Incompatibility of the arrangements of sub-control (2) of rule 18 of the Medical Devices Rules 2017, the government of Maharashtra as created a rule where a notification is circulated to all the appointed drug inspectors under subsection (1) of section 21 of the Drugs and Cosmetics(D&C) Act, 1940 as the medical device officers for actualizing said rules.
As of now, there are 161 authorized posts of drug inspectors in Maharashtra and 21 in Mumbai.
The much-anticipated government notice is trailed by Maharashtra Food and Drug Administration (FDA) having prior assigned 100 drug inspectors, seven assistant commissioners and seven joint commissioners as licensing specialists to implement MD Rules.
With the help of notification, the state drug regulator is currently all set to execute the new MD Rules 2017.
New MD Rules 2017 was notified a year ago and has become effective from January 1, 2018, onwards in the nation. Following the notice, issues identified with post allow compliance; data protection, product recalls and product liabilities among others will be actualized adequately towards device or product safety.
As a combined section of manpower up-gradation, the state regulator has likewise requested 400 more drug inspectors in the current field power to manage compliance in a more effective way.
According to the new principles, state licensing authority needs to send applications to the notified bodies selected by the central government for inspections and auditing of Class A and Class B classification medical devices for compliance. Class C and Class D classification are examined by the Central Drugs Standard Control Organization (CDSCO).
Maharashtra FDA had likewise before asked the CDSCO to notify bodies, officers, and labs assigned of overseeing the compliance of new MD Rules, 2017 in the country.
Intertek India Pvt Ltd and TUV Rheinland India Pvt Ltd are the notified bodies enlisted with the CDSCO to do examining of manufacturing sites according to the arrangements of new MD Rules.
New MD Rules 2017 cover medical devices as well as in-vitro diagnostics, disinfectants, surgical sutures, ligature, condoms, bandages, etc. It sets new principles for manufacturing and use of medical devices.
