Even as the Department of Pharmaceuticals (DoP) has been seeking compliance reports from industry regarding implementation of the Uniform Code of Pharmaceutical Marketing Practices (UCPMP).
The Union ministry of chemicals and fertilizers is likely to soon share draft on Uniform Code for Medical Devices Marketing Practices (UCMDMP) with stakeholders for their suggestions towards a uniform code on medical device marketing practices in the country.
Like UCPMP, UCMDMP would be a self-regulatory framework for the industry and voluntarily in nature that aims to curb practices such as offering gifts to healthcare professionals to push a certain product.
Similarly, government has been mulling over to issue UCMDMP which will stipulate and prescribe limit to the incentives which can be provided to the doctors for recommending or using the medical device for the sake of patient safety and healthy competition.
As per the draft, UCMDMP, a medical device must not be promoted prior to receipt of the product registration (wherever applicable) by the competent authority, authorizing its sale or supply as per Medical Device Rules (MDR-2017).
The promotion of a medical device must be consistent with the terms of documents submitted by the companies for obtaining product registration or licenses to manufacture, import and sell these medical devices in India; and specifically the Instructions For Use (IFU) or Directions For Use (DFU) of the relevant product.
Product Information about Medical Devices must be up-to-date, verifiable and accurately reflect current knowledge or responsible opinion. Product Information about medical devices must be accurate, balanced, fair, objective, and must not mislead either directly or by implication. Product information about medical devices must be capable of substantiation.
UCMDMP draft stipulates that there are certain limits which need to be prescribed on a voluntary basis to start with so that such inductive mechanisms to distort markets are eliminated or removed.
UCMDMP has been drafted to ensure high ethical standards for the medical device industry much in the similar manner as has been done in the case of pharmaceutical industry by introducing Uniform Code for Pharma Marketing Practices (UCPMP) in 2011.
As per the UCPMP, no gifts, pecuniary advantages or benefits in kind may be supplied, offered or promised to persons qualified to prescribe or supply drugs, by a pharmaceutical company or any of its agents i.e. distributors, wholesalers, retailers, etc.
Gifts for the personal benefit of healthcare professionals and family members (both immediate and extended) (such as tickets to entertainment events) also are not to be offered or provided.
According to a senior health ministry official which drafted the UCMDMP, all such technologies which are closed systems like the Glucometer for which you have to buy the reagents of a particular brand can be given or considered as induced in turn incentive to the physician.
If a company gifts the doctor a Glucometer, he will be forced to buy and then recommend the strips of the same Glucometer although the Glucometer was free. So in a way you are distorting the market.”
The Medical Council of India (MCI) also prescribes the maximum number of incentives for a doctor. There are limits set in regulation which prohibit the manufacturer or trader to induce demand through incentivising the doctor but in case of medical devices the situation is very complex considering the cases mentioned above.
The UCPMP, a voluntary code was issued by the DoP in 2011 and its amended version came out in 2015. The marketing code lacks penal provisions to deter wrongdoers.
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