
There are certain medical devices which have been regulated by deeming these medical devices as
'drugs'. These few medical devices were regulated by the Drugs and Cosmetics Act, 1940 and the
rules framed thereunder viz. Drugs and Cosmetics Rules, 1945. Medical Devices and Diagnostic kits
were categorized as notified and non-notified. It is crucial to understand the regulatory requirement for
registration and import of these two categories of products. A list of the 'Notified Medical Devices' are
given below and it has been clarified by the authorities vide notification that any device that does not
appear in the said list of Notified Medical Devices, does not require any registration certificate or other
approvals from the authority.
23 | India Pharma Summit 2014-15: Policy Landscape Reforms for Strengthening Indian Pharmaceutical Industry
Table 1: Notified Medical Devices under Drugs and Cosmetics Act and Rules
Notified Medical Devices
1. Disposable Hypodermic Syringes SLA
2. Disposable Hypodermic Needles SLA
3. Disposable Perfusion Sets SLA
4. In Vitro Diagnostic Devices for HIV, HBsAg and HCV. SLA
5. Cardiac Stents. SLA &CLAA
6. Drug Eluting Stents. SLA & CLAA
7. Catheters. SLA & CLAA
8. Intra Ocular Lenses. SLA & CLAA
9. I.V. Cannulae SLA & CLAA
10. Bone Cements. SLA & CLAA
24 | India Pharma Summit 2014-15: Policy Landscape Reforms for Strengthening Indian Pharmaceutical Industry
Table 2: Products regulated as 'Drugs' under Drugs and Cosmetics Act and Rules
Notified Medical Devices
11. Heart Valves. SLA & CLAA
12. Scalp Vein Set. SLA & CLAA
13. Orthopedic Implants. SLA & CLAA
14. Internal Prosthetic Replacements SLA & CLAA
SLA – State Licensing Authority. CLAA – Central Licenses Approving Authority.
Following products are regulated as ‘Drugs’ under Drugs and Cosmetics Act and Rules
Blood grouping sera
Ligatures, Sutures, Staples
Intra uterine devices (Cu-T)
Condoms
Tubal rings
Surgical dressing
Umbilical tapes
Blood / Blood component bags
Manufacture for sale of Disposable Hypodermic Syringes, Disposable Hypodermic Needles,
Disposable Perfusion sets and In-vitro Diagnostic Devices are regulated by the concerned State Drug
Licensing Authority only. A single application has to be made to SLA for obtaining manufacturing
license. Manufacture of notified medical devices (Under CLAA Scheme) for sale in India, License in
Form-28 is required under Drugs and Cosmetics Rules. The Rule 76 of Drugs and Cosmetics Rules
describe the information/data required for grant of manufacturing license For CLAA items, 3 sets of
applications have to be made (SLA, Zonal Office and CLAA). There will be Joint inspection for CLAA
items; including the Drugs Inspectors from CDSCO (Zonal offices) and State.
For marketing of imported medical devices in India, Registration Certificate in Form-41 and Import
License in Form-10 is required under Drugs and Cosmetics Rules. The Rule 24-A, 25-B, 27- A and28-A
of Drugs and Cosmetics Rules describe the information/data required for grant of registration
certificate.
Schedule M -III of the Rules prescribes GMP guidelines for manufacture of Notified Medical Device in
India. Every company manufacturing Notified Medical Devices in India has to comply with the
provisions of Schedule M-III as a condition of its manufacturing license; else it may lead to cancellation
or suspension of the manufacturing license.
The Drugs & Cosmetics Act amendment bill is the recent initiative by the Ministry of Health and
Family Welfare, Government of India to enable a robust regulatory landscape in India for medical
devices and to create a proper regulatory environment for medical device industry. The amended act
would regulate the import, manufacture, distribution and sale of drugs, cosmetics and medical
devices, to ensure their safety, efficacy, quality and conduct of clinical trials and for matters connected
therewith or incidental thereto.
As per the proposed Act, the central government by notification, would constitute a Board to be called
the Medical Devices Technical Advisory Board to advise the Central Government and State
Governments on technical matters pertaining to medical devices, arising out of administration of this
Act and to carry out other functions assigned to it by or under this Act.
The Central Government may constitute a consultative committee to be called the Drugs, Cosmetics
and Medical Devices Consultative Committee to advise the Central Government, the State
Governments, the Drugs Technical Advisory Board and the Medical Device Technical Advisory Board on
any matter tending to secure uniformity throughout India in the administration of this Act (19). In
addition to updated definitions, the new legislation would simplify import procedures and affect
change across many areas including: manufacturing, sales, distribution and clinical trial of medical
devices.
