Press Release

Bangalore, 29 Dec 2021

REGULATION OF MEDICAL DEVICES

80–90% of the $15 billion in imported medical equipment is from India, and the vast majority of it is subpar in terms of quality and safety. Despite the fact that many of these products may have regulatory certificates in other countries, the truth is that a large number of these products are shipped from countries that do not regulate their exports. Currently valued at $15 billion (Rs 105, 000 crores), the Indian market for medical equipment is expected to grow to $50 billion by 2025. The market is the fourth-largest in Asia.

Thirty years have elapsed since the first medical gadget was categorised as a drug in 1989. A thorough regulatory framework is almost here with the Draft Medical Devices (Safety, Effectiveness & Innovation) Bill from NITI Aayog shortly to be submitted as a separate law. Even after the most recent USFDA ban on Trans-vaginal Pelvic Mesh, the J&J event, and the ICIJ implant data, our lawmakers in the Health Ministry were startlingly unsure and didn't seem to be in a hurry to pass a "Patient Safety Medical Devices Law" to safeguard patients. The Draft Medical Devices Bill, which Niti Aayog is reportedly working on in cooperation with other stakeholders, departments, and ministries to solve the regulatory vacuum and the national patient shortage, is eagerly awaited by those in the business. It was unexpected that the Ministry of Health & Family Welfare (MoH&FW) chose to alter the Drugs Act rather than drafting a new law, and CDSCO has an interest in strengthening itself. Given that gadgets are technical goods rather than pharmaceuticals, it is imperative to have a specific regulation. Any attempts to regulate an MRI or CT scan machine as a drug are unreasonable and wrong, unless it is made clear that they are being used just briefly. A beginning was made to correct the anomalous situation with the introduction of the Medical Device Rules in 2018. These rules offer risk-proportionate controls based on the risk rating of devices. Because you cannot impose the same penalties for a manufacturing fault in a pair of spectacles as you would for a contact lens or an intraocular lens, the law and punishment must also be risk-proportional. With regards to gadgets, patient safety is more challenging because to the fact that the manufacturer, physicians, patients, and regulators all share responsibility for it. The Drugs Act needs to be changed because it does not consistently and equitably regulate quality from state to state in the absence of a national single regulatory authority, thus there is no use in replicating this restriction for devices as well.

Policymakers still need to make sure that technology and drugs are of a high standard and are safe, despite starting to view them differently. The ministry of health regulates food, so they should consider doing the same for electronics. The FSSAI, which has a secretary-level chairman and CEO, instead of the Drugs Act, DCGI, or CDSCO, is in charge of regulating food. A strong and fair regulatory framework would aid the Make in India initiative by encouraging the growth of this industry. From trade margin reduction to ensuring a specific set of laws and regulatory frameworks to manage the medical device sector, everything needs to be reexamined to promote domestic manufacture. Piecemeal reforms are ineffective, and continuing to regulate devices under the Drugs Act without a commitment to enacting separate legislation will do more harm than good for the Make in India initiative. If we are sincere about turning India become a major global centre for the production of medical equipment.

About Startoon Labs

Startoon Labs, an organisation founded in Hyderabad, India, specialises in the development and production of medical equipment. This business was created by IIT and IIM graduates with the goal of developing top-notch healthcare goods and solutions. Startoon Labs, one of the top startups in Telangana, was incubated by WE Hub and is supported by DBT, Meity, and the Indian government. Startoon Labs has received praise on both a national and international level for producing the Pheezee product, which has won awards. Its ground-breaking product, PHEEZEE, has as one of its primary features the ability to track and monitor the healing process of patients undergoing physical therapy, post-neurological rehabilitation, and musculoskeletal rehabilitation.

Website - https://startoonlabs.com/pheezee.php