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WHO Supports Manufacturers from Developing Countries In Defining AD Syringes

If the change in definition of AD syringes by International Organisation for Standardisation (ISO) 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.

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.

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.

Indian Device Maker Meril Life Sciences Joins Big League With Artificial Heart Valve Technology

Meril last month received an approval from Indian drug regulator Central Drugs Standard Control Organization (CDSCO) for commercialization of Transcatheter Aortic Heart Valve Replacement, which will be sold under the brand name Myval.

Meril Life Sciences, India's top medical device maker, is all set to launch an indigenously developed and manufactured artificial aortic valve that regulates the blood flow in the heart.

Meril last month received an approval from the Indian drug regulator Central Drugs Standard Control Organisation (CDSCO) for commercialisation of Transcatheter Aortic Heart Valve Replacement (TAVR), which will be sold under the brand name Myval.

Meril not just developed the valve but the entire technology to replace the valve through a minimally invasive surgery on the lines of angioplasty.

Headquartered in Vapi, Gujarat, India, the company got CDSCO nod on the basis of almost three years of clinical study in India.

"All patients are doing well post procedure and during follow-up. This novel Myval technology is associated with Zero new pacemaker implantation rates post procedure which is an important benefit for the patient already treated for valve replacement," Meril said.

Pacemaker is an additional device that may be placed post TAVR procedure.

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