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SALES MANAGEMENT MINOR ASSIGNMENT

UNIFORM CODE OF PHARMACEUTICAL MARKETING PRACTICES

The Indian Pharmaceutical Industry is one of the most rapidly growing science
based industries in terms of remarkable capabilities in both the manufacture and
technology. India being among one of the five pharmaceutical emerging markets has an
average annual growth of 8-9 percent with an approximate worth of $ 4.5 billion. With
more new drug launches, new drug applications, phase II clinical trials taking place this
year the growth can be expected to be 13-14 percent in the future.

Considering the rise in the pharmaceutical sector and to bring about uniformity in
the marketing of these drugs, a Code has been introduced by the Department of
Pharmaceuticals (DoP), Government of India. This code named as Uniform Code of
Pharmaceutical Marketing Practices (UCPMP) was introduced on December 12, 2014
and became effective from January 01, 2015. UCPMP initially set to be a voluntary code
for the Pharmaceutical Industries was then decided to be made as statutory Code when
DoP was urged by the Organization of Pharmaceutical Producers of India (OPPI).
UCPMP is expected to facilitate good marketing practices, increased levels of
transparency and accountability across healthcare industry and remove ambiguity on all
aspects of marketing by the pharmaceutical industries.

The code covers various parameters like the general points to be followed by the
industry, claims and comparisons related to other products, textual and audiovisual
promotional matter, ethical behavior of medical representatives, handling and dealing of
samples, prohibition of gifts, relationship with the health care professionals, mode of
operation, complaint handling , complaint lodging procedure, penalty provisions
pertaining to the UCPMP and self declaration by a Board of Director i.e the executive
head of the pharmaceutical company.

The code prohibits pharmaceutical companies from presenting cash or monetary

incentives to the healthcare professionals on any pretext. Also restricting the provision
of free drug samples to any person not qualified for prescribing the drug this is so as to
maintain ethical sales and prevent any kind of possible drug adversities. Pharmaceutical
companies or their associations are not allowed to extend any hospitality like hotel
accommodation to healthcare practitioners and their family members under any pretext.
They are also not allowed to pay any cash or monetary grants to any healthcare
professional for individual purpose in individual capacity under any pretext.

In terms of the medicinal product there should be balanced, accurate, fair

information provision to the prescriber as well as the consumer either through the
pharmacist or the prescriber not misleading either directly or by implication. The
necessity of the same is because it may cause harm to the consumers. The person
qualified to prescribe a product must be experienced in dealing with that kind of product.
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A person shall not supply a sample of a medicinal product which is an anti-depressant,

hypnotic, sedative or tranquillizer.

When it comes to advertising, pharmaceutical industries are restricted to use

brand names of products of other competitive pharmaceutical industries for comparison
of the product features without taking their prior consent. The precautions while using
and the adverse drug reactions including the side effects and the contra-indications
must be mentioned in order to protect the consumers from the danger that the product
can cause. Mailings and journal advertisements of the medicinal products should not be
designed to disguise its true self. Unless the pharmaceutical industry pays for or
secures or arranges the publication of promotional material in journals, the material
must not match the editorial matter. This material should not contain the photographs or
names of the health care professionals. Misleading advertisements are strictly
prohibited.

As per the Code, it is very important that the Do’s and Don’ts pertaining to the
basic ingredients of the product or the formulation are mentioned on the manual
provided. Similarly there is a declaration in the code to mention the date of
manufacturing of the product and also the date of expiration or the shelf life so that the
people are aware of when to and when not to use the product.

According to the Medical Council of India Ethics Regulations 2002 amended in

2009, medical practitioners are not allowed to receive any gift from any pharmaceutical
company or any allied healthcare organization or the representatives of such
companies/industries. The MCI Ethics Regulations are applicable only on medical
practitioners and not on pharmaceutical Companies. However, the Code has explicitly
introduced the provisions that no gifts, pecuniary advantages or benefits in any kind
may be supplied, offered or promised to persons qualified to prescribe or supply drugs,
by a pharmaceutical company or its agents i.e. distributors, wholesalers, retailers etc.

Further, All the Indian Pharmaceutical Manufacturer associations are under

obligation to upload the Code on their websites. All the details as how the complaint
shall be lodged should also be declared on the website. The present status of the
complaint and what action has been taken on the complaint should remain uploaded for
three years. The Code also provides that in case a pharmaceutical company is not
member of any association or member of more than one association, in such cases the
complaint shall be handled by the Pharmaceutical Industry Association to whom the
complainant has addressed the complain.

Every association is required to have a committee for handling complaint named

as "Ethics Committee for Pharmaceutical Marketing Practices (ECPMP) which shall
consist of 3 members. The Code also provides provision of a review committee for
handling the review of the decisions of ECPMP and such committee is named as Apex
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Ethics Committee for Pharmaceutical Marketing Practices (AECPMP) which shall

consist of 5 members. The complaints that are lodged must be in writing and also the
Complainant should identify himself, identify the company, give the details of the breach
of the code, and also the supporting evidence. An amount of Rs. 1000 has to be paid by
the complainant who is nonrefundable and the associations will elaborate how this
payment is to be made.

The immediate and important impact of UCPMP falls not only on the Board of
Directors of the pharmaceutical company but also on the medical representatives and
the detailers who come in direct contact with the prescribers. They are supposed to be
trained to detail in a way that there is no misconception about the product. Also the
detailing should be ethical and should not be based on corruption, coercion or any kind
of confusion. Absolute clarity about the product and the information regarding it is called
for, first to the healthcare professionals and then to the consumers via the health care
professionals.

The UCPMP is a way in which the Government of India wants to make the
pharmaceutical industries market medicinal products ethically and with uniformity. Even
though this Code is voluntary in nature, however it is explicitly mentioned in the Code
that if this Code is not implemented effectively by pharmaceutical associations or
companies, the Government may consider making it a statutory code. Doctors along
with the pharmacists share as much responsibility for making the Code successful.

When the UCPMP is compared with its US and European counterparts, it is

stringent enough but it lacks clarity in many important aspects. Both US and European
codes are already in place. The UCPMP code in its current format, is as stringent (if not
more) as the US codes. However, it does differ in certain places. For example, the place
of jurisdiction has not been mentioned in the UCPMP. This means, if an Indian
pharmaceutical company is caught flouting the UCPMP code in a foreign country, the
action of Indian ministry is dubious. Also, the penalties of not following the code are not
mentioned.

The code was implemented finally in January after inordinate delay of years, as
the government failed to curb unethical marketing practices and drug promotions by
pharmaceutical companies. Though it had first decided to ban these through a uniform
code in 2008-2009, the exercise was futile as the pharmaceutical associations did not
agree to it. Even after the code kicked in this year, complaints against drug companies
continued with many saying that it existed only on paper as companies aggressively try
to influence prescriptions through several ways. Interestingly, results of a survey
suggests that a majority of pharmaceutical industry is itself in favor of tighter controls by
making the code mandatory. Top multinational companies like Novartis, MSD, Sanofi
and Abbott and domestic companies Sun Pharma , Zydus Cadila , Dr. Reddy’s and Blue
Cross among others have made a commitment to follow ethical marketing practices in
both letter and spirit and want to start a movement and build a pressure on those who
are not following ethical professional practices.