The medical devices industry has approached the Central government to create a Medical Devices Advisory Board to have a proper policy and regulations to govern this sector. Currently this industry is not coming under the regulatory umbrella of ant particular ministry or department of the Centre.
Joining the chorus of different bodies in the industry who have already aired similar complaints and demands, the All India Syringes and Needles Manufacturers Association has urged the Government to set up the Board to give a concrete direction to the growing industry.
Noting that the interpretation and implementation of the existing laws are varied from state to state, the association has called for periodical training and competency assessment exercise for the inspectors of the state drug authorities to bring in uniformity at the national level.
``The medical devices are totally different from pharma products, in the terms that the pharma products of the same terminology may have different doses with different formulae. But the medical devices under a product family are of similar in nature, except for the size, gauge and length combinations. As per the existing guidelines, the product family of medical devices should be treated as one product rather than considered as different products and for each size. But some state authorities were having different interpretations and treat products of the same family as different individual products,'' a representation by the association said.
They also objected to the existing practice of getting separate permissions from the authorities for manufacturing one item in more than one brand. Association general secretary N K Jain told Pharmabiz that at present they were left at a loss with no clarity in policies. ``Different ministries like health, science and technology and commerce are involved in the area of medical devices, making things so complicated. The government should better bring this sector under one administrative ministry to have clarity and transparency,'' he said.