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At the state level we are working closely with Mr Chandra Babu Naidu , Chief Minister , Andhra Pradesh for an AMTZ medical device park with focus on medical electronics and equipment and also Mr Nitin Gadkari , Union Minister for a medical devices park at Nagpur with focus on orthopedics and surgical instruments . Gujarat , Himachal Pradesh , Karnataka and Haryana are next on the agenda . Once investing in manufacturing medical devices becomes profitable , the world will queue up to come to India .
Please update our readers on the need for reforms in medical technology sector in India ? What are the activities of AiMeD in this regard ?
Reforms are needed in regulations of medical devices to attract investors in this sector . At a high level meeting at the PMO in mid-July 2016 , industry representatives from AiMeD and other industry bodies such as CII and FICCI shared their common vision and thoughts on medical devices regulatory framework along with officials from ministry of health based on best international practices , confidence in medical devices available in India whether manufactured in India or imported , ease of doing business and patients safety .
We believe that manufacturers should aim to be voluntarily selfcompliant to ICMED voluntary certification or CE certification , this will ensure they have to do minimal changes to documentation and processes to be compliant to these rules . There has been a long outstanding demand from AiMeD for a separate rule book and separate law to regulate medical devices . These are now a given . The changes are being done in 3-4 phases .
The forthcoming bill later this year will cover the legislation part of
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The definition of
‘ manufacturer ’ as proposed by CDSCO in draft rules is in conflict with labelling defined in Weights and Measures Act and will be against ‘ Make in India ’ as it legalizes a Pseudo Manufacturer and allow traders or marketing company to be called and labelled as manufacturer which is unfair for actual manufacturer who have toiled and invested in Green Field Projects .
regulations for which government needs backing of Parliament . In case of these rules , the Government of India can amend rules without pre approval from Parliament . The major strategic elements are common in rules under drafting e . g . it permitted government to have powers to define rules to regulate through 3rd party certification bodies and consider a 4- tiered risk based proportionate regulatory controls . In essence , we welcome these separate set of rules as this has been a long outstanding request . There are however some challenges as these rules need to be tweaked to enable the dual needs of patient safety and ease of doing business to enable ‘ Make in India ’. In terms of key elements , they are getting aligned to some or all the major economies .
What are your reservations on the definition of ‘ manufacturer ’ in the regulatory draft ? What has AiMeD proposed on it and the way forward ?
The currently proposed rules seek a Central Regulatory Authority to regulate the Manufacturer and the Importer and delegates the Regulation of Trading Company to the State Licensing Authority .
Our proposal , in line with the Japanese Regulatory System , is that the IMDRA regulates the importer , the manufacturer ( and the specific manufacturer site ) and the Market Access Authorization Holder ( whether the MAAH is the Manufacturer or a marketing company or an authorized agent of the overseas manufacturer ) and the SLA regulates the domestic reseller – wholesaler or retailer or healthcare provider .
The definition of ‘ manufacturer ’ as proposed by CDSCO in draft rules is in conflict with labelling defined in Weights and Measures Act and will be against ‘ Make in India ’ as it legalizes a Pseudo Manufacturer and allow traders or marketing company to be called and labelled as manufacturer which is unfair for actual manufacturer who have toiled and invested in Green Field Projects . This definition of legal manufacturer coined in Europe has hurt the European Domestic Industry as complete product have been farmed out to a Manufacturer in China , India , Malaysia etc . and are claimed to be made by European company . Our proposal will enable regulation to be used strategically for driving ‘ Make in India ’ as is done by Japan for boosting and protecting their domestic manufacturers and labelling proposed by us is in line also with existing Weights and Measures Act .
These drafted Rules are under discussion and at drafting stage inviting consultations from key stakeholders . Next stage is notifications on their website , then public comment then final legally abiding notifications- the process can take minimal 3-6 months . As explained above this does not need pre approval of Parliament . These are exciting times and hopefully government will use the opportunity to address patient safety needs as well as those needed to enable ease of doing business and ‘ Make in India ’.
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BioVoiceNews | September 2016