India Pharma Summit 2014-15 - searo.who.int Pharma Summit 2014-15 ... environmental requirements or regulatory necessities but the issues ... AIDS, Tuberculosis, Malaria,

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


“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

Overview of the Indian Pharmaceutical

Sector Introduction

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.


Critical Verticals to Foster Access to Pharmaceuticals at National and

International level

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).


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).


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


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


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).


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).


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.


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:


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.

Regulatory Issues and Challenges for Medical Devices and Diagnostics

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,


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.


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.


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


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.


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.


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


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


'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.


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


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


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: [email protected]: 011-23487355

Dr. Madhur GuptaTechnical Officer-Pharmaceuticals

WHO Country Office for IndiaRK Khanna Tennis Stadium, Safdarjung Enclave

New Delhi – 110029Email: [email protected]

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: [email protected]

Telephone:011-23071162

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