PHARMA POLICY OF GOVT OF INDIA

INTRODUCTION

India's pharmaceutical sector will touch US$ 45 billion by 2020,

according to a major study by global management and consulting firm,
McKinsey & Company. The reasons for this optimism are well founded.
In the period 2002-2012, the country's healthcare sector grew three times
in size, touching US$ 70 billion from US$ 23 billion. India's
pharmaceutical market experienced a similar boom, reaching US$ 18
billion in 2012 from US$ 6 billion in 2005. The report further states that
the Indian pharmaceutical market will be the sixth largest in the world by
2020.

The rise of pharmaceutical outsourcing and investments by

multinational companies (MNCs), allied with the country's growing
economy, committed health insurance segment and improved healthcare
facilities, is expected to drive the market's growth.

India is today one of the top emerging markets in the global

pharmaceutical scene. The sector is highly knowledge-based and its
steady growth is positively affecting the Indian economy. The organized
nature of the Indian pharmaceutical industry is attracting several
companies that are finding it viable to increase their operations in the
country.

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INDIAN PHARMACEUTICAL INDUSTRY

POLICIES & ORDERS

When we talk about pharmaceutical policy, it implies a branch of

health policy that covers various aspects of the pharmaceutical industry
like as the development of new medicines, provision and use of
medications within a health care system, considering both brand name
and generic drugs. Pharmaceutical policies also cover products derived
from living sources referred as, biologics which are different from
chemical compositions, vaccines and natural health products.

Let us discuss the main pharmaceutical policies of India under

the following heads:

Drugs Price Control Order (DPCO): Drugs and formulations

have been subjected to price control from a very long time, almost
3 decades now. The economic reforms presented by the
Government of India in July 1991, targeted the Pharmaceutical
Industry only in 1994 and that too partially. Price control in a large
number of industries has already been abolished.

Intellectual Property Rights (IPR): The Agreement on Trade-

Related Aspects of Intellectual Property Rights (TRIPS) provides
for minimum norms and standards in certain categories of
intellectual property rights which are discussed in this section.

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Pharmaceutical Policy 2002: The basic objectives of

Government's Policy relating to the drugs and pharmaceutical
sector were enumerated in the Drug Policy of 1986. Check in
details the pharmaceutical policy 2002.

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OBJECTIVES OF THE POLICY

Key criteria for the inclusion of policy objectives into the study
were: being frequently mentioned in literature and relevant policy
documents (e.g. Pharmaceutical Sector Inquiry, WHO Nairobi
Declaration) and being identified as objective(s) by the High Level
Pharmaceutical Forum or other key processes; the limitations related to
the scope (too broad objectives or those already captured by other terms)
were the criteria for exclusion.

As a result, the following seven policy objectives were chosen:

Timely access to medicines

Equitable access to medicines
Reward for innovation
Cost-containment / control of pharmaceutical
expenditure/budget
Long-term sustainability (for the health care system)
Promotion of a more rational use of medicines
Increased competition.

HYPOTHESIS AND ENVIRONMENTAL RISK

ASSESSMENT OF PHARMACEUTICALS

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Pharmaceuticals in the environment have

received increased attention over the past decade, as
they are ubiquitous in rivers and waterways.
Concentrations are in sub-ng to low g/L, well
below acute toxic levels, but there are uncertainties
regarding the effects of chronic exposures and there is a need to priorities
which pharmaceuticals may be of concern. The read-across hypothesis
stipulates that a drug will have an effect in non-target organisms only if
the molecular targets such as receptors and enzymes have been
conserved, resulting in a (specific) pharmacological effect only if plasma
concentrations are similar to human therapeutic concentrations. If this
holds true for different classes of pharmaceuticals, it should be possible to
predict the potential environmental impact from information obtained
during the drug development process. This paper critically reviews the
evidence for read-across, and finds that few studies include plasma
concentrations and mode of action based effects. Thus, despite a large
number of apparently relevant papers and a general acceptance of the
hypothesis, there is an absence of documented evidence. There is a need
for large-scale studies to generate robust data for testing the read-across
hypothesis and developing predictive models, the only feasible approach
to protecting the environment.

