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WHO backing helps manufacturers from developing countries thwart MNC bid to alter ISO definition for AD syringes
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Arun Sreenivasan, New Delhi
December 12 , 2018
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Medical device manufacturers from India and other developing countries have thwarted an attempt by multinational companies (MNCs) to alter the International Organisation for Standardisation (ISO) definition for auto-disable (AD) syringes to gain strategic competitive advantage in the market, it is learnt.
If the change in definition of AD syringes was implemented, more than 60 per cent of the existing World Health Organisation (WHO) performance, quality and safety (PDS) designs would have been disqualified despite being auto-disable, which would have adversely impacted global immunisation campaigns and supply security. Furthermore, the revision would have favoured a few MNCs and put syringe makers from the developing world in jeopardy.
Manufacturers from Indonesia, Bangladesh, Pakistan and Kenya have joined hands with the Indian industry, led by Hindustan Syringes and Medical Devices Ltd, in opposing the move with the active backing of the WHO, an ISO committee member who attended the meeting told Pharmabiz on condition of anonymity. Thanks to their concerted and determined effort, the ISO Technical Committee has decided not to go ahead with the proposed revision of ISO 7886-3 Standard of AD syringes for fixed-dose immunisation at its recent meeting in San Jose, California.
The Indian delegation on behalf of Bureau of Indian Standards was led by Rajiv Nath, Forum Coordinator of AiMeD and Joint Managing Director of Hindustan Syringes and Medical Devices Ltd.
Currently, the ISO 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 (WG11) that was looking into the review of ISO 7886- 3 Standard of AD syringes had 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 the change was incorporated in the initial Committee Draft of the standard. If the change was implemented, those few manufacturers who produced the newly defined type would have got a huge competitive edge. It is interesting to note that two of the four-member expert panel were from Becton Dickinson and Terumo, producers of the defined type of AD syringes.
While passing the resolution to retain the existing definition, the technical committee has acknowledged the lack of consensus in WG11 regarding the proposed changes and observed that revision should be initiated only if data from new studies indicate the need for such a step.
Indian medical device manufacturers have been resisting the ISO move to redefine AD syringes. The UN health agency has concurred with them and asked the ISO to avoid the intended amendment.
Indian domestic industry representatives have expressed relief over the ISO resolution. “We are thankful to the WHO for their unstinting support to WHO PQS manufacturers of AD syringes in blocking and reversing this strategic change to the definition, which would have jeopardised patient safety and access to affordable homegrown products. HMD is the world’s largest manufacturer of AD syringes and this status may have become questionable if the US MNCs’ nefarious game-plan succeeded,” Nath added.
In a letter to the ISO emphasising its stance on the issue, the UN health agency reaffirmed its view that “the definition of the AD activation point should remain unchanged as there is no evidence to support a change”.
“We note that ISO 7886-3 has been in use for over a decade and the WHO specifications on which the standard was built had been in place for almost a decade before that. In the twenty years of AD syringe use in member states, with billions of devices used by countries, no evidence of a link between AD mechanism activation point and injection safety has been shown,” the letter, a copy of which was reviewed by Pharmabiz, noted, adding that the proposed change would have a significant negative effect on global supply security and sustainability.
The WHO has pointed out that Unicef Supply Division, the largest supplier of AD syringes, has a rigorous quality assurance system that monitors complaints and the health agency’s prequalification system includes post-market monitoring to report defects. Over the past 20 years, these diverse and independent avenues have provided no verified documented evidence of any safety or public health issues with AD syringes.
Questioning the rationale for the revision, which was based partly on a white paper indicating that users failed to activate the blocking mechanism, the UN agency observed that the reports did not clearly associate lack of activation with the type of technology.
The ISO decision is a big relief for India and many other nations. A major part of the 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.
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