Category: Healthcare Industry

The Assisted Reproductive Technology (Regulation) Act, 2021 is for regulating and supervising the assisted reproductive technology clinics and the assisted reproductive technology banks, and prevention of misuse.

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.

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 …

Read More "New Drugs and Clinical Trials (2nd Amendment) Rules, 2022"

Liquid Antiseptics for household use is exempted from requirement of sale license in Form 20 or Form 20A.

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 …

Read More "The Drugs (Amendment) Rules, 2022."

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 …

Read More "The Medical Devices (Draft Amendment) Rules, 2021."

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 …

Read More "Medical Devices (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 …

Read More "New Drugs and Clinical Trials (Amendment) Rules, 2022"

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 …

Read More "MoHFW publishes revised guidelines for managing Health Care Workers (HCWs) working in COVID and Non COVID areas of the Health Care Facilities."

Liquid Medical Oxygen is high purity oxygen, which is used for medical treatment. Telemetry devices are installed in these liquid medical oxygen tanks so that it can be monitored in real-time. The telemetry device will …

Read More "Peso issues circular on installation of telemetry devices on Liquid Medical Oxygen Storage Vessels."