Indian certification of medical devices to boost indigenous medical device industry

Medical Devices

As a step towards protecting industry from faulty medical devices and reliance on international certifications, Andhra Pradesh MedTech Zone (AMTZ) has signed an MoU with the Quality Council of India (QCI) to promote Indian Certification for Medical Devices (ICMED) Scheme in India.

Developed in collaboration with Association of Indian Medical Device Industry (AIMED), India’s apex quality facilitation and national accreditation body Quality Council of India (QCI) and the National Accreditation Board for Certification Bodies (NABCB), ICMED is a quality certification scheme for medical devices in the country with an aim to enhance patient safety, and increase consumer protection along with providing much needed product credentials to manufacturers to instil confidence among buyers.

The scheme is also intended to significantly eliminate trading of sub-standard products or devices where supply chains are unknown, a widespread and injurious occurrence in the Indian market.

QCI on March 15, 2016 launched the voluntary certification scheme named ICMED - the first indigenously developed international class certification scheme for the medical devices in India to reduce time and cost-run for obtaining globally accepted quality certification for Indian companies thus eliminating the malpractices of sub-standard or fraudulent certification or quality audits.

ICMED will also fill a big regulatory void as there was no India-specific official quality assurance system till date, due to which Indian medical device manufacturer’s encountered loss of competitiveness to foreign companies while consumers ended up paying extra premium with no concomitant benefits.

Andhra Pradesh MedTech Zone (AMTZ) at Visakhapatnam which is India's first medical devices manufacturing park would include facilities such as component testing centre, electro-magnetic interference laboratory, medical grade low vacuum molding, cabinet moulding, injection moulding centres, 3D designing and printing for medical grade products, sterilization and toxicity testing centre, radiation testing centre, gamma irradiation facility, rapid prototyping centre, warehousing and regulator’s office.

Meanwhile, the Union health ministry notification of the Medical Devices Rules, 2017 which will come into force from January 1, 2018, is of great significance to the medical devices industry.

One of the major complaints of the medical device suppliers all these years, has been the absence of a regulatory and quality testing mechanism, that was distinctively different from the one existed for drugs and pharmaceuticals. The point they tried to emphasize was that these two categories were entirely different and medical devices itself was a term used for a wide range of electrical and mechanical products.

Their long standing demand was also to have a certification mechanism that was similar to what exists in other countries, especially advanced economies. The Medical Devices Rules 2017 has addressed that problem. The new set of rules, which will come in force in the next 12 months, has been framed in conformity with Global Harmonisation Task Force (GHTF) framework and conform to best international practices.

Medical devices will, under the new rules, be classified as per GHTF practice, based on associated risks, into Class A (low risk), Class B (low moderate risk), Class C (moderate high risk) and Class D (high risk). The manufacturers of medical devices will be required to meet risk proportionate regulatory requirements that have been specified in the rules.

Medical device testing lab complements ICMED

After commerce ministry sanctioned Rs. 15 crore for the manpower and lab infrastructure, HLL, a subsidiary under Union health ministry, initiated the process to procure testing equipment for country’s first dedicated medical device testing lab at Vadodara.

This comes at a time when land for the upcoming medical device park at Sanand near Ahmedabad has also been allocated. The Centre has been mulling for quite some time for setting up the medical devices park in Gujarat in a bid to make India self-reliant in the sector.

To help get trained manpower for its upcoming medical device park, Gujarat Food and Drug Control Administration (FDCA) has also tied-up with National Institute of Pharmaceutical Education and Research (NIPER), Ahmedabad.

Medical device testing lab at Vadodara in Gujarat would be the first and the only dedicated biomaterials and implants testing lab in the country. The testing lab will be housed at Gujarat FDCA office located strategically in the middle of a thriving industrial belt.

The idea of setting up the lab was initially mooted at an Engineering Export Promotion Council (EEPC) meet at Ahmedabad some time ago to ensure quality assurance of medical devices manufactured in the country.

Medical devices are usually sent to foreign countries for testing due to lack of a reliable and advanced medical device testing facility in the country. Few testing labs in the country which claim to offer testing are obsolete and not up to the mark, as per a survey done by NHSRC officials.

Though the government plans to set up two medical device testing labs in the country, one at Vadodara in Gujarat and another at Noida, the one at Noida one will be set up primarily to test electrical and electronic medical devices in the country.

CLAA scheme and ICMED

Meanwhile, Gujarat has also achieved a rare distinction of having the highest number of 150 licensed medical device units under Central Licensing Approval Authority (CLAA) scheme as against a total 284 medical device units in the entire country. The state earlier had 130 units and added another 20 units recently.

Other states following Gujarat however have less number of units with 26 in Haryana, 18 in Uttar Pradesh, 17 in Maharashtra, 15 in Tamil Nadu and 10 in Kerala out of the 19 states having medical device manufacturing units.

CLAA has been formed to oversee the regulatory activities related to grant of manufacturing license for hi- tech medical devices in India. It aims at ensuring that the medical devices being manufactured in India follow the standard requirements set by the government to ensure safety, efficacy and quality of the devices.

The Central Drugs Standard Control Organization (CDSCO) released a guidance document on August 7, 2015 to file an application for grant of the license for manufacturing of medical devices in India.

The devices currently regulated under CLAA scheme include cardiac stents, drug eluting stents, catheters, intra ocular lenses, I.V. Cannula, bone cements, heart valves, scalp vein set, orthopaedic implants and internal prosthetic replacements.

Since there is no dedicated medical device testing lab in the country, the country today lacks in registering and thereby reporting adverse events due to faulty medical devices at the point of care.

In order to comply with all safety requirements, set of universal standards and norms have been prescribed, compliance to which ensures delivery of right technology in the right way. A means to verify the devices against this desired compliance is testing.

Setting up of a dedicated medical device testing lab in the country would be a boon for the Indian manufacturers to help adhere to compliance towards patient safety.

Apart from procurement of equipment, the lab will further develop in partnership with Union health ministry with technical support from Healthcare Technology Division of National Health Systems Resource Centre (NHSRC).

Complementing the growth, Gujarat FDCA has added another 20 licensed manufacturers under the CLAA scheme raising the bar of new hi-tech medical devices in the country. High quality and skilled manpower in the country is one of the critical requirements in the medical devices sector today as more than 70 per cent of devices are imported as of today which is impacting the development of the domestic industry.

 

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