Medical devices and implants were in the limelight this week in the pharmaceuticals space. They are crucial pieces in healthcare delivery, but the sector never got the attention it deserved from the government. That all changed when the Union government on February 8 issued notification to regulate the sale, manufacture and import of medical implants and devices. The notification covers implantable medical devices, CT scanning equipment, MRI equipment, defibrillators, dialysis machine, PET equipment, X-Ray machines and bone marrow cell separator under the purview of the Drugs and Cosmetics Act, 1940. The government’s decision will ensure that medical devices and implants used in India are safe and tested, by bringing all these devices under Indian drug regulator Central Drugs Standard Control Organisation (CDSCO). The agency will become the approving agency for the import, manufacture and sale of the devices in the country. At present, there aren’t any specific acts to regulate medical devices in India. The Central Drugs Standard Control Organization (CDSCO) regulates medical devices under the Drugs and Cosmetics Act, which was meant only for pharmaceutical products. The notification was an outcome of a closed door meeting called on the same day by the Drug Controller General of India (DCGI) to prepare a road map on the regulations of medical devices. The meeting was attended by various industry associations.
Only 23 out of over 5000 categories of devices and implants are regulated incorrectly as drugs. The recent controversy over Johnson & Johnson’s alleged faulty ASR hip implant has brought to light the loopholes of the medical devices industry. However one have to wait till April 2020, when the notification will come into effect. Medical devices are quite different from pharmaceutical products with a lot of engineering, shorter product lifecycle and incremental improvements. India’s drug regulator usually follows American and European regulations to approve an implant or device. In addition, medical devices are covered under the Consumer Protection Act and Legal Meterology Act. “The majority of medical devices are completely unregulated in India. With this move, all implantable devices and some diagnostic equipment will be brought into the regulatory framework, which is important from a patient safety perspective,” said Malini Aisola, Co-Convenor, All India Drugs Action Network (AIDAN). India’s medical equipment sector is still emerging and dominated by imports. The sector in India is worth a mere USD 4 billion compared to China which is around USD 18.8 billion in 2016 and is expected to USD 24 billion by end of 2019. – Money Control