The amendment in respect of specific labeling requirements for medical devices have been made vide
GSR 690 (E) dated 25.09.2014 in the Rule 109A of the Drugs & Cosmetics Act & Rules.
According to the new draft of the Drugs and Cosmetics act, clinical trial means,' the systematic clinical
investigation or study of an investigational medical device or a new medical device in, or on human
participants to assess the safety or performance or effectiveness of the medical device' (19).
There is a need for additional resources for investment in infrastructure and human resources for
training and skill up gradation. Actions are to be taken to evolve medical technology clusters with
common facilities for development, calibration, testing, quality control, waste management etc.
Creating an ecosystem for the benefit of small and medium sized enterprises (SMEs) focusing on
medical technology would add to the growth impetus, There should be an increase in the training for
regulatory staff especially at the State Levels to ensure consistent interpretation of regulatory approval
processes.
The Drugs & Cosmetics Act (Amendment) Bill, 2015
Way forward
25 | India Pharma Summit 2014-15: Policy Landscape Reforms for Strengthening Indian Pharmaceutical Industry
'Centers for Excellence' for different categories of Medical devices can be designated to inter-alia
update BIS standards and set up validation facilities with the available International standards and
compliance mechanism. It is recommended that the BIS standards should be made mandatory and an
exercise undertaken by the National Health Resource Centre in the Ministry of Health and Family
Welfare and BIS may also be integrated.
It is recommended by the task force that a committee should be set up with representatives from
medical devices industry and academia. The committee may coordinate with the Health Care Sector
Skill Council under the National Skill Development Council which is also active in the field of
developing skills in the medical device industry (20). Recently, the Government also opened up the
sector to 100% foreign direct investment (FDI). The move will offer the Indian companies to a wider
foreign market.
Post-market surveillance/vigilance is essential to ensure that medical devices in use continue to be
safe and effective. Because of the worldwide increase in the use of medical devices, the ability to
access coordinated and analysed global post-market surveillance/ vigilance data would greatly enhance
medical device safety (21).
The Indian medical device sector continues its upward march of growth and is strongly supported by
India's robust proposed regulatory framework. The new government at center has shown promise and
it is likely that the new law that will overhaul the regulatory framework applicable to medical devices.
26 | India Pharma Summit 2014-15: Policy Landscape Reforms for Strengthening Indian Pharmaceutical Industry
1. Indian pharmaceutical Industry, Executive Summary, Working group paper, Planning commission,
Accessed from
http://planningcommission.gov.in/aboutus/committee/wrkgrp12/wg_pharma2902.pdf
2. Universal Access to Medicines in India: A Baseline Evaluation of the Rajasthan Free Medicines
Scheme. WHO, 2014.
3. WHO List of Prequalified Medicinal Products, Prequalification Programme, Accessed from:
http://apps.who.int/prequal/
4. India's National Regulatory Authority meets international standards for vaccine regulations,
Accessed from http://www.searo.who.int/india/topics/medicines/nra_meet/en/
5. India Pharma Summit , Position Paper: Enhancing India's global Role in Supply of Generic
Medicines, Department of Pharmaceuticals, FICCI and WHO India, 2013-14
6. Pharmaceutical Production and Related Technology Transfer, World Health Organization, 2011.
Accessed from :
7. Local Production of Pharmaceuticals and Related Technology Transfer in Developing Countries: A
series of case studies by the UNCTAD Secretariat, United Nations, New York and Geneva, 2011
8. Indian Manufacturing Industry: Technology Status and Prospects, United Nations Industrial
Development Organization, 2005
9. Promoting access and Medicinal Innovation: Intersections between Public Health, Intellectual
Property and Trade, Joint study by WHO, WIPO and WTO Secretariats, 2012
10. Medical technology industry in India Riding the growth curve, Deloitte and Confederation of
Indian Industry (CII), 2010. Retrieved from
http://www2.deloitte.com/content/dam/Deloitte/in/Documents/life-sciences-health-care/in-lshc-
medical-technology-in-India-noexp.pdf
27 | India Pharma Summit 2014-15: Policy Landscape Reforms for Strengthening Indian Pharmaceutical Industry
11. Growth of Indian medical devices' industry marred by import-export anomaly: Domestic industry
facing competition from China & other countries in Asia-Pacific Study, Assocham, Monday, June
16, 2014, http://assocham.org/newsdetail.php?id=4548
12. The Medical Devices and Equipment Industry, FICCI. (n.d.). 6–8. Retrieved from
http://www.ficci.com/sector/76/Project_docs/Medical_Devices_and_Equipment_Sector_profile.pdf
