SOON, Upto Rs 1 crore penalty for unsafe medical device, Niti Ayog drafts bill
New Delhi: In a bid to bring all medical devices under one regulatory framework, the Government’s Think Tank – Niti Ayog has proposed a draft bill, Medical Devices (Safety, Effectiveness and Innovation) Bill, 2019 that prompts stringent provision of Rs 1 crore fine to be paid by medical device makers in case of any violation of safety, conditions of compliance and failure to protect personal health information of patients.
As per a recent media account, defaulters will not just have to bear monetary punishment rather they may also have to serve a period of imprisonment. For instance, in case of offences related to the sale of Medical Devices, a fine of up to Rs 50 lakh or jail for two years or both will be imposed while for Clinical Trial related offences may attract a fine of Rs 25 lakh or jail for two years or both. Fraud cases will be subject to punishment with a penalty of Rs 50 lakh or jail for 3 years or both.
The key provisions of the draft mentioned the preparation of a National Register of Medical Devices(NRMD).
Registration and Compliance
- All medical devices to be registered within a year of the Act coming into force.
- All registered Medical Devices will have a unique identification number (UID) on the label of the product.
- Medical device makers will have to comply with conformity evaluation requirements specified by the regulators, which will be done on the basis of the standard framed by the Bureau of Indian Standards.
- Manufacturers will have to submit clinical trial data to seek approval for the products.
- Post-marketing surveillance should be conducted by medical device manufacturers and adverse events related to the devices should be submitted.
Regulation of Medical Devices
The draft further proposes to constitute a separate regulator or Medical Device Administration, consisting of a chairperson with 11 other members will be appointed to regulate the medical device sector. The body will have the authority to conduct audits, give approvals as well as search and seizure.
The regulator will also be empowered to deny approval to those devices which have been recalled or declared unsafe or caused any adverse event in any other country. As per the proposed provisions, all medical devices will have to be registered in the NRMD before they enter the market. A provision for compensation for harm or injury is also added in the draft.
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“Undoubtedly a new regulatory agency with specialised expertise in medical devices would be a welcome move. The Central Drugs and Standard Control Organisation(CDSCO) lacks the requisite technical competence and has not been up to the mark in regulating the limited devices currently notified as drugs,” Malini Aisola of All India Drug Action Network told TOI.