The Association of Indian Medical Device industry has expressed disappointment over the Draft Medical Devices Preferential Market Access (PMA) Policy which has been issued by Department of Pharmaceuticals (DoP).
“We are disappointed with the Draft of PMA policy. It is a clear case of a lost opportunity to promote indigenous manufacturing of medical devices to boost ‘Make in India’ initiative,” RajivNath, forum coordinator, Association of Indian Medical Device industry (AIMED) said in a statement.
“The Draft PMA policy in its present form does not provide preferential pricing to Indian manufacturers, no incentives on maintaining and improving quality, indigenous development and no redressal / penal provisions against use of exclusionary 3rdcountry regulatory approval mandatory clauses e.g. US FDA,” he said.
He added, “It doesn’t provide for any corpus for ensuring no late payments by Government. Such a corpus would be necessary to ward off any adverse impact on financials of a company in case of delayed payments by the Government.”
Stating that the association will soon take a firm stand, he said suggestions made by them to encourage local producers over imports had not been considered.
