Govt going through suggestions received for medtech regulations

Based on the inputs received from various stakeholders, the union health ministry is expected to modify the preliminary draft of medical technology guidelines that it had released earlier

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New Delhi: The draft Medical Devices Rules have been e-gazetted on October 17, 2016 for inviting comments and suggestion from all stakeholders. Till now, comments and suggestion have been received from some organization. The last date for receipt of comments was November 16, 2016. The Minister of State (Health and Family Welfare), Mr Faggan Singh Kulaste stated this in a written reply in the Parliament recently.

The minister mentioned that availability of a transparent, objective and predictable regulatory framework for medical devices is a pre-requisite for boosting domestic manufacture of medical devices. Draft Medical Devices Rules have been framed keeping this in view. Further, the Government is providing some facilities for medical devices parks such as Andhra Pradesh Med Tech Zone (AMTZ) to set up common facilities.

“Draft Medical Devices Rules have been framed keeping this in view. Further, the Government is providing some facilities for medical devices parks such as Andhra Pradesh Med Tech Zone (AMTZ) to set up common facilities,” Mr Kulaste added.

Currently the government is looking at providing distinct identity to the medical technology industry though it is more keen on the manufacturing in India to reduce cost. However, government is also apparently aiming to strike balance between foreign and domestic players while framing new rules. Untill now, the majority of medical technologies in India are imported from abroad. The government wants the change in this status quo but it has to take the views of foreign MNCs into consideration as well.

The final draft of the new rules post consultations is expected to be released in December.