As India gets ready to enforce its new medical device regulations in January, the government is gearing up to release a new uniform code for medical device marketing practices.
Previously, India’s devices were regulated as pharmaceuticals, and the new regulations separate out devices for the first time from broader drug regulations.
Regulation of marketing practices for devices currently falls under the broader Uniform Code for Pharma Marketing Practices (UCPMP), which was introduced in 2011 and amended in 2015.
Under the UCPMP, drug and device companies cannot offer gifts or benefits to medical practitioners that would provide incentives to prescribe their products. The code, however, is voluntary and lacks any penal provisions to deter unethical practices.