The medical device industry expressed shock and concern over the recent notification issued by the health ministry, stating that it hardly addresses any major issues of the industry and rather only adds up to their present woes by complicating the matters further. There is a strong discontent among many against this move as they feel that it had been taken without considering the best interest of industry even after airing the difficulties faced by the industry in respect of growing import and trade dependency of medical devices.

Through a notification on 25th September, 2014, the health ministry amended the Rule 109A of the Drugs and Cosmetics Rules (D&C Rules) to make labelling of medical devices mandatory in the country. However, it states that all the requisite details shall be printed on the label or sticker on the shelf pack or on every outer covering in which the medical device is packed. It clearly makes no mention of labellings units packs.

Industry countered that the decision to make labelling mandatory for shelf pack alone of the medical device will hardly have any regulatory implication, as importers will still be able to have a free reign over pricing on unit packs. Since law still does not make it mandatory for manufacturers to put labelling on unit packs, importers will be able to charge as per their discretion, pointed out Association of Indian Medical Device Industry (AIMED).

The association further claimed that in many instances importers import the goods falsely claiming them to be for institutional sales and not for sales over the retail counter. Rajiv Nath, forum coordinator of AIMED stressed all these activity is not only affecting the domestic manufacturers but also generating artificial inflation in the market affecting the end users directly.

He observed that the only way to understand this issue and counter the malpractices were by having deliberations with the industry. Nath insisted that the Centre should have taken cognizance of the suggestions that the industry had given to the government before notifying the Rule to make it productive, as their act of completely overlooking their suggestions is going to have a counterproductive result on the industry.

“Ever since the government had released the draft notification last October, we have been briefing them about the urgent changes need to be made in the same, as the draft in its present form never never served our purpose. However, even after our repeated attempts to convince the government on the pitfalls in the draft the government went ahead with this notification. This notification fails to make any difference for the sector, except negatively, as the decision has been taken without taking into consideration the suggestions given by industry at large,” informed Nath.