The Government of Andhra Pradesh notifies a site for common Hazardous and Other Waste Treatment Storage and Disposal Facility
The Government of Andhra Pradesh in its Gazette notification dated 1st November 2019 has notified a site in Nellore district for storage and disposal of Hazardous waste.
CDSCO Notifies that Ethics Committees which have applied for re-registration/ renewal of the registration will remain valid until Order passed by CDSCO
The Central Drugs Standard Control Organization has issued a Notice on 18th October 2019, specifying that Ethics Committees that applied for re-registration/ renewal of the registration will remain valid until an Order is passed by CDSCO.
Government laboratories exempt from accreditation for two years; Medical Devices Rules amended
The Ministry of Health and Family Welfare has published the Medical Devices (Fifth Amendment) Rules, 2019 to exempt government laboratories from accreditation of National Accreditation Board for Testing and Calibration Laboratories for next two years.
MOHFW issues draft notification to bring all medical devices under single regulatory framework
The Ministry of Health and Family Welfare (MoHFW) has issued Draft Notification to notify the specified devices indented for use in human being or animal as “DRUGS “under section 3(b) of the Drugs and Cosmetics Act, 1940(
Effective from November 01, 2019, Ultrasound Equipment will qualify as ‘drug’ under The Drugs and Cosmetics Act
The Ministry of Health and Family Welfare, has specified ultrasound equipment device intended for external or internal use in human beings as “Drug” under Drugs and Cosmetics Act, 1940.
CDCSO Issues list of medical devices testing laboratory to carry out test or evaluation of medical device
The Central Drugs Standard Control Organisation (“CDSCO”) in its notification dated 3rd October 2019 has added four laboratories to the list of medical devices testing laboratories who shall carry out test or evaluation of medical device on behalf of manufacturer registered under CDSCO.
NCT Delhi Classifies laboratories by Corrigendum on public notice issued on 12.12.2018
Directorate General of Health Services, NCT Delhi, by Corrigendum on public notice issued on 12.12.2018, Classifies laboratories and clarifies the signing authority and their required qualification in each category of laboratory.
NDPS (Regulation of Controlled Substances) Amendment Order, 2019
Narcotic Drugs and Psychotropic Substances (Regulation of Controlled Substances) Order, 2013. The amendment has been brought in order to control online sale/ purchase of through website, social media or in any other manner of any controlled substance included in Schedule-A.
MOHFW Notifies the Medical Device (Fourth Amendment) Rules 2019
The Ministry of health and family welfare in its notification dated 13th September 2019 has amended the Medical Device Rules, 2017 by amending the licensing authority for issue of license in Form MD-10 which is related to loan license to manufacture and distribute class C or Class D medical devices from state license authority to central.
Orthopedic Knee implant price allowed to include trade margins NPPA clarifies
The National Pharmaceutical Pricing Authority (NPPA) has released a clarification on the pricing of orthopedic knee implants in an office memorandum dated 29th August, 2019. NPPA has clarified that hospitals, nursing homes and clinics are allowed to add trade margins on orthopedic knee implants as per the rates prescribed.
