ESIC issues Notice of Not of Standard Quality for specified batch of Vildagliptin Tablet lP 50mg
Employees’ State Insurance Corporation (ESIC) has issued a notice of Not of Standard Quality (NSQ) for the drug Vildagliptin Tablet lP 50mg having batch number VLD09H22. all concerned stakeholders are directed to stop use of the batch of the above item immediately. Further action as per clause for “Testing of Drugs-Quality Control” of Terms & Conditions of DG ESIC RC should be initiated. Replacement of supplies or cost of the material is to be recovered along with the testing charges (if any) from the firm. Additionally, any action taken is to be maintained in respective user unit.
NPPA further extends last date for filing statutory forms under DPCO, 2013
It may be recalled that NPPA had previously already issued an extension for the filing of these statutory forms under DPCO, 2013 on 30th December, 2022. Through the present OM, on the request of some of the pharmaceutical associations, the NPPA has further extended the last date for filing these statutory forms. The Authority emphasises that no further extension in time beyond 31st March, 2023 will be granted.
ESIC issues Corrigendum on Not of Standard Quality drug batch of item No. 1962
The stakeholders are now informed that a Corrigendum has been received from Central Drugs Laboratory Kolkata in respect of the Batch No. of the item declared NSQ on 22.12.2022. In the notice dated 27th January, 2023 the batch number of the concerned NSQ drug was mentioned as TTQ2P5, however the batch number is TTQ2P3.
Guidelines for International Arrivals in supersession of guidelines issued on the subject on 29th December 2022
All travellers should preferably be fully vaccinated as per the approved primary schedule of vaccination against COVID 19 in their Country. Any passenger having symptoms of COVID-19 during travel shall be isolated as per standard protocol i.e. the said passenger should be wearing mask, isolated and segregated from other passengers in flight/travel and shifted to an isolation facility subsequently for follow up treatment.
Traders and hospitals in Kerala are ordered to return the drugs found to be sub-standard in quality check
Traders and hospitals holding stock of these drugs should return them to the supplier and inform the district drug control authorities concerned about the details.
Govt. of Kerala mandates Registration of Infertility Clinics
The notification states that registration is mandatory for private/government institutions to provide infertility treatment. Those institutions providing reproductive infertility services should take steps for immediate registration of their institutions. All relevant institutions shall get themselves registered through the National ART and Surrogacy Portal. The prescribed registration fee would be payable to the specified account in the name of the Appointed Authority.
Implementation of NIC Aadhar Enabled Biometric Attendance System (AEBAS), HMIS and connecting CCTV feed to NMC
The NMC has observed that despite various reminders and requests, many medical colleges are yet to fully implement these IT initiatives. AII colleges are therefore, again directed to take necessary steps to fully implement Aadhaar Enabled Biometric Attendance System (AEBAS), Hospital Management Information System (HMIS) and connection of CCTVs feed to Command & Control Centre at National Medical Commission immediately in order to prevent adverse actions against them.
NMC notifies the Enrollment of Medical Colleges as Adverse Drug Reactions (ADR) Monitoring Centers under PvPI
The National Medical Commission (NMC) has issued a public notice directing all medical colleges/ hospitals under the NMC to get themselves enrolled with the with Indian Pharmacopoeia Commission (IPC) as Adverse Drug Monitoring Centres (AMCs). This direction was issued on 25th January, 2023 and must be complied with at the earliest.
Extension of commencement of requirement for a Health Certificate for the import of Milk & Milk products, Fish & Fish products, and Pork & Pork Products
FSSAI order regarding the requirement of a Health Certificate for the import of Milk & Milk products, Fish & Fish products, and Pork & Pork Products order will now be effective from March 01, 2023.
CDSCO notifies inspections/ audits of pharmacovigilance (PV) of importers and manufacturers of human vaccine.
The New Drugs and Clinical Trial Rules, 2019 state that the importer of manufacturer of any new drug for sale and distribution shall have a PV system. The system shall include a place for collecting, processing and forwarding the Adverse Drug Reaction (ADR) reports to the central licensing authority. This information will emerge from the use of the new imported/ manufactured/ marketed drug by the applicant in India.
