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.
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.
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 organizes ‘continuous medical education’ programs 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 organize screening camps or awareness campaigns at public health centers, 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 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