Last Updated on July 21, 2021 by The Health Master
The Department of Pharmaceuticals (DoP) is in the process of compiling and publishing a list of Frequently Asked Questions (FAQs) based on queries raised or clarifications sought by the industry in connection with the production linked incentive (PLI) scheme for pharmaceuticals. The department has 17 Foreign Direct Investment (FDI) proposals pending for disposal, as it has not disposed any of the proposals in June.
In the Monthly Summary Report of DoP for the month of June, 2021, the department said that the operational guidelines of the PLI scheme for pharmaceuticals was issued on June 1, 2021 and multiple rounds of outreach sessions have been held with the concerned stakeholders including States, Union Territories, industry associations as well as companies for wide dissemination as well as providing clarifications.
Based on industry feedback, the selection criteria have also been suitably modified to provide a level-playing field for API manufacturers vis-a-vis formulation manufacturers.
“The Department is also in process of compiling and publishing a list of FAQs based on queries raised/clarifications sought by the industry,” it said. It has 17 FDI proposals pending including six received during the month and 11 pending at the beginning of the month.
Three meetings of the Drugs Coordination Committee were held during the month, which recommended allowing restricted exports of remdesivir in a phased manner; building a buffer of essential C-19 drugs, systematic monitoring of availability and supply of conventional amphoterici-B; prioritising imports by the end of June, 2021; discontinuation of allocation of conventional amphotericin-B in view of sluggish demand from States/Union Territories.
A Department-vide Office Memorandum dated June 30, 2021 to ministry of health and family welfare has shared a list of medical devices used in management of C-19 under Red, Yellow and Green categories based on the lead time of their supply to enable advance planning for building adequate inventory, as part of preparedness to meet any surge in demand in future.
The National Pharmaceutical Pricing Authority (NPPA) has fixed retail prices of 15 new medicines during the month, bringing cumulative figure to 1,548 till June 2021.
During the month, NPPA has also capped the trade margin at 70 per cent on price to distributors level with respect to oxygen concentrators. The revised maximum retail price for the oxygen concentrators with effect from June 9, 2021 was published through an Office Memorandum.
The C-19 control room set up by NPPA received 1,139 complaints during the second wave of the pandemic upto June, related to the availability of medicines. It is also monitoring supplies of amphotericin and tocilizumab on a daily basis. Against an allocation of 10.01 lakh vials of amphotericin till June 30, 2021, by the department, supply to the tune of 8.12 lakh vials was made to the State and Union Territory governments. Similarly, supply of 93.85 lakh vials of remdesivir was made against an allocation of 9.87 lakh vials.
The pricing regulator has received a total overcharged amount of Rs. 9.96 crore during the month.
In the month of June, the department has completed setting up of 19th Price Monitoring and Resource Units (PMRUs), by setting up a PMRU in the State of Jharkhand. The department is actively following up with the rest of the States and Union Territories for setting up of the PMRUs.
It has also opened 102 Jan Aushadhi Kendras under Pradhan Mantri Bhartiya Janaushadhi Pariyojana during the month, taking the cumulative total to 7,867 Kendras.
The National Institutes of Pharmaceutical Education and Research (NIPERs) published 46 papers in June, taking the total to 146. Out of seven patents filed during the current financial year, two patents has been filed during the month.
The C-19 Drug Management Cell in the department continued allocation and monitoring supply of tocilizumab and amphotercin-B to States and Union Territories and Central Government Hospitals for equitable distribution. The allocation of remdesivir was last done in May, 2021 with a total quantity of 98.87 lakh vials being allocated to States and UTs.
The exports of remdesivir are being allowed in a calibrated manner while also ensuring the procurement by HLL for buffer stock is given priority. The department said that close coordination is being maintained by ministry of external affairs and domestic manufacturers to ensure supply side constraints are resolved.