Parliament Question: Regulation and Patient Safety in Dental Implantology

GOVERNMENTOFINDIA MINISTRYOFHEALTH AND FAMILYWELFARE DEPARTMENTOFHEALTH AND FAMILYWELFARE LOK SABHA UNSTARREDQUESTION NO. 3350 TO BE ANSWERED ON 07THAUGUST, 2026 REGULATIONANDPATIENTSAFETYINDENTALIMPLANTOLOGY

3350.SHRIPARSHOTTAMBHAI RUPALA:

Will the Ministerof HEALTH AND FAMILYWELFAREbe pleasedtostate:

(a) whether the Government is aware of the absence of a comprehensive national regulatory framework governing dental implants, implant biomaterials, artificial teeth and implantology practices,resulting inpotential patient-safetyrisks, if so, the detailsthereof;

(b) whether the Government proposes to mandate scientific evaluation of implant devices, including fatigue, biocompatibility, sterility and corrosion testing and establish a National Dental Implant Registry with mandatory device traceability and adverse-event reporting, on the linesof international best practices,if so, the detailsthereof; and

(c) whether the Government proposes to prescribe mandatory practitioner certification, accreditation of implant centres, standardized informed-consent protocols and ethical advertising normsfor dentalimplant procedures, if so, the detailsthereof? ANSWER THE MINISTER OFSTATE IN THE MINISTRYOFHEALTH AND FAMILY WELFARE (SMT. ANUPRIYAPATEL)

(a)& (b): All Medical Devicesincluding dentalimplants, implantbiomaterials, artificial teeth etc., are regulated under the provisions of Drugs and Cosmetics Act 1940 and Medical Devices Rules 2017, regarding quality, safety & performance of the Medical Devices in the country.

Under the said rules, requirements of scientific evaluation of medical devices including implantable medical devicesare prescribed and the manufacturerhas toperform all the tests applicable as per existing standards for biocompatibility, sterility along with other tests asapplicable for itscompliancebefore grant of license. The scope of standards, essential principles for safety & performance and Quality Management System (QMS) are mandatory for ensuring the safety & quality of the medical device throughout the device life cycle.

Further, the existing rules are aligned with global regulatory practices followed by stringent regulatoryauthorities.As regard to adverse-event reporting mechanism, the Indian Pharmacopoeia Commission (IPC), functions as the National Coordination Centre (NCC) for the Materiovigilance Programme of India (MvPI). The programme collects and analyses suspected adverse event associated with medical devices, including devices used in dentistry toensure medicaldevice safety.

Further, as part of Quality Management System (QMS) implementation, the manufacturer has to adhere to the requirements of Quality Risk Management for vigilance reportingand all Adverse Events (AE) are monitoredbythe manufactureraspertheir Quality Risk Management protocol. The manufacturer also needs tosubmit Post Market Surveillance

(PMS)report mentioningall Adverse Events tothe Licensing Authority, for ensuring Quality, safety & performance of the Medical Device throughout the product life cycle.

(c): As prescribed at present, any registered Dentist may perform dental implant procedures. *******