MUMBAI (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.
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.
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.
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 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