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Indian manufacturers cry foul as MNCs try to alter ISO definition of AD syringes to gain upper hand

Arun Sreenivasan, New Delhi
Tuesday, April 17, 2018, 08:00 Hrs  [IST]

Multinational companies, which have been lobbying the US administration for watering down India’s pricing policy on medical devices, are now using their clout and resources to amend the International Organisation for Standardisation (ISO) definition for auto-disable (AD) syringes to gain strategic competitive advantage in the market, it is learnt. The proposed revision of ISO 7886-3 Standard of AD syringes for fixed-dose immunisation will favour a few multinational corporations and put manufacturers from India and other developing countries in jeopardy.

The ISO currently defines ‘auto-disable’ syringe as any syringe with a mechanism that disables it automatically in course of giving a full dose of injection either at start of an injection, during the injection or by the end of the injection. “A four-member expert sub-group of Working Group 11 that was looking into the review of ISO 7886- 3 Standard of AD syringes for immunisation opted to redefine them and limit them to those designs which had the mechanism to activate the AD function at the beginning of injection and this change was incorporated in the initial Committee Draft of the standard. By this change, over 66 per cent of the existing WHO Performance, Quality and Safety (PDS) designs could be disqualified despite being auto-disable, giving a competitive edge to those few manufacturers who produced the newly defined type. Two of these so-called expert members were from Becton Dickinson and Terumo. Both companies are producing the defined type of AD syringes,” an ISO committee member told Pharmabiz on condition of anonymity.

“ISO did not consult with major manufacturers in India and the latter came to know of the proposed change only when BIS informed them of the move. They immediately informed the WHO that the move would limit access to syringes with other innovative designs and, in the absence of any reports of an AD syringe reuse, the standard revision was uncalled for. Meanwhile we attended the next Working Group 11 meeting in Tokyo in May 2016 on behalf of India BIS but as only 2 countries, India and the UK, opposed the change we were unable to stop this from going ahead as the Committee Draft Standard,” the panel member pointed out.

Indian medical device manufacturers are strongly resisting the ISO move to redefine AD syringes. “Now the WHO has studied our complaint and concurred with us and asked ISO not to go ahead with the intended change. ISO has sought consensus to revisit this change which is not forthcoming as yet as both sides are sticking to their guns,” said Rajiv Nath, Forum Coordinator of Association of Indian Medical Device Industry (AiMeD) and joint managing director of Hindustan Syringes and Medical Devices.

The ISO Technical Committee will study the opinion of both sides at its next meeting in the US in December before taking a final decision on the issue, Nath added.

The ISO move is seen as a huge setback for the manufacturers in India and the developing world as a major part of Indian immunisation campaign and many tenders at national and regional levels in countries such as China, Indonesia, Nigeria, Vietnam, Bangladesh, Pakistan and Saudi Arabia are dependent upon local manufacturers with AD syringes which are not necessarily activated at the beginning of injection.

“If the intended mischievous change that disqualifies most WHO prequalified manufacturers goes forward in a Revised ISO Standards, the option for India is to have an Indian Standard on same lines as earlier or current ISO 7886-3 Standard. The WHO can also come out with a WHO PQS standard different from the ISO standards as they have for safety sharps boxes,” AiMeD forum coordinator opined.


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