MoH Extends Date For Comments On Draft Guidance Document For Medical Devices Till Sept 25

New Delhi, 10 Sept 2018: Industry experts and stakeholders can submit suggestions on the ‘first-of-its-kind’ reference document that spells out standards for medical devices in the country till September 25. 

The Indian Pharmacopoeia Commission (IPC), an autonomous body under the Union Health Ministry that prepared an exhaustive draft, has extended the deadline by another 25 days to give industry more time to review the norms. The ministry has brought out the first quality guidelines for medical devices nearly eight months after the implementation of the Medical Device Rules 2017. 

Stakeholders can send their inputs on the feedback form that can be downloaded from the official website of the IPC. 

The 241-page draft rule book intends to provide manufacturers, licence holders, regulators and healthcare professionals with requisite information on regulatory and technical requirements under one umbrella. In addition to the new MD Rules, the document is based on the standards adopted in Indian Pharmacopoeia 2018, British Pharmacopoeia, Japanese Pharmacopoeia, European Pharmacopoeia and the Bureau of Indian Standards. 

The document has elaborate sections on classification, registration process, grouping and labelling. More than 20 pages are dedicated for classification of devices and quality parameters. The medical devices on the list are classified into categories A, B, C and D depending on the risk factor. They include ablation devices, catheters, bone cement, cardiac stents, contraceptives like tubal and fallopian rings, male and female condoms, disinfectants, disposable hypodermic needles, heart valves and internal prosthetic replacements like penile, dental, vaginal, breast, retinal and cochlear implants.

Currently, India’s medical device sector is dominated by multinational companies, which is evident from the fact that about 80 per cent of the sales are generated by imported devices. Though many multinationals have set up operations in India over the years, a majority of them focus on distribution of imported devices and support functions. The MD Rules 2017 were framed around the guidelines of the Global Harmonisation Task Force to ensure that the Indian norms are on par with those in vogue globally. Against this backdrop, the new reference document will come in handy since the industry is growing at a rapid pace and there is need for an easy-to-access guidebook on regulations and export-import guidelines, say industry observers.

The reference manual is the latest step from the Union health ministry to ensure the reliability of medical devices available in the domestic market. Plans are afoot to bring all implantable medical devices and other critical medical equipment under the purview of the Drugs and Cosmetics (D&C) Act 1940 and the Central Drugs Standard Control Organisation has notified the list of devices to be regulated under the Act. Apart from all medical implantables, the list includes defibrillators, bone marrow cell separator, dialysis and X-ray machines as well as PET, CT scan and MRI equipment.Pharmabiz