Saturday, September 26, 2009


The pharmaceutical biotechnology
and medical device research and development
industries are among the most highly regulated
industries in the country. As India is growing very
rapidly in pharmaceutical sector, there is a need of
regulatory affairs professionals to cater the current
needs of industries for the global competition.
Regulatory affairs professionals are the link
between pharmaceutical industries and world wide
regulatory agencies. They are required to be well
versed in the laws, regulations, guidelines and
guidance of the regulatory agencies. There is a
growing need to incorporate the current
requirements of pharmaceutical industries in the
standard curriculum of pharmacy colleges to
prepare the students with the latest developments
to serve the industries. The present article
discusses the regulatory education and its need,
learning resources, courses available, syllabus
contents, and job opportunities in regulatory affairs.
I Introduction
As the pharmaceutical industries throuhout
the world are moving ahead towards becoming
more and more competitive, these are realizing that
the real battle of survival lies in executing the work
by understanding the guidelines related to various
activities carried out to give an assurance that the
process is under regulation. Pharmaceutical
Industry, being one of the highly regulated industries,
is in immense need of people than ever before who
are capable of handling issues related to regulatory
affairs in a comprehensive manner.
II Regulatory Affairs Education
The person indulging in the regulatory affairs
must be familiar with all the guidelines, guidances
and regulatory documents. He should have a

thorough understanding of a particular regulatory
document which has been drafted. Such people
are the primary communication link between the
company and worldwide regulatory agencies such
as USFDA1 (United States Food and Drug
Administration) and European Union of Drug
Regulatory Affairs (EUDRA).
A number of organizations such as the
Regulatory Affiars Professional Society (RAPS), the
Drug Information Association (DIA), the Food and
Drug Law Institute (FDLI) and international
organizations such as the European Society of
Regulatory Affairs play a vital role in providing
relevant information. Commercial training
companies such as Parexel-Barnett and the
Pharmaceutical Education and Research Institute
(PERI) conduct meetings on the regulatory affairs,
which would be helpful to the professionals.2
III. Institutions in India offering Regulatory
Affairs as one of the subjects in PG Course
A very few colleges and universities throughout
the world are offering `Pharmaceutical Regulatory
Affairs’ as one of the subjects.
In India, so far only two universities Guru
Jambeshwar University, Haryana and Manipal
College of Pharmaceutical Sciences, Manipal,
have initiated Such an effort. The curriculum deals
with the USFDA and EUDRA guidelines concerning
filing for New Drug Applications and Abbreviated
New Drug Applications; FDA, International
Conference on Harmonisation (ICH), EUDRA and
Pharmaceutical Inspection Convention (PIC)
guidelines for various operational activities;
Intellectual Property Rights such as Patents, Copy
Rights, Trademarks; etc for patenting.

In general, the curriculum comprises of
introductory foundation that outlines the health care
product research, development process and the
regulatory oversight of the complex processes.
There are both part-time and full-time courses
available for the subject. Part-time courses are
suitable for the professional who will come across
these terms occasionally where as full-time course
is meant for the professional who intends to make
his career in the regulatory affairs3 The course
material is also available in the from of online,
distance learning and interactive CDs mode.
Regulatory affairs position is in highest demand
and fastest growing according to the findings from
a recent survey on employment trends in the clinical
trials industry from CenterWatch4, the reasons
being the lack of candidates who wish to make their
career in this field and increasing turnover of the
pharmaceutical industries.
Pharmaceutical Regulatory affairs is a vast
area, which cannot be taught just with the help of
books or the course materials. The issues related
to the field are often updated so the professionals
find it challenging to keep abreast with the recent
modifications and inclusions.
Incorporating regulatory affairs into the
pharma curriculum will make the pharmaceutical

professionals working in the area of regulatory
affairs grow and keep learning. The professional
will be trained regarding what he is supposed to do
soon after he joins industry unlike the conventional
way of undergoing training under a qualified
regulatory practitioner right after joining the job. This
step will definitely ignite the power of knowledge in
the professionals and make them accustomed with
the working environment.
The recent trend is that the MNCs abroad are
looking forward to India as their preferred destination
for the drug development and research activities. It
gives more weightage to the need of expertise in
the field of regulatory affairs in the post-GATT
implementation age.