The government has suggested five years for shelf life of all medical devices in the draft released on 19th October. These regulations have been disliked on many grounds because of shelf life of medical devices suggested in the draft.
A senior government official said if the government could reconsider this proposal that they might consider temporary audit and evaluation of the equipment to decide whether an extension on the shelf life can be given. The decision on extending the shelf life will be done on a case to case basis.
In Indian conditions, the shelf life of medical devices is only up to five years so this period is suggested in the draft, a senior government official explained. The industry argues, orthopaedic implants are an example having more than 5years shelf life medical device.
The recent letter to the Secretary of the Department (Pharmaceuticals) as reviewed and stated, “CDSCO Inspectors will take years to develop the needful ability 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 develop 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 build different medical devices regulations as it was widely felt that devices should be treated differently from drugs.
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