India Looks to Tighten its Medical Devices Regulations with New Regulations, Resources, and Structure - Experts Say it Will Take Several Years

April, 2019

Medical devices manufactured in India or imported from other countries might need to go through the safety and quality standard testing as suggested by the India’s highest drug advisory body – Drugs Technical Advisory Board (DTAB) under Central Drugs Standard Control Organisation (CDSCO) and overseen by Ministry of Health and Family Welfare (MoHFW). Further to this, the current government is also planning to hire over 700 regulatory officers to exclusively monitor the efficacy and quality of the medical devices in India.

According to the proposal by DTAB, the suggestion is to form new division under the CDSCO, the national regulatory authority for drugs and medical devices. The new officers will work under this division which will be exclusive and only for medical devices in India and in critical ones such as coronary stents, pacemakers, orthopedic knee and hip implants, structural heart devices, peripheral devices, endoscopes, in vitro diagnostic devices, and various other types of medical devices.

It is to be noted that the above decisions are considered because of various controversies among the medical devices category and the faulty Johnson & Johnson Articular Surface Replacement (ASR) hip implants in which more than 4,000 patients were affected by the faulty device.

If the proposal to notify medical devices as drugs under the Drugs and Cosmetics Act (DCA) comes in force then imports, manufacturing, and sale of all medical devices will need certification by the Central Drugs Standard Control Organisation (CDSCO). Apart from this, companies will also need licences from the Drug Controller General of India (DCGI).

According to industry experts, the current resource strength at CDSCO is not even half of the planned resources and more than 400 out of the 700 officers are expected to oversee regulatory tasks such as audits at manufacturing sites, import approvals, cancellations, and approval of licenses etc. Whereas, the rest will be deputed at national laboratories to test the safety and efficacy of the medical devices as mentioned by the manufacturers during the submissions.

The proposed structure of the new division (as per DTAB) is shown below:

 structure of the new division

The DTAB also has suggested to hire specialist (physicians/surgeons) across therapeutic segments such as orthopedics, dermatology, surgery, biomedical engineering/medical imaging, cardiology, and biocompatibility experts on adhoc basis.

However, the industry experts feel that the new division might take several years to form and start its operations. According to the industry experts it can easily take between five to ten years in order to create the infrastructure and have the required resources working in it. Apart from this many are not in favor of increasing the size of the existing regulatory framework which can increase complexity and lengthen approval times.

There are around 20 medical devices which are currently regulated in India. In February 2018, devices such as implantable medical devices, CT, MRI, defibrillators, dialysis machines, PET/SPECT, X-ray machines, and bone marrow cell separators have come under the purview of the DCA and will be notified as drugs in a phased manner by 2020. Surgical gowns, surgical drapes, and incision drapes will also be notified under the Act. However, many of the medical devices like equipment, analyzers etc are still not included in the scope.

The overall medical devices market in India is a multibillion industry. The medical devices market is segmented into clinical pathology or in vitro diagnostics (IVD reagents and equipment) and radiology or in vivo (diagnostic imaging) testing devices. The IVD market is further segmented into clinical chemistry, molecular diagnostics, immunoassay, microbiology, coagulation analysis, hematology, urinalysis, and other types of testing technologies; and by therapy areas such as cancer, infectious diseases, diabetes, cardiology, nephrology, virology, immunology, and others.

The IVD market in India is currently valued over US$6 billion and is expected to grow to more than US$8 billion by 2020, mainly because of rising healthcare expenditures, possible upcoming medical devices related policies to support domestic manufacturing, expanding healthcare access in tier-II and tier-III cities, increasing investments from healthcare providers, and diagnostic labs at new locations outside saturated markets. The share of IVD equipment in India in the in vitro market is expected to increase slightly from 31% in 2018 to 32% in 2020. The overall immunochemistry market is expected to grow at a rate of between 13% and 14% during 2019 and 2020. In the long-term scenario, in vitro diagnostics market in India is expected to grow at a CAGR between 12% and 15% during the forecast period 2019–2025.

With India’s focus on eradicating TB from the country, the expenditure on TB testing is from US$115–US$140 million inclusive of both public and private segments and is expected to increase multiple folds during 2019 and 2020.

Apart from the factors mentioned above, the Indian IVD market is immensely driven by the increase in the number of chronic and lifestyle-related disorders, increasing cancer incidences, growing awareness on the importance of early diagnosis and prevention, and improving access to healthcare facilities and diagnostic set-ups.

– Vivek Sharma,
Manager - Healthcare Research,
Infoholic Research