Keeping the interest of the domestic manufacturers in mind, the Association of Indian Medical Device Industry (AIMED) has urged the Centre to change the definition of manufacturers in the draft amendment of Drugs & Cosmetics (Amendment) Bill 2015. The association stressed that only then will there be a genuine way to distinguish between genuine manufacturers and pseudo manufacturers.

It stressed that if Make in India vision is to succeed, government should not legitimise pseudo manufacturers by permitting importers and traders to label themselves as manufacturers.

Rajiv Nath, forum coordinator of AIMED, informed that the proposed definition of manufacturer in draft Bill 2015 is grossly misleading and incorrect and will enable made in China product to be labelled as made in India products.  As this definition allows unscrupulous importers to claim themselves to be manufacturers by changing the labeling and packaging requirements.

“If proposed definition is allowed to be carried through, it will simply defeat the very purpose of make in India vision as we will have an ironical situation where we will see products made in India but without these being actually manufactured in India. In other words India will be flooded with pseudo made in India products,” warned Nath who is also the joint managing director of Hindustan Syringes and Medical Devices (HMD).

Nath further informed that India’s imports last year crossed Rs.21000 crore, most of which were through unregulated route.

AIMED has already made these revelations known to the Centre along with their demand to have a separate rules and regulations for the sector with separate regulatory department for medical devices, different from pharma. They pointed out that this is essential if India wishes to end its import dependency on medical devices and encourage investments as the earlier attempt to regulate a few medical devices incompletely and incorrectly like pharma has been scaring away and confusing investors.

Giving some reprieve to the industry is the Centre’s recent decision to select medical devices as one of the five focus sectors under the make in India initiative. For which they had set up a task force under the chairmanship of secretary department of pharmaceuticals to boost domestic manufacturing. It is understood that the task force is soon expected to submit its observation to the relevant authority.