No more freebies? India plans crackdown on marketing by drugmakers (updated)

Abbott India

02/08/2017 13:43

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. 
    Such rules are common overseas, but are not set in stone in 
India, where campaigners have long demanded a crackdown on 
unethical selling practices that include gifts ranging from 
electrical appliances to foreign trips to woo physicians and 
pharmacists into prescribing and stocking specific medicines. 
    The country has voluntary marketing guidelines for 
drugmakers, but critics say they are ineffective. 
    "In India, corruption and bribery of doctors is widespread," 
said Samiran Nundy, a leading gastrointestinal surgeon. "I've 
seen a range of ways in which this works, from presents to 
doctors to paying for them to attend conferences." 
    "It's great that marketing rules are coming into place," he 
added. "I hope that these will be enforced."      
    Besides limiting marketing spend, the draft proposal drawn 
up the Department of Pharmaceuticals (DoP) and under review of 
India's law ministry, also forbids drugmakers from making false 
claims on the curative abilities and efficacy of drugs. 
    An official at the DoP declined to comment on the draft's 
specifics, but confirmed to Reuters that the order was under 
review, though the implementation date for the rules is not set. 
    The draft says a failure to abide by the rules would result 
in a marketing ban on a drugmaker for up to a year, or more, 
depending on the degree of the violation. It would also lead to 
confiscation of all packs of the company's highest-selling drug 
brands, which would then be given away to government hospitals. 
    Companies would also be able to turn a marketing suspension 
order into a fine, according to the proposal, by paying 
penalties of between 500,000 rupees ($7,800) and 100 million 
rupees ($1.56 million), depending on the order's severity. 
     
    TRIAL SAMPLES 
    The rules limit the number of free samples a company can 
offer a doctor to full treatment courses for three patients. 
    But they don't specify that the only new medicine samples 
can be given away for free, noted Amitava Guha, national 
co-covener of the healthcare-focused civil society group Jan 
Swasthya Abhiyan.  
    "If this is applicable to all medicines of a company, there 
will be no change in the present situation," he said, calling it 
a major loophole that the companies could exploit. 
    He also said the marketing ban penalty was vague as it did 
not specify if it would bar the company from marketing all, or 
specific products. The penalty would be "meaningless" for a 
single product, as drug company salesmen market in private 
meetings so there is no material evidence, Guha said.  
    The Indian Pharmaceutical Association (IPA), a lobby group 
of India's largest drugmakers, said it supports mandatory rules 
for curbing undesirable marketing practices, but they should be 
transparent, easy to implement and unambiguous. 
    This "should not be reduced to yet another "Inspector Raj," 
IPA Secretary General D.G. Shah said, adding that rules should 
also address the need for doctors' continuing medical education. 
    "Someone has to take responsibility of keeping doctors up to 
date with the latest advances in the field of medicines." 
    The draft rules allow drugmakers to sponsor trips for 
doctors, pharmacists and relatives to attend seminars, medical 
conferences or scientific meetings, so long as the companies 
maintain a record of the minutes, expenses and agenda. 
     
    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  SUN.NS , Abbott India  ABT.N  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. 
    Sun told Reuters it 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 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 Euan Rocha, Raju Gopalakrishnan and David Evans) 
 ((zeba.siddiqui@tr.com; +91-9769624550; Reuters Messaging: 
zeba.siddiqui.thomsonreuters.com@reuters.net)) 
 
Keywords: INDIA PHARMACEUTICALS/