Government to consider extending shelf life of medical device after interim assessment of performance

The recent draft of the medical devices regulation has drawn the industry's flak. These regulations have been disliked on many grounds. One of the reasons industry is unhappy with the government is the shelf life of medical devices as suggested in the draft. 

The government has suggested a five year blanket on shelf life of all medical devices in the draft released on 19th October. When asked if the government could reconsider this proposal, a senior government official told Business Standard that they might consider interim audit and assessment of the equipment to decide whether an extension on the shelf life can be given. This official told Business Standard that the decision on extension will be done on a case-to-case basis. 

 

He explained that in Indian conditions, the shelf life of medical devices is only up to 5 years, hence this period is suggested in the draft. The industry argues that orthopaedic implants are an example of medical device that have a shelf life more than five years. 

The Association of Indian Medical Devices Industry has written to the secretary of the Department of Pharmaceuticals asking the government to reconsider many proposals suggested in the draft notification. Also, Industry feels that through the regulations such as quality assessment by the CDSCO, the government is not making it easy for doing business. The industry wants third-party audits of medical devices.

The recent letter to the Secretary of the Department of Pharmaceuticals reviewed by Business Standard stated,"CDSCO Inspectors will take years to develop the needful competency to assess the diverse nature of manufacturing technologies that involves electronics, radiation, metallurgy, microbiology, chemistry, genetics, and nano Science etc. For the industry to thrive, there should be a change in mindset of quality control inspectors.  

The recent letter to the Secretary of the Department of Pharmaceuticals as reviewed by Business Standard stated, "CDSCO Inspectors will take years to develop the needful competency to assess the diverse nature of manufacturing technologies involved ranging from electronics to radiation to metallurgy to microbiology to implants, plastics, rubbers, steels, chemistry, genetics, nano science etc. and to evolve from an inspector quality control mindset to a risk mitigation quality management mindset needed for this innovative diverse engineering industry to thrive." The government decided to frame different regulations for medical devices as it was widely felt that devices should be treated differently from drugs.