S. Harachand is a pharmaceutical journalist based in Mumbai. He can be reached at
The marketing landscape for phar- maceutical products is unlikely to remainthesamein Indiainthedays
to come. Indications are that the federal
government is all set to enforce uniform
marketing code to ensure ethical marketing practices across the country.
The Department of Pharmaceuticals
(DoP) under the Ministry of Chemicals is
currently reviewing the final draft of marketing rules for pharmaceuticals and the order
announcing the enforcement date is due out
any time now, according to reports.
It is not that India does not currently have
marketing guidelines for pharma products. It
does. However, it is a voluntary system. No
penal provisions exist for violators.
In November 2014, India introduced the
Uniform Code for Pharmaceutical Marketing Practices (UCPMP) and implemented
the first draft for a period of six months
beginning January 1, 2015. Following a review, DoP extended the trial for a year and
brought the medical devices industry under
While extending the voluntary code
again for a second time“till further orders,”
DoP reminded the pharma marketers that
the government would be forced to make
the rules mandatory if the industry failed
to self regulate.
The voluntary rules restricted drug and
device makers from offering hospitality to
any doctor, healthcare professional or their
family. It also proposed medical practitio-
ners bear their own expenses if participat-
ing as a delegate in a CME, conference or
seminar organized by a pharma company.
So far as funding of medical research is
concerned, drug makers can do it through
approved institutions but the details
should be fully disclosed. It listed stringent provisions for promotional activities
and supply of free medicine samples to
doctors, among others.
The government, however, found the
voluntary UCPMP guidelines failed to
deliver as instances of violations became
rampant. Moreover, healthcare campaigners have long been demanding stricter
laws to end the “unholy nexus” between
pharma companies and medical professionals which is proving detrimental to
The new regulations, reportedly, put no
bar on drug makers from holding sponsored trips for medical professionals to
attend educational conferences and scientific workshops, provided the firms keep
all the records including the minutes, expenses and the agenda of such meetings
open for verification.
The draft of the proposals, which has
been worked out after consultation with
the health ministry, Medical Council of
India and other stakeholders, however,
limits the marketing spend for drug promotion drastically. For example, the value
of gifts and other incentives extended to
medical professionals and chemists is restricted to 1,000 rupees (around $15). This
permissible value for a giveaway is enough
to ensure the brand recall, which is often
cited by firms as a reason for distributing
gifts, according to ministry officials.
Also, with respect to “physician’s sample”
as per the new rules, companies can offer a
doctor only the medicine required for full
treatment courses for three patients for free.
Companies are allowed to conduct
awareness campaigns and disease screen-
ing camps at public health centers but the
rules forbid stealth promotion of products.
Likewise, drug companies are barred from
making any claims on the efficacy of the
product without solid scientific evidence.
Violators will face harsh penalties as
the government mandates the rules to be
followed in“letter and spirit”once it comes
Penal provisions of the current draft are
ranging from a warning to suspension on
the sale of the company’s products for up to
a year or confiscation of all packs, depending
upon the severity of the breach. Drug makers
may also have to deal with a provision that
would see them face a marketing ban on top
of having to pay hefty penalties if the don’t
comply with the new rules.
The new rules also propose the position
of an Ethics Compliance Officer to keep
track of violations and ensure compliance.
The code will cover the entire supply
chain of pharmaceuticals and medical devices including retailers, distributors, wholesalers and doctors across the country.
Industry groups welcome the move
viewing the mandatory rules, when implemented, as a way to reign in controversial
practices employed by certain companies
to promote sales. Early enforcement of the
code with better transparency can remove
the ongoing uncertainty. At the same time,
they argue that the rules should not interfere with the doctors’ need to learn about
new medical advances in the field through
continuing medical education.
Meanwhile, certain firms have already
initiated their own marketing codes to allay
public mistrust. GSK Pharmaceuticals India,
which started new healthcare marketing
code to cover its field staff and doctors last
year, is an example. The company stopped
target-linked incentives for its 3,000-strong
sales force as part of its Patient Focused Selling program. GSK also decided to withdraw
direct payments made to doctors for speaking engagements. CP
Marketing Code Round The Corner
Proposal to limit giveaways; offenders face product ban