Becton Dickinson India Pvt Ltd (BD India) expressed interest to work with the Union government for training of inspectors at the office of DCGI and state regulatory departments on medical devices. With legislation on medical devices expected shortly, the training will help the inspectors to have a clear idea about the regulations, auditing quality systems and surveillance of these products.

The training programme follows DCGI warning on clamping down violators in the medical devices sector who operate without licenses. A Confederation of Indian Industry (CII) forum for medical equipments mainly constituted by global majors has been asked to associate itself in the initiative. Assessing the importance of training in the sector, BD India is chipping in its expertise.

In this regard, BD India could team-up with either CII or Federation of Indian Chamber of Commerce (FICC) to train drug inspectors. A regional inspectorate from BD Singapore is expected to be in India by the year end to educate team of inspectors under the Asian Harmonization Working Panel.

Early this year, APEC-funded a seminar on Harmonization of Medical Device Regulation where the role of regulators, industry and distributors on the Harmonization of Medical Device Regulation in the Asia/Pacific Region was discussed at Kuala Lumpur. BD intends replicate the same for a local audience in the country.

The inspectors have the experience in undertaking massive checks of pharmaceutical products. Now with the medical devices regulation round the corner, the training of inspectorate staff in the DCGI is vital. There is a need to increase the knowledge about the regulatory process, understand the novel features and functioning of the medical devices, Ram Sharma, managing director, BD India told Pharmabiz.

The medical devices training programme will help to educate both regulators and industry professionals. There will be interactive discussion between instructor and inspectors to provide guidance on the role of regulators, industry and distributors about the adherence of norms in the medical devices supply chain.

BD has been engaged in conducting seminars to educate health workers and paramedical staff on the use of safety engineered devices and needle-based syringes.

The company, which took off operations in India in 1996 has set up Asia's largest syringe and medical device manufacturing plant at an investment of $100 million at Bawal near Rewari in Haryana. A range of disposable needles, syringes and catheters like SoloShot LX auto-disable syringes and BD Venflon Pro Safety IV Catheter with safety features against needle stick injury are produced here. The products are utilized for the national immunization projects including TB control and National Aids Control Organization for CD4 monitoring for HIV cases. For the automation in the diagnosis of TB, BD offered the BACTEC System which has helped to identify the strains resistant to anti-TB drugs in 7-10 days rather than the 21 days using a manual method.