ICMR issues an Advisory on Strategy for COVID-19 Testing in India
The advisory caters to screening of COVID-19 in three settings: in containment zones or points of entry, in non-containment areas and in hospitals. It stipulates the choice of test (Rapid Antigen Testing or RT-PCR/ TrueNat/ CBNAAT) in the order of priority in each setting. For example, in containment zones and points of entry, the order is RAT first and then RT-PCR/ TrueNat/ CBNAAT. The advisory also lists the different cases where there must be mandatory testing in each of the settings.
CDSCO notifies online system for applying for free sale certificate for medical devices.
The Certificate is applicable to those medical device manufacturers in India who are having valid manufacturing license and intent to obtain Free Sale Certificate for export of Class A, B and Class C, D medical devices.
Guidelines for use of Remdesivir injunctions
The hospitals which use Remdesivir drug shall record the batch number and the daily dose administered in the patient case sheet which shall be duly attested by the treating physician. The stock details of the drug shall be recorded in the exclusive stock register. The Vial of the drug shall be preserved for inspection.
MoHFW extends timeline for CS (MA) beneficiaries to procure medicines for chronic diseases from local pharmacies on existing prescriptions till 30.09.2020
To reinforce guidelines on social distancing, the government had previously elucidated that CS (MA) beneficiaries who required medicines for chronic diseases could purchase them from their local pharmacies. Such purchases should be based on prescriptions already held by the beneficiaries and issued by Authorised Medical Attendants. The Government has now extended the deadline for making such purchases to 30th September 2020. Moreover, the concerned Ministry/ Department/ Organisation will continue processing medical claims for reimbursement, submitted by the beneficiaries.
MoHFW has advised COVID-19 Screening for all TB Patients and vice versa
The Guidance Note contemplates COVID screening for diagnosed TB patient and TB screening for COVID positive patients. Additionally, the Note requires the establishment of linkages of TB service facilities with COVID Isolation facilities. Additionally, The Guidance Note also specifies the eligibilty criteria and the Diagnostic Algorithm for TB screening for ILI and SARS cases.
The Central Government adds to the lists of controlled substances through the NDPS (Regulation of Controlled Substances) Amendment Order 2020
The Amendment includes two more substances into the list of Schedule A Substances. These are substances whose manufacture distribution, sale, purchase, possession, storage and consumption are in accordance with the Narcotic Drugs and Psychotropic Substances (NDPS) Order, 2013. It also adds 4 substances to both, Schedule B and Schedule C. These Schedules cover substances whose export and import, respectively, are subject to the NDPS Order, 2013.
MoHFW issues Clinical Guidance on Diabetes Management at COVID-19 Patient Management Facility
The Guidance Note at the very outset states that every patient, at the time of admission, must be screened for hyperglycemia by a glucometer, with at least two capillary blood glucose values. Secondly, every patient with diabetes must be started on diabetic diet which must be strictly adhered to in terms of quantity and timing. Furthermore the Guidance Notes deals in detail with the management of diabetic treatment, including directions concerning use of Oral Antihyperglycemic Drugs, initiation of Basal-bolus insulin regimen, use of intravenous insulin infusion, among others.
NPPA streamlines procedures for application submissions to promote Ease of Doing Business
Forms I and Applications for special price for packaging under the Drugs (Price Control) Orders, 2013 can now be submitted online through email to a specified email ID. The notification stipulates for a confirmatory email and a means to check the status of these applications on the NPPA website. However submissions of Forms-II/ Forms-III and Forms-V will follow the existing procedure of submission on the Integrated Pharmaceutical Database Management Systems (IPDMS). On the other hand, Form-V will now be submitted online as well through email to a specified email ID. Furthermore, all pharmaceutical associations are required to upload the Uniform Code of Pharmaceutical Marketing Practices on their websites. The notification provides details that must be included in this regard.
NPPA fixes retail prices for 29 formulations
The prices fixed for each unit of the formulation are based on the strength of the formulation. Further, these prices are fixed for specified manufacturers & marketing companies. The retail price for a pack of these formulations will be determined by the manufacturers based on the retail price fixed for the unit of the formulation. Manufacturers are required to issue a price list in Form–V to NPPA as per the provisions of DPCO, 2013. If retail prices fixed by this Order for any of the specified formulations are not complied with, the concerned manufacturer/marketing company will be liable to deposit the overcharged amount along with the interest thereon.
MoHFW issues guidelines on safe Ophthalmology Practices.
These guidelines are aimed to minimize the spread of Covid-19 infection among ophthalmologists, Ophthalmic assistants/technicians, nurses, support staff, patients and their attendants,
