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© 2017 Perspectives in Clinical Research | Published by Wolters Kluwer - Medknow 45
Development of medical writing in India: Past, present and
future
Suhasini Sharma
Medical Aairs, Sciformix Technologies Pvt. Ltd., Mumbai, Maharashtra, India
Review Article
INTRODUCTION
Medical writing is the science (and art) of communicating
health and health care‑related information to various
stakeholders. Medical writing, in a broad sense, is not new
to India. Ancient Indian texts such as the
Atharva
Veda
,
Sushruta
Samhita
, and
Charaka
Samhita
are well‑known
medical treatises. However, in a more contemporary sense,
medical writing means preparing scientific documents of
different types for communicating biomedical information to
specific target audiences. It encompasses preparing documents
required for research, development, regulatory approval, and
continuance of drugs in the market (regulatory medical
writing); writing journal articles and manuscripts (publication
writing) that communicate research findings or new medical
ideas to health‑care professionals; and preparing medical
literature for educational and promotional use (medical
communication).
Pharmaceutical medical writing has grown significantly in India in the last couple of decades. It includes
preparing regulatory, safety, and publication documents as well as educational and communication
material related to health and health‑care products. Medical writing requires medical understanding,
knowledge of drug development and the regulatory and safety domains, understanding of research
methodologies, and awareness of relevant regulations and guidelines. It also requires the ability to
analyze, interpret, and present biomedical scientific data in the required format and good writing
skills. Medical writing is the fourth most commonly outsourced clinical development activity, and its
global demand has steadily increased due to rising cost pressures on the pharmaceutical industry.
India has the unique advantages of a large workforce of science graduates and medical professionals
trained in English and lower costs, which make it a suitable destination for outsourcing medical
writing services. However, the current share of India in global medical writing business is very small.
This industry in India faces some real challenges, such as the lack of depth and breadth in domain
expertise, inadequate technical writing skills, high attrition rates, and paucity of standardized training
programs as well as quality assessment tools. Focusing our time, attention, and resources to address
these challenges will help the Indian medical writing industry gain its rightful share in the global
medical writing business.
Keywords: Medical communication, medical writing in India, outsourcing, regulatory writing challenges,
safety writing, writing skills
Abstract
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DOI:
10.4103/2229-3485.198556
Address for correspondence:
Dr. Suhasini Sharma, Sciformix Technologies Pvt. Ltd., Akru Soech Park, 2nd Floor, Crossroad No. 21, MIDC, Andheri (East), Mumbai ‑ 400 093,
Maharashtra, India. E‑mail: suhasini.sharma@sciformix.com
How to cite this article: Sharma S. Development of medical writing in India:
Past, present, and future. Perspect Clin Res 2017;8:45-50.
This is an open access article distributed under the terms of the Creative Commons
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Sharma: Medical writing in India
46 Perspectives in Clinical Research | Vol 8 | Issue 1| January‑March 2017
Medical writing is critical for the pharmaceutical and
health‑care industry for approval, continuance, and promotion
of their products. It is also extremely important for the medical
profession for enhancement and communication of knowledge,
propagation of new ideas, and betterment of therapeutic
practices. For patients and the general public, it is the source
of all health‑related knowledge, information, and education.
Thus, in modern times, medical writing is a very important
instrument for communicating vital information that helps us
lead a healthy, meaningful life.
Globally, a large part of pharmaceutical medical writing is
still done in‑house by companies themselves. However, a
compelling need to gain efficiencies and reduce costs in the
last couple of decades has prompted the pharmaceutical
industry to look at “outsourcing” as a viable option for some
of its noncore activities. The CenterWatch survey on the
pharmaceutical services industry reported that medical writing
is the fourth most frequently outsourced clinical function, and
its market size had doubled in the period of 2003–2008.[1]
Although much of this outsourcing of clinical services occurs
to service providers within the developed regions of the USA
and Europe, countries such as India have gained from this trend
and have been able to capture a foothold in this industry. It is
estimated that the cost of generating medical writing in India
is around 40–60% of the cost in the developed markets of
the USA and Europe, and around 10–20% lower than that in
other emerging economies.[2] This cost advantage, in addition
to its large pool of science graduates trained in English, gives
India a substantial advantage over similar emerging economies
in the medical writing business.
Medical writing as a service industry began in India around
2005 and has grown steadily since then. It has tremendous
growth potential, although it faces some unique challenges
and issues. This article looks at the spectrum of contemporary
medical writing in India and how it began and grew to its
current size and state. It also discusses what the challenges
faced by the medical writing industry in India today are that
impact its growth potential, and it tables some thoughts on
how to overcome these challenges.