DATA ANALYSIS

1. For how many years you are practicing as a medical practicener

(Doctor)?
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Less than one year ---------------------------------- 17 per cent

From one to five years ----------------------------- 32 per cent
Five to Ten years ----------------------------------- 36 per cent
More than Ten years ------------------------------- 12 per cent
Can not remember --------------------------------- 03 per cent

Practicing as a medical practicener

Interpretation:
At the initial stage of the research, an attempt was made to understand the
profile of the doctors in terms of their experience in the industry. Great care
was taken to ensure that the sample is adequate and representative of the
universe.
2. Do you agree that Indias pharmaceutical industry is one of the fastest
growing segments of the Indian economy?
Agree -------------------------------------- 43 per cent
Strongly Agree --------------------------- 37 per cent

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Disagree ---------------------------------- 09 per cent

Strongly Disagree ----------------------- 04 per cent
Do not know/ Can not say ------------- 07 per cent

The fastest growing segments of the Indian economy

Interpretation:
Indias pharmaceutical industry is one of the fastest growing segments of the
Indian economy and this is also one of the vital industrial segments which are
directly related to the health of the nation.

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3. Do you agree that the marketing strategy of the pharmaceutical industry

should be different from the marketing strategy in non-pharmaceutical
segments?
Agree ------------------------------------ 50 per cent
Strongly Agree ------------------------- 32 per cent
Disagree -------------------------------- 10 per cent
Strongly Disagree -------------------- 04 per cent
Do not know/ Can not say ---------- 04 per cent

Pharmaceutical segments
Interpretation:
The structure and the dynamics of the pharmaceutical industry are different
from that of other industrial domains. This is what necessitates the
pharmaceutical sector to formulate a unique marketing strategy to suit their
industry requirements and that appears to be different, in practice and
normative sphere, from other industries.

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4. Do you agree that institutional selling is quite prevalent when it comes to

pharmaceutical market in India?
Agree ------------------------------------- 44 per cent
Strongly Agree ------------------------- 30 per cent
Disagree -------------------------------- 10 per cent
Strongly Disagree --------------------- 06 per cent
Do not know/ Can not say ------------ 10 per cent

Pharmaceutical market in India

Interpretation:
In general, business in pharmaceutical market is conducted in two major ways,
that is, either by institutional selling or through trade business. The
respondents were of the opinion that institutional selling is quite prevalent in
the Indian pharmaceutical industry.

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5. Do you agree that the pharmaceutical companies need to use innovative

and better promotional measures for selling their products?
Agree -------------------------------------- 60 per cent
Strongly Agree --------------------------- 37 per cent
Disagree ---------------------------------- 01 per cent
Strongly Disagree ----------------------- 00 per cent
Do not know/ Can not say ------------- 02 per cent

Innovative and better promotional measures for selling their products

Interpretation:
Even though it appears to be a serious industry on which the health of the
nation rests, a deeper understanding of the industry will make it clear that
business practices and sales promotion measures are a common thing and
gradually becoming more aggressive and competitive among the
pharmaceutical companies in India.

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6. Does the Pharmaceutical Company offer gifts to the doctors to influence

their prescriptions in favour of their company medicines?
Yes -------------------------------------------- 95 per cent
No --------------------------------------------- 01 per cent
Do not know/ Can not say ----------------- 04 per cent

Prescriptions in favour of their company medicines

Interpretation:
Pharmaceutical marketing experts are aware that well timed advertising directed
to doctors tends to boost sales of the brand that spent the marketing dollars. In the
case of marketing directly to health professionals, the question is whether
promotion is (as most drug companies claim) primarily information on how the
drug works or is intended to persuade doctors to prescribe the drug more
frequently. The practice of offering gifts to the doctors to influence their
prescriptions is a common strategy among the pharmaceutical companies.

