Medical devices preferential market access policy highly disappointing: AIMED

Nath also informed that several suggestions made by AIMED to encourage and boost manufacturers producing in India over imports have not been considered

Rajiv Nath, Forum Coordinator, Association of Indian Medical Device (AIMED) industry has expressed deep disappointment over the Draft Medical Devices Preferential Market Access (PMA) Policy issued by DoP.

“We are disappointed with the Draft of PMA policy issued by DoP. We will study it collectively and respond shortly but it is a clear case of a lost opportunity to promote indigenous manufacturing of medical devices to boost ‘Make in India’ initiative,” Nath said.
He also said that 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 third country Regulatory approval mandatory clauses e.g. US FDA.

It doesn’t provide for any Corpus for ensuring no late payments by Government. Such a corpus would be necessary to ward of any adverse impact on financials of a company in case of delayed payments by the Government.
Nath also informed that they are yet to study the Draft PMA in detail and take a stand but regret to note that following suggestions made by them to give encouragement and boost manufacturers producing in India over imports have not been considered e.g.

• Preferential pricing for domestic manufacturers based on World Bank norms.
• Preference for ICMED/ISO certified manufacturers to boost quality.
• Preference for Design India Certified Manufacturers to boost indigenous development
• Timely payment against govenment supplies
• Penal provision against hospitals that keep exclusionary compliance Clause of USFDA certification as third country regulatory approval.

By denying preferential pricing to Indian manufacturers, the draft policy guidelines can be said to be bordering on encouraging ‘pseudo manufacturing’, he felt. It is sad that genuine concerns and suggestions of domestic medical device manufacturers are being repeatedly sidelined.