THE SPECTRUM OF MEDICAL WRITING
The spectrum of contemporary medical writing spans from
the most regulated, structure‑driven common technical
documents such as clinical study reports (CSRs), clinical and
nonclinical overviews and summaries, research documents,
namely, clinical study protocols, investigational brochures (IB),
or product labels such as Summary of Product Characteristics
(SmPC or SPC) to the relatively nonregulated, less‑structured
Medical
Communication
such as training and promotional
materials, publications, and web content [Figure 1]. The
former, regulation‑driven documents are required for
regulatory submission in support of approval or maintenance
of health‑care products, and this kind of medical writing is
Figure 1: The spectrum of medical writing
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Sharma: Medical writing in India
Perspectives in Clinical Research | Vol 8 | Issue 1| January‑March 2017 47
known as
Regulatory
Writing
. A specialized subcategory of
Regulatory
Writing
is
Safety
Writing
which includes pre‑ and
post‑marketing aggregate safety reports, benefit–risk analysis
reports, and risk management plans (RMPs) for health‑care
products.
Writing clinical regulatory documents requires a deeper
understanding of human physiology and pathology, how
drugs work (pharmacology), and the drug development
process. Whereas authoring safety documents requires a
specialized knowledge of how drug safety is monitored
and managed, various safety‑reporting regulations and
requirements prevalent in different regions of the world, in
addition to the skill in analyzing and interpreting safety data,
identifying new or potential risks, and planning appropriate
measures to mitigate and manage those risks.
Medical
Communication
is a specialized type of writing that is not
as format‑driven as regulatory writing but requires a greater
degree of clinical and therapeutic understanding in addition
to the ability to present scientific data and arguments in
a logical, convincing fashion. It is more open to creative,
innovative approaches and benefited by the use of multimedia.
An understanding of statistical concepts is an added advantage
for a medical writer.
Thus, medical writing requires a blend of capabilities: Medical
understanding, writing skills, awareness, and the application
of regulatory and scientific guidelines (such as ICH, GVP,
COSORT, and ICMJE); knowledge of company‑specific
templates and style guides; the ability to understand, analyze,
interpret, and present scientific data in the required format;
along with the skill to interact and communicate with all
stakeholders—reviewers, clinicians, statisticians, regulators,
and clients.[3]
THE HISTORY OF MEDICAL WRITING IN INDIA
Pharmaceutical medical writing has been undertaken in
India since the early 1960s, albeit on a much smaller scale
and mostly by and for the use of the local pharmaceutical
industry (or companies). This was mainly for the purpose of
promoting pharmaceutical products to doctors or for training
and informing the medical community and patients on health
and health‑care products. However, medical writing on a large
scale or as a commercial enterprise began much later only after
India signed the TRIPS agreement in 1994 and the new patent
law took effect in 2005.
Medical writing saw a jumpstart in India post the CenterWatch
report of 2008 on the rising demand for outsourced medical
writing services, its market size of almost $700 million at the
time and a growth rate of 15%.[1] By this time, the clinical
trial industry had firmly established its roots in India. Clinical
research organizations (CROs) as well as the information
technology (IT)/business process outsourcing (BPO) industry
started looking at medical writing as a possible extension of
their current work as they were already handling a large amount
of clinical trial data for their clients.
With the advantage of a ready pool of medical and life sciences
graduates trained in English and lower pricing, medical writing
projects started coming to India in larger volumes. The initial
assignments included work at the lower end of proficiency—
assembly of CSRs (rather than actually authoring them),
preparing clinical trial safety narratives (often in set templates),
preparing and updating IBs, generating line listings for CSRs
or safety reports, or conducting data quality checks on reports
authored by other service providers.
Around the same time, another outsourcing industry was
trying to find its feet in India—the pharmacovigilance or
drug safety industry. IT/BPOs and knowledge processing
organizations (KPOs) built large teams of drug safety
professionals and relevant technology platforms (safety
databases) and began offering “Case Processing” services
from India. A natural extension of safety services is preparing
aggregate safety reports, known as periodic safety update
reports (PSURs). A few mature BPOs and KPOs with a
higher degree of safety domain expertise started offering
“safety writing” services—preparing PSURs, Periodic Adverse
Drug Experience Reports, Canadian Annual Reports, IND
Annual Reports, and Annual Safety Reports (ASRs) for
submission in different geographies. This was followed by
Chemistry, Manufacturing, Control reports, stability and
quality documents for approval, and license maintenance of
products globally. Companies that specialized in medical
communication began offering documents of greater
complexity by hiring PhDs and medical professionals in
increasing numbers.
