OBJECTIVES

: Continuous subcutaneous insulin infusion, also popularly called as Insulin pump therapy is an alternate and superior method of delivering insulin to the individuals with diabetes, which is more similar to psychological insulin delivery. The aim of the study is to apprehend the Regulations of Insulin Pumps in the three countries: USA, EU and India and compare the requirements for Marketing Authorization in these said regions.

METHODS

: Data was collected from Regulatory websites such as USFDA, CDSCO and EMA, review articles based on Insulin pumps, regulation of medical devices for the three regions. All the collected data was then studied and then comparison was done for different provisions for marketing authorization of Insulin pumps and its regulation in the USA, EU and India.

RESULTS

: In US, 40% of T1DM patients use Insulin pumps. In EU, overall insulin pump users with T1DM is 15%. Whereas in India, only 5% of the T1DM patients use Insulin pumps. Affordability plays the major role in limiting the use of CSII in India. The cost of insulin pump ranges from INR 1.5 lakhs to 4.5 lakhs and monthly cost of accessories is approx. INR 6000. In USA, private insurance companies provides full insurance on insulin pumps to patients, reimbursement/ insurance coverage is not available in India which leads to usage of pumps by those who can afford it. Other limiting factors to insulin pumps use are lack of knowledge of device, self-management, motivation etc.

CONCLUSIONS

: This study drafts the regulations of Insulin pumps in the three region, the USA, EU and India and provides the comparison of various provisions for its marketing authorization. The regulatory system of India is comparatively under developed as compared to the US and EU. The Medical Device Rules, 2017 introduced by the Indian government is a step forward towards better regulation of medical devices.