By Zeba Siddiqui
MUMBAI, Aug 2 (Reuters) - India, one of the world's largest
markets for pharmaceuticals, is drawing up its first set of
marketing rules for drugmakers, restricting gifts and trips
offered to doctors and pharmacists to 1,000 rupees ($15),
according to a draft proposal seen by Reuters.
While such rules are common elsewhere in the world and
adhered to by large pharmaceutical companies, they are not set
in stone in India, where campaigners have long demanded a
crackdown on unethical selling practices. These have included
gifts ranging from electrical appliances to foreign junkets to
encourage doctors and pharmacists to prescribe and stock certain
medications.
Currently, India has only a voluntary marketing code that
critics say is ineffective.
"In India, corruption and bribery of doctors is widespread,"
said Samiran Nundy, one of India's leading gastrointestinal
surgeons. "I've seen a range of ways in which this works, from
presents to doctors to paying for them to attend conferences in
places like Thailand."
"It's great that marketing rules are coming into place, but
there are a huge number of regulations in India that are not
enforced," he added. "I hope that these will be enforced."
Apart from limiting marketing spending, the draft proposal
drawn up the Department of Pharmaceuticals and being reviewed by
India's law ministry would also forbid drugmakers from making
misleading claims around the curative abilities and efficacy of
drugs.
The rules also impose strict limitations on the number of
trial samples offered to doctors.
An official at the Department of Pharmaceuticals declined to
comment on the specifics of the draft, but told Reuters that the
order was being reviewed.
The official, who asked not to be named, said no timeline
has yet been set on the implementation of the new rules.
According to the draft seen by Reuters, a failure to abide
by the rules will result in a marketing ban on a drugmaker for
more than a year depending on the degree of the violation, and
the confiscation of "all packets of the highest selling brand of
drugs" made by that company.
The seized drugs will be handed over for use at government
hospitals across the country.
Companies can turn a marketing suspension order into a cash
fine, according to the proposal. They will have to pay penalties
of between 500,000 rupees ($7,800) and 100,000,000 rupees ($1.56
million) to reverse a marketing suspension order, depending on
the severity.
MANDATORY CODE
In a letter last year, Tapan Sen, a member of India's upper
house of Parliament, urged the government to act on drafting a
mandatory code on the marketing of pharmaceuticals, citing
irregular practices by several companies.
Indian media reported that the letter said the country's
largest drugmaker, Sun Pharma, Abbott India and privately-held
Macleods Pharmaceuticals were among drugmakers found to have
sent doctors on "pleasure trips."
Abbott said at the time that it had a strict policy against
providing gifts and other incentives to doctors, while Macleods
refuted the allegations.
A Sun spokesman told Reuters the company organises
'continuous medical education' programmes to educate doctors,
not promote its products, and these are compliant with the
voluntary marketing guidelines set by the government in 2015.
The current draft says companies will be allowed to organise
screening camps or awareness campaigns at public health centres,
but it bars advertising by stealth and mandates that doctors
involved in such events be paid commensurate to their average
daily income.
To ensure implementation of the rules, an 'Ethics Compliance
Officer' of the rank of joint secretary to the Indian government
would be appointed.
Pharmaceutical marketing practices have long been a subject
of controversy globally. In India, where health insurance is
scarce and many rely on pharmacists for medical advice, critics
say sketchy practices have led to the over-prescription of
strong cocktail drugs, causing drug-resistance.
GlaxoSmithKline GSK.L was battered by a bribery scandal in
China that landed it with a record $490 million fine in 2014.
It went on to slash the number of sales reps and overhaul
its business globally, stopping sales-based incentives for drug
reps and reducing paid junkets for doctors.
(Editing by Clara Ferreira Marques, Euan Rocha and Raju
Gopalakrishnan)
Keywords: INDIA PHARMACEUTICALS/