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MEDICAL DEVICES UNDER DRUGS LAW

The Topic covers GS paper 2[Government policies and interventions for development in various sectors and issues arising out of their design and implementation.]

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Context


  • To ensure that all medical devices meet certain standards of quality and efficacy, the Union Health Ministry notified medical equipment used on humans or animals as "drugs" under Section 3 of the Drugs and Cosmetics Act, with effect from April 1, 2020. 

  • The ministry, through a gazette notification, also released the Medical Devices Amendment Rules, 2020, for mandatory registration of medical devices. 


What is the Background?


  • The aim is to regulate all medical devices so that they meet certain standards of quality. 

  • Besides it will also make medical device companies accountable for quality and safety of their products. 

  • Once notified, the manufacture, import and sale of all medical devices will need to be certified by the Central Drugs Standard Control Organisation (CDSCO). 

  • At present, only 23 categories of medical devices are regulated under the law.


What is the status of medical devices sector in India?

 

  • Medical devices sector in India is very small in size as compared to the rest of the manufacturing industry, though India is one of the top twenty markets for medical devices in the world and is the 4th largest market in Asia after Japan, China, and South Korea.

  • India currently imports 80-90% of medical devices of the $15 billion market, the vast majority of which are unregulated for quality and safety.

 

What are the factors driving the growth of Medical Devices sector?

 

  • Market Factors– Growing population, ageing, income base and associated disposable income, increasing socio-economic inclusion of rural and deprived in mainstream economy, heightened manufacturing innovation to create customized products to meet the needs of all income segments, changing disease prevalence pattern (e.g. early onset of diabetes and heart diseases) and growing awareness among the middle class to focus on early detection and disease prevention.

  • Non-market Factors– Development of infrastructure, favorable regulations, FDI inflow, outsourcing of manufacturing and R&D activities to India, government initiatives to improve healthcare access through insurance schemes such as Rashtriya Swasthya Bima Yojana (RSBY), Aarogyasri, etc.


Which are the salient features?


  • At present, only 23 medical devices have been classified as drugs. The latest notification gives a wide definition of the term medical devices.

  • The devices used for diagnosis, monitoring, treatment, assistance for any injury or disability, investigation, replacement or modification or support of the anatomy or of a physiological process will come within the scope of the definition of ‘Drugs’.

  • Medical equipment under this definition include implantable medical devices such as knee implants, CT scan, MRI equipment, defibrillators, dialysis machine, PET equipment, X-ray machine etc.

  • Primary intended action of the device in or on human body or animals should not be pharmacological or immunological or metabolic.

  • The aim is to regulate all medical devices so that they meet certain standards of quality. 

  • Besides it will also make medical device companies accountable for quality and safety of their products.

  • The manufacture, import and sale of all medical devices will now need to be certified by the Central Drugs Standard Control Organisation.


What are the possible impacts?


  • The decision is going to have a major impact on the small and marginal players, largely unorganised, in the low-value high volume segment of the medical devices industry.

  • The hi-tech diagnostic imaging sector is dominated by large players and will be the least impacted.

  • Concerns are being raised that the rules are very rigid and any non-conformity can be treated as a criminal offence by any drug inspector under the Act at his discretion.


Conclusion


Merely expanding the scope of regulation to all devices is not enough in a moment of growing number of safety disasters involving devices. Hence, there is a pressing need for framing of a new medical devices act.


 
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