13. United Nations Commission on Life-Saving Commodities, Medical Devices, WHO, March 2015.
Accessed from http://www.who.int/medical_devices/unclsc/en/
14. Medical Devices, WHO 2015. Accessed from
http://www.who.int/medical_devices/full_deffinition/en/
15. Medical Devices, WHO, August 2014. Accessed from http://www.who.int/medical_devices/en/
16. Executive Summary, Working group paper, Indian pharmaceutical Industry, Planning commission,
http://planningcommission.gov.in/aboutus/committee/wrkgrp12/wg_pharma2902.pdf
17. Concept note - Medical Devices And Plastics Disposables / Implants Industry, Indian Medical
Device Industry conference, “Indian Medical Devices & Plastics Disposables / Implants Industry
2015”: January 9- 10, 2015
18. Current Regulatory status of Medical Devices in India, Central Drugs Standard Control
Organization, Ministry of Health and Family Welfare, Government of India, 2015.
19. Draft Drugs and Cosmetics (Amendment) Bill, 2015, Department of Health and Family Welfare.
(2015). 1(301), 1–42. Retrieved from http://www.cdsco.nic.in/writereaddata/D&CAMENDMENT
BILL(1).pdf
20. Promotion of domestic production of High End Medical Devices and Pharmaceuticals
manufacturing equipments in the country, Task Force Meeting, Ministry of Chemicals and
Fertilizers, Department of Pharmaceuticals, Government of India, January 2015
21. Moorman, B. (2010). Medical Device Interoperability: Overview of key initiatives. Biomedical
Instrumentation and Technology, 44, 132–138. doi:10.2345/0899-8205-44.2.132
28 | India Pharma Summit 2014-15: Policy Landscape Reforms for Strengthening Indian Pharmaceutical Industry
The Department of Pharmaceuticals was created on 1st July 2008 to be a focused Department of Government of India for fostering growth of the Indian Pharmaceutical Industry. The Department has been assigned several functions including inter-alia promotion of Research, Education and Training, Public Private Partnership, international Cooperation, Inter- Sectoral cooperation, Industrial Cooperation, Environment and Hazard Management and Pricing and Availability of Medicines. The Department of Pharmaceuticals discharges their functions through active consultations with stakeholders to formulate new schemes/ proposals/ strategies for promoting growth of the Pharmaceutical Industry.
Established in 1927, FICCI is the largest and oldest apex business organisation in India. Its history is closely interwoven with India’s struggle for independence, its industrialization, and its emergence as one of the most rapidly growing global economies. FICCI has contributed to this historical process by encouraging debate, articulating the private sector’s views and influencing policy.
A non-government, not-for-profit organisation, FICCI is the voice of India’s business and industry.
FICCI draws its membership from the corporate sector, both private and public, including SMEs and MNCs; FICCI enjoys an indirect membership of over 2,50,000 companies from various regional chambers of commerce.
FICCI provides a platform for sector specific consensus building and networking and as the first port of call for Indian industry and the international business community.
Our Vision: To be the thought leader for industry, its voice for policy change and its guardian for effective implementation.
Our Mission: To carry forward our initiatives in support of rapid, inclusive and sustainable growth that encompass health, education, livelihood, governance and skill development.
To enhance efficiency and global competitiveness of Indian industry and to expand business opportunities both in domestic and foreign markets through a range of specialised services and global linkages.
World Health Organization is the United Nations' specialized technical agency for Health. It is an inter-governmental organization and works in collaboration with its member states. WHO's objective is the attainment by all people of the highest possible level of health. Equitable access to essential medicines for priority diseases is one of the requirements for fulfilling the fundamental right to health. WHO's Medicines' Strategy is based on four key objectives: strengthening national medicines policy, improving access to essential medicines, the quality & safety of medicines, and rational use of medicines.
WHO India Country Office collaborates with the Government of India and relevant stakeholders within the framework of the collaborative Country Cooperation Strategy (CCS), to actively support the development and implementation of national health policies, strategies and plans in the area of Essential Medicines & Pharmaceuticals, including access, quality and safety of medicines and impact of intellectual property rights on public health.
Mr. Kawaljeet SinghDeputy Director
FICCI Federation House Tansen Marg, New Delhi – 110001
Email: kawaljeet.singh@ficci.comTelephone: 011-23487355
Dr. Madhur GuptaTechnical Officer-Pharmaceuticals
WHO Country Office for IndiaRK Khanna Tennis Stadium, Safdarjung Enclave
New Delhi – 110029Email: guptamadh@who.int
Telephone: 011-66564800 (23274/23255)
www.ficci.comwww.indiapharmasummit.in
For More Details Contact:
Mr. Raj KumarUnder Secretary to the Government of India
Department of PharmaceuticalsMinistry of Chemicals & Fertilisers
Shastri Bhawan, New DelhiEmail: uspi3-pharma@nic.in
Telephone:011-23071162
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