BioSpectrum India Magazine November issue BioSpectrum India Magazine - Page 25

www.biospectrumindia.com | November 2017 | COVERStory BioSpectrum with international practices and, like clinical trials, these will be regulated by CDSCO. Conduct of clinical investigations will, while following the international practices, be conducted in a manner that ensures realization of the twin objectives of patient safety and welfare and discovery of new medical devices. Medical management and compensation will be provided to the subjects of clinical investigation in accordance with the predefined and objective criteria laid down by the fovernment. The new Rules have many other unique features. It will be for the first time that there will be no requirement of periodic renewal of licences. Accordingly, manufacturing and import licences will remain valid till these are suspended or cancelled or surrendered. Further, the entire process starting from submission of application to grant of permission/licence will be processed through online electronic platform. Timelines have been defined for most activities at the regulators end. The issuance of licences for Class A medical devices on the basis of self-certification coupled with a system of checks and balances for ensuring compliance is a departure from the inspection based regulatory regime. Risk based audit of manufacturing units will be carried out to assess conformance with standards and quality parameters. These Rules envisage creation of a robust eco-system for all stakeholders including innovators, manufacturers, providers, consumers, buyers and regulators. Reacting to the notifications of the health ministry Anil Jauhri, CEO, National Accreditation Board for Certification Bodies (NABCB) said, “The Rules will provide a conducive environment for fostering LIST OF NOTIFIED MEDICAL DEVICES 1. Disposable Hypodermic Syringes 2. Disposable Hypodermic Needles 3. Disposable Perfusion Sets 4. In vitro Diagnostic Devices for HIV, HBsAg and HCV 5. Cardiac Stents 6. Drug Eluting Stents 7. Catheters 8. Intra Ocular Lenses 9. I.V. Cannulae 10. Bone Cements 11. Heart Valves. 12. Scalp Vein Set 13. Orthopedic Implants. 14. Internal Prosthetic replacements 15. Ablation Devices In addition to the above medical devices, the following substances are also regulated as ‘Drugs’ under Drugs & Cosmetics Act, 1940 & Rules, 1945 there under:- 1. Blood Grouping Sera 2. Skin Ligatures, Sutures and Staplers 3. Intra-uterine devices (Cu-T) 4. Condoms 5. Tubal Rings 6. Surgical Dressings 7. Umbilical Tapes 8. Blood/ Blood Component Bags Source: http://www.nishithdesai.com India specific innovation and improving accessibility and affordability of medical devices across the globe by leveraging comparative cost advantage of manufacturing in India. The objective, transparent and predictable regulatory framework will boost the confidence of investors and, as a consequence, the quality and range of products and services will improve and business burdens will be reduced. The new Rules will help in developing a quality standardization framework in India at par with international standards. The implementation of these Rules will provide the assurance of the best quality, safety and performance of medical devices.” These Rules coupled with other measures, taken by the government in the recent past, are expected to sharpen the competitive edge and provide incentives to firms to become more efficient, innovative, and competitive. All this will support entrepreneurship, market entry and economic growth that, in turn, would produce high-paying, high-quality jobs. Reacting to the announcement of the Medical 25