Code for medical devices welcomed

The Department of Pharmaceutical (DoP) had recently published the draft Uniform Code for Medical Device Marketing Practices (UCM DMP). It is aimed at bringing in a voluntary code to regulate fair marketing practices by the medical device industry.

Background

• The medical devices sector in India is an essential and integral constituent of the Indian healthcare sector, particularly for the prevention, diagnosis, treatment and management of medical conditions, diseases, illnesses, and disabilities.
• The current market size of the medical devices sector in India is estimated to be $11 bn and its share in the global medical device market is estimated to be 1.5%.

Sector Wise Classification of medical devices

• Electronics Equipment
• Implants
• Consumables and Disposables
• IVD reagents
• Surgical Instruments

Need for a Uniform Code for Medical Device Marketing Practices:

• In India, Rules on National Medical Devices are formulated by the Department of Pharmaceuticals, Ministry of Chemicals & Fertilizers.
• At present, medical devices companies may voluntarily adopt and follow the Uniform Code for Pharmaceutical Marketing Practices ("UCPMP"), which is primarily applicable to the pharmaceutical industry.
• The Department of Pharmaceuticals, acknowledging that the medical devices industry is a separate constituent of the healthcare system, sought to frame a Uniform Code for Medical Device Marketing Practices (UCMDMP).
• The Department of Pharmaceutical (DoP) had recently published the draft Uniform Code for Medical Device Marketing Practices (UCMDMP).
• It is proposed to be a voluntary code that companies may elect to adopt, though the government has specified that they may make it a statutory code if it is not effectively implemented.

Salient Features of Uniform Code for Medical Device Marketing Practices (UCMDMP)

Health Care Professional (HCP)

• Any person or entity that is authorised to provide healthcare services or items to patients, or is involved in the decision to purchase, prescribe, order, use or recommend a medical device in India.

Comparative Advertisements

• Prior consent from a competitor need not be obtained for using their brand name as long as the feature of the competitor's product that is the subject of comparison is clearly specified within the advertisement.

Role of Medical Device Representatives

• The UCMDMP envisages a more involved role for medical device representatives in a clinical setting than medical representatives under the UCPMP.
• The representatives are expected to provide technical support to HCPs on the safe and effective use of the devices.

Training of HCPs by Medical Devices Companies

• Companies are expected to develop training sessions on the effective use of devices and their use in procedures, which will be a requirement for an HCP to get access to the product.

No Gifts

• No gifts, pecuniary advantages or benefits in kind shall be supplied, offered or promised to persons qualified to use, prescribe or supply Medical Devices, by a Medical Device Company or any of its agents i.e., distributors, wholesalers, retailers etc.
• The UCMDMP has done away with the restriction on the use of the word "new" for products that have been in the market for over a year, which is present under the UCPMP. Medical devices must not be promoted prior to obtaining the requisite registrations and licenses for sale under the Medical Device Rules, 2017.

Significance

• A uniform code will translate into more credible healthcare delivery as well as restrain the fly by night operators– who pose a great risk for patients and the reputation of the medical device industry.
• Medical devices are characteristically different from pharmaceuticals and therefore a separate code for medical devices was much needed to accurately capture the ethical marketing practice requirements for the medical device sector.
• The implementation of UCMDMP will be a big step towards furthering patient interest and “will restrain the unethical element and restore competitiveness and esteem for the compliant players.”

Exam Track

Prelims Take Away

• UCMDMP