US cracks down on doctor-drugmaker dealings. Time for India to follow suit?
Docs prescribing by brand instead of composition is hurting Indian consumers
Drugmakers in the US will now have to make public any payment above $10 made to doctors, or invite heavy penalties. New federal guidelines make it mandatory for companies to disclose payments towards research, consulting, travel or entertainment.
Under the rules, drafted by the department of pharmaceuticals (DoP), federal officials will inspect and audit company records to authenticate the data provided.
Those found to be in violation of the order will be asked to pay up to $10,000 for every payment they fail to report. However, where a firm is found to have deliberately failed to report a payment, the penalty could be as high as $100,000 per violation.
The new set of rules is targeted specifically at sponsorships by drugmakers, including gifting, but could become a statutory code if the DoP believes the execution on the part of companies isn’t up to the mark.
This is quite a contrast with India, where the code of marketing practices for drugmakers is voluntary in nature and without any stringent provision. The common practice here is of medicine companies sponsoring not just research and continuing education of doctors, but also shelling out gifts in cash and kind, apart from sponsoring their trips.
The $12 billion pharma market in India is largely a branded generics market. However, with doctors prescribing medicines by brand name rather than the composition, it leaves room for prescribing costlier brands of the same medicine belonging to companies that have rendered support, say experts.
“The freebie to a doctor hurts consumers as it often leads to prescription of a medication or device not really required or prescription of those that cost more. As this is the only sector where the decision to buy is made by doctors, there needs to be regulation that can restrict such malpractices,” said Bejon Misra, founder of Partnership for Safe Medicines-India.
With nearly 7 lakh practising doctors and more than 200 large and mid-sized drug and medical device makers, it's high time India put effective guidelines in place to redefine the doctor-drugmaker ties.
Currently, there are dos and don'ts for doctors on accepting gifts and travel drafted by the Medical Council of India, but there is no corresponding regulation for drugmakers which dole out the gifts, said CM Gulhati, editor of MIMS India, a reference journal for medical practitioners. "Having voluntary guidelines is as good as not having any as they don't come with penalties attached. Also, it should ideally be the health ministry and not the DoP which should bring in regulations, as the DoP's job is to promote the pharma industry," said Gulhati.
Gurmit Singh Chugh, MD, Translumina Therapeutics, a medical devices firm, called for guidelines mandating declaration of investments made by drugmakers on doctors and penalising those not adhering to these, in line with the development in the US.
Docs prescribing by brand instead of composition is hurting Indian consumers
Drugmakers in the US will now have to make public any payment above $10 made to doctors, or invite heavy penalties. New federal guidelines make it mandatory for companies to disclose payments towards research, consulting, travel or entertainment.
Under the rules, drafted by the department of pharmaceuticals (DoP), federal officials will inspect and audit company records to authenticate the data provided.
Those found to be in violation of the order will be asked to pay up to $10,000 for every payment they fail to report. However, where a firm is found to have deliberately failed to report a payment, the penalty could be as high as $100,000 per violation.
The new set of rules is targeted specifically at sponsorships by drugmakers, including gifting, but could become a statutory code if the DoP believes the execution on the part of companies isn’t up to the mark.
This is quite a contrast with India, where the code of marketing practices for drugmakers is voluntary in nature and without any stringent provision. The common practice here is of medicine companies sponsoring not just research and continuing education of doctors, but also shelling out gifts in cash and kind, apart from sponsoring their trips.
The $12 billion pharma market in India is largely a branded generics market. However, with doctors prescribing medicines by brand name rather than the composition, it leaves room for prescribing costlier brands of the same medicine belonging to companies that have rendered support, say experts.
“The freebie to a doctor hurts consumers as it often leads to prescription of a medication or device not really required or prescription of those that cost more. As this is the only sector where the decision to buy is made by doctors, there needs to be regulation that can restrict such malpractices,” said Bejon Misra, founder of Partnership for Safe Medicines-India.
With nearly 7 lakh practising doctors and more than 200 large and mid-sized drug and medical device makers, it's high time India put effective guidelines in place to redefine the doctor-drugmaker ties.
Currently, there are dos and don'ts for doctors on accepting gifts and travel drafted by the Medical Council of India, but there is no corresponding regulation for drugmakers which dole out the gifts, said CM Gulhati, editor of MIMS India, a reference journal for medical practitioners. "Having voluntary guidelines is as good as not having any as they don't come with penalties attached. Also, it should ideally be the health ministry and not the DoP which should bring in regulations, as the DoP's job is to promote the pharma industry," said Gulhati.
Gurmit Singh Chugh, MD, Translumina Therapeutics, a medical devices firm, called for guidelines mandating declaration of investments made by drugmakers on doctors and penalising those not adhering to these, in line with the development in the US.
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