Govt approves programme to safety of medical devices

The government has approved "materio vigilance" programme to assess safety of medical devices, the Rajya Sabha was informed today.
Health Minister J P Nadda said as part of the programme, adverse events associated with medical devices will be reported online to the nodal collaborating centre.
"Yes. As part of the programme, adverse events associated with medical devices will be reported online to the nodal collaborating centre.
"Such events will thereafter be analysed by the technical committee and based on the findings of the committee, further action as considered appropriate will be taken," Nadda said while replying to a written question.

He said that data generated through the materio vigilance will be one of the inputs for assessing the benefit-risk profile of medical devices across the country.
The Health Minister said that inputs other than those received from the programme will also be used to ensure the authenticity of such devices.

Replying to another question, he said that his ministry has constituted a high-level committee to assess the health and environmental impact of use of Polyethylene Terephthalate (PET) bottles used as primary packaging material in pharmaceutical liquid orals, suspensions and dry syrups.
He said, in May and August 2013, a Dehradun-based NGO requested to impose a ban on such bottles, claiming that it had adverse effects on human health due to the presence of endocrine disruptors and leaching which takes place under varying storage and temperature conditions.

The representation was considered by the Drugs Technical Advisory Board and an expert committee under the head of Pharmacology department of AIIMS was constituted which amongst others had suggested that a scientific evidence needs to be generated over a period of time.
He said that a draft notification prohibiting the use of PET containers in liquid oral formulations for primary packaging of paediatric formulations was published in Gazette in September 2014 inviting objections and suggestions from the public. In response 292 representations opposing the ban has been received.