Ethics in Pharmaceutical

Industry
Presented By:
Namita Amale
01
Hitesh Jadhav
10
Amey Kadam
13
Milind Patil
27
Siddhesh Sonawane 29
Subodh Ujjankar
36

PHARMACEUTICS
Pharmaceutical industry
Sales practices
Guidelines and regulations
1. European Federation of Pharmaceutical
Industries and Associations.
2. Pharmaceutical Research and Manufacturers
of America.
. Indian perspective
1. Among top five pharmaceutical emerging
markets.
2. Highly fragmented industry with
20,000registered units.

Current scenario in India

Tops the charts amongst Indias science based

industries with new technology and drug
manufacturing processes.
India is expected to be the third-largest global generic
active pharmaceutical ingredient (API) merchant
market by 2016, with a 7.2 per cent market share.
In 2012, drug companies from India filed 49 per cent
of the overall drug master filings (DMFs) in the US.
Indian startups focusing on the drug discovery
business.
India looking at policy regulation shift in pharmacy
sector.
Government of India to bring all pharmacy related
departments under one roof.

Ethics in Pharmaceutical
Industry: Ethical behavior
Integrity
Information sharing
Accurate prescription
Transparency
Objectivity
Fairness
Care for and about people

Ethics in pharmaceutical
industry: Unethical behavior

Misleading advertisements
Personal interest
Misguiding prescription
Subjectivity
Partiality
Selling of samples to public
Uncontrolled testing

Revenue of Indian
Pharmaceutical Industry
The Indian pharmaceuticals market is expected to
expand at a CAGR of 23.9 per cent to reach US$ 55
billion by 2020..

Market Shares of Top Indian

Companies

History of the company

GlaxoSmithKline plc(GSK) is a British
multinationalpharmaceutical, biologics,vaccinesand
consumer healthcare company.

As of March 2014, it was the world's sixth-largest

pharmaceutical company.

The company was established in 2000 by the merger

of Glaxo Wellcome and SmithKline Beecham plc.

As of 2 May 2014 it had amarket capitalisationof

79billion.

What went wrong.?

Paxiland Wellbutrinfor unapproved uses and failing
to report safety data aboutAvandia.
In July 2012 GSK pleaded guilty to criminal charges
and agreed to a pay $3 billion to settle the criminal
charges.
GSK paid $1 billion to settle the criminal charges.
The remaining $2 billion were part of the civil
settlement over unapproved promotion and paying
kickbacks.
Bribing doctors,

Final
Verdict !

Why?

When?
How?

EY Survey
At EY, they have conducted a survey among health
care
professionals (HCPs) and pharmaceutical
companies to understand their perspective of the
Medical Council of Indias (MCI) guidelines and the
Department of Pharmaceuticals (DoP) marketing
code.
Carried out a two-part survey, in which100
respondents participated.

Key findings of the survey

Around two-third of the respondents felt that the
implementation of the uniform code of pharmaceutical
marketing practices (UCPMP) would change the manner in
which pharma products are currently marketed in India.
According to the survey, more than 50% of the
respondents are of the opinion that the UCPMPs guidelines
may lead to manipulation in recording of actual sampling
activity.
More than 50% of the respondents indicated that the
effectiveness of the code will be very low in the absence of
legislative support provided to the UCPMP committee.

 An overwhelming majority of the respondents (90%)

felt that Pharma companies in India should focus on
building a robust internal controls system for ensuring
compliance with the UCPMP.
Around 72% of the respondents felt that the MCI was
not stringently enforcing its medical ethics guidelines.
And only 36% of the respondents felt that the MCIs
guidelines would have an impact on the overall sales
of Pharma companies.

Suggestions
Promotion

of prescription drugs should

be made a legal matter.
Safety data should be reported to the
concerned body and must be updated
on a regular basis.
Promotion of only licensed medicines
should be carried out.
Ethical practices to be carried out by
companies and their representatives.
i.e. bribing doctors must be avoided.

Conclusion
Ethics in the area of pharmaceuticals which concern the
pharmacist as a person and the pharmaceutical company
as a corporate body is experiencing evolution, where
pharmacy practice is different today than it was
previously. Pharmaceutical innovation and technology
advancement has shaped the pharmaceutical industry and
pharmacists themselves and the need of solid strong ethics
to be embedded into the pharmacist as an individual which
will then form the organization of pharmaceutical with high
ethical values. Ethics and pharmacy at large must be
sensitive and responsive to an unavoidably
changing environment.