The Patient Safety and Access Initiative of India Foundation (PSAIIF) has filed a Public Interest Litigation (PIL) in the Delhi High Court to address the growing concern of illegal imports of refurbished medical devices into India. This trend poses significant risks to patient safety and undermines the country's healthcare system.
Key Concerns:
- Illegal Imports: Refurbished medical devices, such as CT scanners, MRI machines, and surgical robotics, are being imported without necessary approvals, violating India's regulatory framework.
- Patient Safety Risks: These devices may not meet safety standards, putting patients at risk.
- Undermining Self-Reliance: Imports compromise India's "Make in India" initiative and domestic manufacturers' confidence.
Petition Details:
The PIL seeks directions from respondents, including the Central Board of Indirect Taxes and Customs, DGHS, MoEFCC, DGFT, and Intuitive Surgical India Pvt Ltd, to:
- Identify and furnish a list of imported refurbished medical equipment since 2019.
- Recall installed devices without prior approval.
- Stop importing refurbished devices until a policy framework regulates their import.
Violations and Non-Compliances:
The petition highlights that Intuitive India Private Limited imported refurbished equipment worth over INR 250 crores without required MoEFCC approval. Despite DGHS's notification allowing select devices under strict conditions, MoEFCC's approval remained mandatory.
Responses and Reactions:
The Delhi High Court directed PSAIIF to submit representations to the concerned respondents. Recently, PSAIIF received responses from MoEFCC and DGHS. However, MoEFCC granted further approvals in 2024, conflicting with DGHS's stance on prioritizing domestic manufacturing.
PSAIIF urges immediate action to enforce compliance, increase public awareness, and ensure only safe, certified medical devices are available in the Indian market.
This PIL aims to safeguard patient safety and promote a reliable healthcare system in India. By addressing the illegal import of refurbished medical devices, PSAIIF seeks to protect the integrity of India's healthcare system and support domestic manufacturers.
(Input from various sources)
(Rehash/Vaishnavi Dalvi/MSM)