However, despite such a steady growth in the scope and
volume of medical writing work in India, high‑complexity
documents such as clinical trial protocols for developmental
studies, complex CSRs, integrated efficacy and safety
summaries, regulatory briefing documents, publications in
international journals, benefit–risk analysis reports, and
RMPs are still a miniscule part of the medical writing we
do from India.
MEDICAL WRITING IN INDIA—THE CURRENT
SCENARIO
Medical writing has expanded significantly in India since
it began as a commercial activity around 15 years ago.
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Sharma: Medical writing in India
48 Perspectives in Clinical Research | Vol 8 | Issue 1| January‑March 2017
The number of medical writers engaged in different types
of medical writing and employed across various types of
organization (IT/BPOs, KPOs, CROs, and communication
companies) could be in the range of 1000–1500. As of July
2016, the Indian Medical Writers Association (IMWA),
which is an academy of medical writers in India, mentions
a membership of over 1500 on its LinkedIn page.[4] There
are other similar, though smaller, professional bodies with
listed members such as the All India Medical Writers
Association. Many of these writers are pharmacy or life
sciences graduates or postgraduates—some of them even with
PhDs. A sizable number of graduates of alternative systems
of medicine (homeopathy and Ayurveda) have taken up
medical writing as a career and are doing well in the profession.
Allopathic medicine graduates and postgraduates (MBBS
or MDs) have entered the field mainly as medical reviewers
or subject matter experts. Their role is primarily to review
the documents prepared by the writing teams and provide
clinical inputs and medical interpretation of data or prepare
specific sections of documents that require greater medical
insight, such as the benefit–risk analysis of a product. With
the slowdown in the clinical trial industry in India in recent
years, medical writing as a profession seems to have come
into its own, and many life sciences graduates have taken up
careers in medical writing.
There are different types of organizations employing medical
writers in India—both service providers and pharmaceutical
sponsors. A guesstimate based on the author’s industry
insight suggests that of the total pool of medical writers in
India today, a large percentage (60–65%) could be employed
with IT/BPOs, KPOs, or communication companies
(such as TCS, Cognizant, Accenture, Sciformix, Indegene,
Cactus Communications); around 25–35% in CROs
(Quintiles, Paraxel, Icon, Siro Clinpharm, etc.) and 5–10%
may be working in pharma companies (Novartis, Eli Lilly,
Sanofi‑Aventis, GSK, etc.).
Currently, there appear to be two strong medical writing
streams in India—a regulatory writing stream and a “safety
writing” discipline. While regulatory and safety writing
services are primarily offered by the BPOs/KPOs and CROs,
medical communication services (including publication
writing) are offered by specialized companies and are still on a
lower trajectory. Compared to developed markets, the demand
for freelance writers is much less in India.
A major part of the business that the industry currently handles
is from global biopharmaceutical companies. However, we are
also witnessing a rising demand for outsourced medical writing
from Indian pharmaceutical companies who aspire to take
their products to developed and emerging markets globally.
Hence, there is a growing demand for experienced medical
writers who can prepare complex regulatory documents for
global submission.[5]
It has been estimated that India handles 5–7% more regulatory
writing than the USA in volume. However, in terms of revenue,
the figure is much smaller, and globally, a significant part of
writing is still done from high‑cost destinations such as the
USA and Europe, with most being done in‑house.[6] In the field
of promotional medical writing, only a small volume of work
is done in low‑cost regions such as India. The global market
for medical writing was estimated to be around $1.3 billion
in 2013.[6] No hard data exist on the annual volume of the
medical writing business delivered from India. However,
compared to the global medical writing business, this figure
could be small ($50 to $70 million), and there is tremendous
scope for the growth of this business in India, provided we
overcome the challenges we currently face.
CHALLENGES IN MEDICAL WRITING AND
POSSIBLE SOLUTIONS
The medical writing industry in India faces some tough
challenges that need to be addressed if we want to gain further
strength and win more complex writing assignments for India.
These challenges are as follows:
Lack of proficiency in business and technical writing
skills
Even though much of science education in India is in English,
our writing skills in the language are far from adequate. We
tend to use laborious language and long sentences, with less
emphasis on grammar and little regard to punctuation. This
sometimes results in text with unclear or ambiguous meaning
and makes documents too long and laborious to read. There
is also an inability to present scientific data and arguments
in a logical flow, resulting in documents becoming just “data
dumps.” Our “rote” system of education is partly responsible
for this state of affairs. We need to make conscious efforts
to develop better language and data presentation skills in our
writers. Therefore, in addition to screening for these skills at
the recruiting stage, medical writing training programs must
include rigorous courses in business and technical writing.
