The Indian Pharmacopoeia Commission's Role in Medical Device Standards

Indian Pharmacopoeia Commission (IPC): INDIA’S PUSH FOR standardised medical devices

1. What is the Indian Pharmacopoeia Commission (IPC)?

The IPC is an autonomous institution under the Ministry of Health and Family Welfare. Traditionally, it sets quality standards for medicines in India, but it is now expanding its mandate to cover medical devices as well. This initiative aligns India with international benchmarks such as those in the US, Japan, and the European Union.

2. What new responsibility has IPC undertaken?

For the first time, the IPC will establish standards for medical devices in collaboration with the Bureau of Indian Standards (BIS). Its role includes auditing manufacturers, developing monographs (reference documents specifying product standards), and ensuring that devices meet global safety and quality norms.

3. Why is this shift important?

India’s medical device market is valued at around $12 billion, yet 60–70% of devices are imported. By developing indigenous standards, India can reduce dependence on imports, strengthen domestic manufacturing, and make locally produced devices acceptable in global markets.

4. How will IPC and BIS collaborate?

The two agencies will jointly prepare guidelines and testing frameworks. While IPC will focus on defining scientific and clinical standards, BIS will oversee implementation through certification and product audits. This collaboration will harmonize India’s regulatory environment with global systems.

5. What are the expected outcomes?

The initiative aims to expand India’s medical device sector to $50 billion by 2030, enhancing exports and competitiveness. It also supports the Make in India and MedTech initiatives by ensuring devices meet stringent safety benchmarks and earn international trust.

SYNOPSIS (75 words)

The Indian Pharmacopoeia Commission (IPC) has broadened its mandate to create standards for medical devices, in partnership with the Bureau of Indian Standards. This marks India’s first unified effort to ensure device quality and global acceptance. With a $12-billion market and 70% import dependence, the initiative seeks to boost domestic production, harmonize regulations, and align India’s MedTech industry with international benchmarks by 2030.