The list of 11 formulations includes Bedaquiline, Bendamustinehydrochloride, Buprenorphine, Buprenorphine (A) plusNaloxone (B), Daclatasvir, Delamanid, Irinotecan HCltrihydrate, Phenoxymethyl penicillin, ProcaineBenzylpenicillin, TenofovirDisproxilFumarate(A) plus Lamivudine(B)+Dolutegravir(c), Valganciclovir.
Earlier, the Medical Dialogue Team had reported the upgradation of the National List of Essential Medicines (NLEM) 2022, comprising 384 drugs across 27 therapeutic categories.
In accordance with the revised National List of Essential Medicines, the 34 new medicines were added to the list which includes Amikacin, Bedaquiline, Bendamustine Hydrochloride, Buprenorphine, Buprenorphine (A) plus Naloxone (B), Cefuroxime, Dabigatran, Daclatasvir, Darunavir (A) plus Ritonavir (B), Delamanid, Dolutegravir, Fludrocortisone, Insulin Glargine, Irinotecan HCI Trihydrate, Itraconazole, Ivermectin, Lamivudine, Latanoprost, Lenalidomide, Leuprolide acetate, Meropenem, Montelukast, Mupirocin, Nicotine replacement therapy (NRT), Ormeloxifene (Centchroman), Phenoxymethyl penicillin,Procaine Benzyl penicillin, Rotavirus vaccine, Tenecteplase,Teneligliptin, Tenofovir (A) + Lamivudine (B) + Dolutegravir (C), Tenofovir Alafenamide Fumarate (TAF), Terbinafine, Valganciclovir.
Recently, with reference to the fixation of ceiling prices for scheduled formulations under Revised Schedule I (NLEM 2022) of DPCO 2013, the NPPA asked all the concerned manufacturers / marketing companies to furnish the Price to Retailer (PTR) and Moving Annual Turnover (MAT) in value terms for the month of July, 2022 in the format mentioned given in Table 1.
Table 1
S.No. | Formulation | Brand | Composition & Strength | Dosage/Specification | Price to Retailer (PTR) for July, 2022 | MAT* Sales Value as on July, 2022 (Rs.) |
Type | Size |
1. | | | | | | | |
2. | | | | | | | |
3. | | | | | | | |
4. | | | | | | | |
"*Moving Annual Turnover (MAT) Sales (excluding taxes) for July 2022 means total sales during August 2021 to July 2022." it is added.
Furthermore, the office memorandum added, "The information may be furnished positively within 7 days from the Issue of this O.M. in respect of formulations mentioned in Table 2 below for taking appropriate action for fixation of ceiling prices pursuant to the issue of Revised Schedule-I of DPCO, 2013."
Table 2
S.N. | NLEM, 2022 Section No. | Medicine | Dosage form(s) and strength(s) |
1 | 6.4.2 | Bedaquiline | Tablet100mg |
2 | 7.1.6 | Bendamustinehydrochlorid e | Injection 25 mg/ vial |
3 | 23.5.1 | Buprenorphine | Tablet(Sub-lingual)0.4mg |
4 | 23.5.2 | Buprenorphine (A) +Naloxone (B) | Tablet(Sub-lingual)0.4mg(A)+0.1mg(B) |
5 | 23.5.2 | Buprenorphine (A) +Naloxone (B) | Tablet(Sub-lingual)2mg(A)+0.5mg(B) |
6 | 6.8.1 | Daclatasvir | Tablet30mg |
7 | 6.4.6 | Delamanid | Tablet50mg |
8 | 7.1.26 | Irinotecan HCltrihydrate | Solutionforinjection20mg/mL |
9 | 6.2.2.11 | Phenoxymethyl penicillin | Tablet250mg |
10 | 6.2.2.12 | ProcaineBenzylpenicillin | Powder for injection1000mg(=1millionIU) |
11 | 6.7.1.6 | TenofovirDisproxilFumarate (A) +Lamivudine(B)+Dolutegra vir(c) | Tablet300mg(A)+300mg(B)+50 mg(c) |
12 | 6.6.2.1 | Valganciclovir* | Powder for oral solution 50mg / mL |
"The above-mentioned information may be furnished within the stipulated period so that the ceiling prices are fixed in a transparent manner." the O.M further added.
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