Regulatory Challenges of Indian Pharmaceutical companies

& Role of Information Technology

With the current scenario of blurring of geographical borders and stringent regulations in many
countries India is foraying into, it is time for the Indian Pharma companies to apply Information
technology applications to understand regulatory challenges beforehand.

Introduction
Globally, one of the most important risks that pharmaceutical industry faces is that of compliance to
extremely stringent process standards of Good Laboratory Practice (GLP), Good Manufacturing
Practice (GMP) and Good Clinical Practices (GCP). The industry is under the vigilance of multiple
regulators that impose high standards, which increases efforts on the part of the industry but also
builds up trust of its clients and the obligation on the regulatory bodies to ensure a healthy supply of
quality drugs at affordable prices to the masses.

Regulatory Challenges in hand

In India the companies manufacturing and exporting drugs not only need to adhere to the standards
imposed by the state FDA, Indian FDA, DCGI, but also standards set by the FDA of the countries to
which the product is being exported. The regime of compliance is becoming stronger as regulators
look for greater compliance from the industry given the mounting consumer pressures, and increasing
healthcare standards.
In addition, regulatory authorities are increasing the scrutiny related to patient safety and compliance
with approved application information. As regulatory departments are challenged to develop global
regulatory strategies, coupled with the corporate desire to launch in global markets early, the need to
understand the regulatory requirements for filing, timelines, what products are approved in which
markets is becoming a critical regulatory need for both industry and regulators. Effective regulatory
information management processes and tools are needed to ensure the organization remains
compliant with its product registrations.

Role of Information Technology in Pharma sector

High competition, less time to reach the market and a highly regulated environment are forcing Indian
pharma companies to adopt advanced and latest IT and automation solutions. In the recent years,
there has been a significant rise in the use of computer related systems in the pharma industry. Many
industries have got most of their operations computerized. Not just the big pharma companies, but
also small and medium enterprises utilize automation in one form or the other. Software systems are
being increasingly accepted as an essential part of a modern and progressive pharma industry.

In the area of pharmacy, there are volumes of data with respect to drug formulations, chemical
compounds for drugs, details of clinical trials, etc. which can be stored using IT. Pharmaceutical
companies are using IT across various functional areas like R&D, QC, QA, Clinical Development,
Manufacturing and Supply Chain, Sales, Marketing and Corporate Management. Not only the
industries, but also hospital, clinical and community pharmacies are acknowledging the importance of
IT solutions. Information Technology is used to assist the delivery of pharmaceutical care, medication
regimen adherence, patient safety, measurement of therapeutic outcomes and patients' self-care
management.
Today, a number of software solutions are commonly used in the pharmaceutical industry. Some of
the popular ones are: Enterprise Resource Planning (ERP), Laboratory Information Management,
System (LIMS), Sales Force Automation (SFA), and Customer Relationship Management (CRM)
With all the above applications, huge amount of data is now available in the organization, but the key
challenge is to provide right information at right time to top/senior level management which can play
a vital role not only in decision making but also in identifying risks in time at all department levels.

IT applications should be able to address key questions:

What is my comfort level on regulatory compliance?

Can I identify regulatory issues beforehand to act in time?

How do I assess my business and quality risk?

Where is the information available I am looking for?

How much time it takes to gather information?

What is the level of predictability of regulatory risks?

These questions have made IT companies to think on bridging gap between huge amounts of data
from various software applications and report to users in desired format with less implementation
time. Let us now know some of the salient features of such applications.

Salient features of IT applications in Regulatory Environment:

Fulfill a significant portion of senior managements information needs especially in terms of

regulatory aspects.

Depicts the broad status of regulatory and operational risks beforehand.

Enable both top level view as well as microscopic view of information.

End Users can View, Critical, Major and Minor organizational risks in defined terms.

Allows user to explore ground level data and helps in analyzing reasons and instances of
occurrence.

Extensive interactivity across all other IT applications and drive the information to single
platform for end user.

Escalation of key failures, alerts management to required level of management on hierarchical

level on daily basis

User-friendly interface design, easy-to-use, is satisfying and engaging to use.

Able to define thresholds dynamically based on regulatory aspects which are dynamic by their
nature.

Lessens the dependency on department heads/seniors for crucial information needs, which in
turn saves time and money instantly.

Provides clear insight on areas requiring urgency, important or long term management
attention.

Quick search filters, automated alerts on dynamically defined criteria to authorized users from
all the departments.

Customization of dashboard as per end user requirement.

Supports decision making activities with low turnaround time.

Representation of information through Bar diagrams, Pie diagrams and line graphs.

Information is categorized on the basis of department level detailed information.

Possibility of close intervention to the level of detail.

Able to analyze huge amount of information maintained at all levels of plants and corporate
offices located globally.

Paradigm shift from relying on people for critical information on time.

SUMMARY
Involving reporting IT applications will have a right first time approach and will play a very important
part in coordinating organizational endeavors with regulatory demands, helping to maximize the costeffective use of the companys resources.
Senior Management professionals can now rely on a single application instead of navigating through
plethora of applications available at various departments and such applications are able to provide
them with both broad level view and microscopic view to the level of detail and presenting the
information as immediate action items with critical, major and minor risks with dynamic thresholds
covering all areas in the company.

It can be a timely move to implement such innovative IT applications among Indian Pharma
Companies.

By Vishwanath, M.B.A

About Author:
Vishwanath, M.B.A., is member of Business Solutions/ Analyst Group at Goose Technologies
specializing in business analysis, consulting and implementing IT solutions to Pharmaceutical Sector.
He plays a key role in identifying innovative IT related solutions to address business problems faced
by Pharmaceutical sector in terms of cost effectiveness and low turnaround time.