Inadequate domain expertise with lack of global
experience
Our writers are still new to the field of global medical writing
and relatively inexperienced. They often lack domain expertise
and have to depend heavily on internal and client experts
for providing subject matter expertise. The experience will,
of course, come with more years of writing documents of
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Sharma: Medical writing in India
Perspectives in Clinical Research | Vol 8 | Issue 1| January‑March 2017 49
increasing complexity across different domains. The incubation
period for becoming an expert medical writer in any domain
is long and requires conscious self‑learning. This has to be
supplemented at the organizational level by way of encouraging
writers to attend internal and external training programs in
specific domains, giving them a chance to attend national and
international conferences, and even providing opportunities to
work on‑site at global locations. Moreover, India has a diverse,
internationally trained, and competent pool of academically
oriented practicing physicians. We must utilize this locally
available clinical expertise to supplement our writers, provide
valuable therapeutic insights, and enhance the value of our
high‑complexity documents.
High attrition rate
Medical writing is a growing discipline, and like many young
industries, it is fraught with a high attrition rate of over 15%.
The lure of a better job with a higher salary and a fancy
designation is very tempting, and a little frustration with the
current work setup or a feeling of stagnation can prompt
youngsters to switch jobs. At an individual level, this may result
in the loss of continuity in the development of functional
expertise in the domain. At an organizational level, this results
in the loss of trained resources which can have an impact on
the quality of deliverables. Organizations must keep their
attrition levels in check by creating an enabling workplace and
a work culture that appreciates and rewards employees for their
achievements, gives them opportunities to learn and grow in
their field of interest, and by having compensation policies
commensurate with industry norms.
Quality issues
There has been a consistent perception with global clients that
although we may be good at assembly of documents, there are
many “quality” issues when documents are authored in India.
This is also one of the main obstacles in not getting more
complex writing work done from India. Hence, in addition to
improving our writing skills, we need better tools to monitor
and improve the quality of our writing. However, there are no
standardized quality metrics that can be consistently applied
across various document types. Each type of document has a
specific purpose, with specific data and format requirements,
and needs an appropriate, standardized metric to judge its
quality by way of a specific checklist that will go a long way
toward improving the overall quality of our medical writing.
Paucity of standardized training programs
Medical writing is a skill that can be developed if one has
the basic qualifications and qualities to become a good
technical writer. Unfortunately, there are no standardized
training curricula in medical writing and institutes consistently
delivering such programs in India. We can do a lot here by (a)
setting up certified, industry‑led training programs with
controlled curriculum; (b) providing internship to potential
writing aspirants in reputed companies; and (c) actively
collaborating with global organizations such as the European
Medical Writers Association or American Medical Writers
Association for regular skill enhancement and certification
of our writers.
In summary, medical writing is a fairly young discipline in
India. It is still evolving and will take a few more years to
mature into a true industry. Despite having the advantages of
a large, scientifically qualified workforce trained in English
and low cost of delivery, the quantum of the current medical
writing business delivered from India is a small fraction of
the global business. To capture our due share of that business,
we need to address the crucial challenges currently facing the
industry. Some of the corrective measures are developing
more functional expertise in various domains, honing our
technical and business writing skills, training and rewarding
our writers and providing them opportunities for growth,
designing standardized training and certification programs
in medical writing in collaboration with global organizations,
and evolving better quality standards to improve the technical
quality of documents. We must also leverage the vast clinical
expertise available in India to deliver high‑complexity work.
India has the potential to become a destination for global
medical writing, provided we commit our time, energy, and
resources to address the current challenges by designing
effective and sustainable solutions.
Acknowledgment
The author would like to thank Dr. Chitra Lele,
Chief Scientific Officer, Sciformix Technologies, Dr. Milind
Sardesai, General Manager, Operations, Cognizant India,
for providing industry insights and valuable suggestions, and
Aniket Sharma for editorial assistance in the preparation of
this manuscript.
Financial support and sponsorship
Nil.
Conflicts of interest
There are no conflicts of interest.
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4. IMWA LinkedIn page, Available from: https://www.linkedin.com/
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50 Perspectives in Clinical Research | Vol 8 | Issue 1| January‑March 2017
groups/1864566/profile. [Last accessed on 2016 Jul 23].
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