NPPA extends capping of trade margin on oxygen concentrators till 30th June 2022.

NPPA in its earlier notification, capped the price of oxygen concentrator through trade margin rationalisation approach at first point of sale of product, referred as Price to Distributor, as per a prescribed formula by invoking Paragraph 19 of Drugs Prices Control Order (DPCO) – 2013 in wake of increase in demand due to pandemic.

NHA launches an online public dashboard for Ayushman Bharat Digital Mission (ABDM).

For Health Facility Registry, the dashboard presents the data in infographics format based on ownership (government or private), systems of medicine (Modern Medicine – Allopathy, Ayurveda, Sowa- Rigpa, Physiotherapy, Unani, Dentistry, Siddha, Homeopathy etc.) and state-wise facilities registered under the ABDM. Similarly, for the HPR, the dashboard shows the data segregation on basis of their employment type – government or private sector, systems of medicine and the states/ UT from where the applications have been received.

The government of Goa notifies fees for units handling bio-medical waste.

The central monitoring committee was set up to review the implementation of the Bio-medical Waste Management (BMWM) Rules, 2016 and it decided that the issue of charging of registration fee is a state-specific issue and comes under the purview of State Pollution Control Boards/Pollution Control Committee.

Drugs (Amendment) Rules, 2022.

The amendment provides that Liquid Antiseptics for household use that are not purchased from a licensed wholesaler or a licensed manufacturer are also exempted form requirement for a sale license in Form 20 or Form 20A.

MoHFW enlists drugs that can be sold Over-The-Counter (OTC) by retail

Sale by retail Over-The-Counter without prescription of a Registered Medical Practitioner (RMP) shall be subject to the following conditions, namely:—
(a) The maximum duration of treatment/use should not exceed five days.
(b) If the symptoms do not resolve the patient should consult Registered Medical Practitioner.
(c) Pack size may not exceed the maximum doses recommended for five days.
(d) Each pack of the drug may be accompanied with Patient Information Leaflet (PIL).
(e) The indication claimed should be same as already approved by the Licensing Authority.

Draft Drugs (Amendment) Rules, 2022

Where an application is made for the manufacture of drug formulation falling under the purview of New Drug as per the New Drugs and Clinical Trials Rules, 2019 or Drugs Rules, 1945, as the case may be, the license to manufacture for sale or distribution of the drugs shall be granted after approval of the drug as new drug.

Medical Devices (Third Amendment) Rules, 2022

The amendment provides that if the manufacturer or licensee importing medical devices 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.

CDSCO extends consent to import drugs with less than 60% till 31st October 2022.

According to the provisions of Rule 31 of the Drugs and Cosmetics Rules, 1945, no drug will be imported unless it complies with the standard of strength, purity, and quality when the drug licensing authority will not allow the import of a drug with a less than 60 percent residual shelf life on the date of import of the drug.