Category: Healthcare Industry Updates

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.

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"

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.

With effect from the date as may be specified by Central Government, a medical device, approved for manufacture for sale or distribution or import, shall bear unique device identification in the manner as may be …

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

Institutions of medical education who were not able to get permission to start new medical colleges, courses or increase the number of seats for MBBS, MD, MCH can apply again for the year 2022-2023.

However, cases under categories such as homicide, suicide, rape, decomposed bodies and suspected foul play should not be subjected for post mortem during night time unless there is a law and order situation. Post-mortem for …

Read More "Clarification regarding Conduct of Post mortem in Hospitals after sunset"

The scheme will provide financial incentives on the incremental sales (over Base Year) of pharmaceutical goods and in-vitro diagnostic medical devices to selected applicants based on pre-defined selection criteria. The incentives will be paid for …

Read More "Ministry of Chemical and Fertilizers notifies the Production Linked Incentive (PLI) scheme for the Pharmaceutical Sector."