Why mandatory USFDA nod for medical devices, Questions Parliamentary Panel

The Committee observed that since basic equipment like a multiparameter monitor, defibrillator, transport monitor among many others are easily available with Indian manufacturers, therefore, do not essentially need USFDA certification.

New Delhi: The Parliamentary Standing Committee on health in response to a query regarding details of equipment procured under the classification of mandatory U S Food and Drug Administration (USFDA) has strongly criticized the practice of insisting on USFDA (Food and Drug Administration) approval for medical devices procured by the government. The panel in its report stated that there was hardly any country besides the US which made such approval mandatory.

The committee’s observations were made in the context of procurement of devices under the Pradhan Mantri Swasthya Suraksha Yojana (PMSSY).

The Committee has noted that out of total 442 equipments procured, USFDA certification was mandatory for only 23 equipments. The Committee fails to comprehend the reasons for procuring only these 23 equipments with mandatory USFDA certification.

As per the Committee understandings, the USFDA is a regulatory mechanism for protecting and promoting public health and control and supervision of food and drugs including medical devices with specific reference to the United States but there is hardly any country in the world besides the United States which makes a provision for allowing USFDA as a mandatory condition.

The Committee observed that since basic equipments like multiparameter monitor, defibrillator, transport monitor among many others are easily available with Indian manufacturers, therefore, do not essentially need USFDA certification.

The Committee also has welcomed and taken into consideration the recent circular of the Department of Health & Family Welfare dated 20th February, 2018 on the guidelines regarding requirement / non-requirement of USFDA/CE certification etc. in procurement of medical devices wherein para 2(ii) it has been stated that for 'quality reasons' doctors would be free to insist on USFDA certification.

The Committee was distressed to note that simple devices like multiparameter monitor are being procured with USFDA mandatory certification. The Committee has observed that the mentioned 68 circular was just another attempt to camouflage the USFDA requirement in the name of quality and this is going to be a big drain and set back to Indian manufacturers.

The Committee has strongly recommended that the Department should fix certification requirement as USFDA or CE or BIS or any other internationally accepted certification in the interim till BIS standards are established universally so as to leave no option for discretion and its misuse.

The Committee has also recommended that the matter may also be taken up on a priority basis, with the Bureau of Indian Standards (BIS) so that every single equipment procured in India has a BIS standard which would be equivalent to international quality certification.

The Committee has emphasized that the medical device industry of India is a huge market with enormous manufacturing potential and recommended that the Department must make a concerted effort in promoting ‘Make in India’ program in the medical device industry, in coordination with the other government departments.

The Committee has also strongly recommended that the Department should take up the matter with BIS so that guidelines/standards for all medical devices are developed and established in time with the international standards and practices relating to procurement of medical devices.