MoHFW appoints 25th January 2022 as the date on which the provisions of Surrogacy (Regulation) ACT , 2021 shall come into force.
The Act prohibits commercial surrogacy and allows only altruistic surrogacy which involves no monetary compensation to the surrogate mother other than the medical expenses and insurance coverage during pregnancy.
New Drugs and Clinical Trials (2nd Amendment) Rules, 2022
The authority designated by the Central Government in the Ministry of Health and Family Welfare, Department of Health Research under these rules shall act an registration authority under the act for the purpose of registration of ethics committee related to biomedical and health research.
Drugs (2nd Amendment) Rules, 2022
Liquid Antiseptics for household use is exempted from requirement of sale license in Form 20 or Form 20A.
The Drugs (Amendment) Rules, 2022.
As per the amendment under rule 96(5) every active pharmaceutical ingredient (bulk drug) manufactured or imported in India shall bear Quick Response code on its label at each level packaging that store data or information readable with software application to facilitate tracking and tracing.
The Medical Devices (Draft Amendment) Rules, 2021.
If the manufacturer or licensee fails to comply with any of the conditions of an import license, or any provisions of the Act and these rules, the Central Licensing Authority may after giving the manufacturer or licensee an opportunity to show cause why such an order should not be passed, by an order in writing stating the reasons therefor, cancel a license issued under rules, or suspend it for such period as it thinks fit either wholly or in respect of any of the part of medical device to which it relates.
Medical Devices (Amendment) Rules, 2022
The amendment provides that a provisional registration number shall be generated which will remain valid up to the 31st May, 2022 if the applicant submits, on or before the 28th February, 2022, an undertaking that applicant shall obtain the ISO 13485 certificate on or before the 31st May, 2022 in lieu of certificate of compliance
Government of Goa to auto renew DDSSY card with blanket cover from 1st April 2022 to 31st March 2023.
The DDSSY policy provides Universal Health Cover through Insurance for the Entire Resident Population of Goa. Benefits under this scheme will be provided on a cashless basis to the Beneficiaries upto the limit of their annual coverage.
New Drugs and Clinical Trials (Amendment) Rules, 2022
The amendment has extended the scope of new drugs to include cell or stem cell derived product. Previously the definition of new drug under the New Drugs and Clinical Trials Rules only included stem cell derived product.
MoHFW publishes revised guidelines for managing Health Care Workers (HCWs) working in COVID and Non COVID areas of the Health Care Facilities.
All the Healthcare workers must report every unprotected exposure/ breach of PPE while managing COVID-19 patients to the concerned nodal officer and HoD of the concerned department immediately. Such exposed HCWs shall continue to work wearing appropriate PPE and test themselves at day 5 of the exposure or if symptoms develop anytime within 14 days from the day of exposure.
PCI Introduces late fee in respect of institutions which have failed to apply on PCI portal during approval process 2022-2023.
The Institutions which have forgotten the user ID& Password are required to submit the duly notarized affidavit on 100 rupees court paper in the prescribed format so as to reach the council’s office on or before 12th January 2022 and the affidavit submitted after 12th January 2022 will not be entertained by the PCI.
