To ensure a level playing ground for domestic manufactures, the medical devices industry wants the Centre to adopt Japanese model of market access authorization holder (MAAH) in its proposed regulatory framework for the industry while regulating marketing companies.
Devices industry feels that this move is essential to protect the interest of the domestic players who have to undergo a sling of regulatory framework before getting the approval compared to traders who just market the finished products without any hassles.
The concept of MAAH is followed by the regulatory system in Japan where marketing companies are authorized to sell the medical devices in the market and that this product can be made by it or some other company on its behalf. However, under this system, the legal manufacturer will be responsible for compliance of QMS and other regulatory measures as required by the regulatory authority of Japan.
“Regulations are used by most countries to ensure patient safety and safeguard domestic industry by using it as a non tariff barrier. If done wisely we can encourage domestic and overseas investment to enable make in India and reverse our excessive 70 per cent import dependency. We hope that the government would endorse our stand as this is strategically very important for ensuring make in India and creating identity for Indian manufacturers,” stressed Rajiv Nath forum coordinator of AIMED.
AIMED also impressed upon the urgent need to go away with the European concept of the definition of legal manufacturers, as it allows a trading or marketing company to be called a manufacturer. AIMED informed that the definition of manufacturer is incorrectly proposed in draft medical device rule, by CDSCO.
The association argued that the definition of ‘manufacturer’ as proposed by CDSCO, seemingly at behest of US MNC lobby in draft rules is in conflict with labelling defined in Weights and Measures Act. They stated that it is also against ‘make in India’ as it legalizes pseudo manufacturer and incorrectly allow traders or marketing company to be called and labelled as manufacturer.
“This is unfair for actual manufacturers who have toiled and invested in green field projects. It is important to note that incorrect definition of legal manufacturer coined in Europe has hurt the European domestic industry as complete products have been farmed out to manufacturers in China, India, Malaysia etc. and are claimed to be made by European company. Our proposal is aimed to enable regulation to be used strategically for driving ‘make in India’ as is done by Japan for boosting and protecting their domestic manufacturers. While the labelling proposed by us is in line also with existing Weights and Measures Act,” he added.
This demand comes in the wake of recently concluded meeting on the proposed regulatory framework that indicated IMDRA to regulate the manufacturer and the importer, while delegating the regulation of trading companies to the state licensing authority.
AIMED pointed out that for better transparency it has recommended IMDRA to regulate the market access authorization holder as well, whether the MAAH is the manufacturer or a marketing company or an authorised agent of the overseas manufacturers. While it is open for the SLAs to regulate the domestic reseller – wholesaler or retailer or healthcare provider.
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