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7. Out of the following which one is more correct when it comes to the
promotional strategy of pharmaceutical companies in the view of the
doctors?
They aim to inform about the product ----------------- 22 per cent
They aim to persuade to purchase --------------------- 60 per cent
Other motives -------------------------------------------- 03 per cent
Do not know/ Can not say ----------------------------- 15 per cent

Promotional strategy of pharmaceutical companies

Interpretation:
The promotional strategy of the pharmaceutical companies is more oriented
towards persuading the doctors to prescribe their products and the patients to
purchase their products than simply to display information on the quality and
availability of the product. This is one criterion which makes the marketing
strategy of the pharmaceutical companies different from that of others.

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8. Do you agree that unethical standards exist in the promotion of

pharmaceutical products in India?
Agree ------------------------------------- 52 per cent
Strongly Agree ------------------------- 20 per cent
Disagree -------------------------------- 20 per cent
Strongly Disagree --------------------- 03 per cent
Do not know/ Can not say ------------ 05 per cent

Promotion of pharmaceutical products in India

Interpretation:
Adherence to ethical standards while pursuing the promotional strategy for selling
their products is a concern in the pharmaceutical industry. It is an accepted fact
that the promotional measure does contain unethical practices. It is for the
government, the industry and the consumers to put a comprehensive effort to
ensure that the practices of unethical standards are withdrawn from the health
industry.

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9. Your recommendation to the industry and government regarding the

promotional strategy of the pharmaceutical companies? You can choose
more than one option.
Implement, improve and monitor legislation ----------------- 74 per cent
Measures to improve the transparency of drug companies marketing
activities ---------------------------------------------- 86 per cent
Stop the practice of gifts to doctors ----------------------------- 67 per cent
Ensure codes of conduct on drug promotion ------------------- 70 per cent
Other measures ----------------------------------------------------- 12 per cent
Do not know/ Can not say ---------------------------------------- 01 per cent

The industry and government regarding

Interpretation:

Whilst the pharmaceutical industry clearly has an important role to play in

tackling the health challenges their involvement in the promotion of medicines
presents a serious conflict of interest. It is equally important that health
professionals have access to independent and up to date advice on medicines so
that they can make informed judgments about the most appropriate medication for
patients.

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10. Do you think that the entry of Multinationals is a Major Challenge to the
domestic Players in the Pharmaceutical Market and are they ready to face
the Challenges of the Foreign Players?
Yes ----------------------------------------------- 36 per cent
No ------------------------------------------------ 54 per cent
Do not know/ Can not say--------------------- 10 per cent

The Challenges of the Foreign Players

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11. What type of Marketing Strategy would you prefer to expand your
Market size?

B2B-------------------------------------------------------------- 23 PER CENT

B2C -------------------------------------------------------------32 per cent
Both -------------------------------------------------------------45 percent

Market size

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12. What type of Marketing Strategy does you as More Profitable?

B2B-------------------------------------------------------------- 24 per cent

B2C ------------------------------------------------------------- 47 per cent
Both ------------------------------------------------------------- 31 percent

More Profitable

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CONCLUSION

Implement, improve and monitor legislation in line with the WHO

Resolution on the Rational Use of Medicines and the WHO Ethical
Criteria for Medicinal Drug Promotion.

Support the provision of independent information on drugs for

consumers and health professionals.

Implement and enforce a ban on gifts to doctors.

Enforce strict sanctions that will deter poor corporate practice in drug
promotion.

Take measures to improve the transparency of drug companies

marketing activities and seriously address the conflict of interest
encountered in drug companies funding of medical education.

Ensuring high standards in the promotion of medicines is important

to consumers health and helps to save money for health providers and
patients. Without proper controls consumers can be subject to misleading
or inaccurate claims and the promotion of expensive branded medicines
that have no greater medical value than cheaper non-branded products.
Whilst the pharmaceutical industry clearly has an important role to play
in tackling the health challenges their involvement in the promotion of
medicines presents a serious conflict of interest.

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