Invoking Paragraph 3 of the Drugs (Prices Control) Order, 2013, the National Pharmaceutical Pricing Authority (NPPA) has ordered Mumbai-based Macleods Pharmaceuticals to provide the Central Medical Services Society (CMSS) with 150 mg and 450 mg of the anti-tuberculosis medication rifampicin in capsule form. Rifampicin, sold under the brand name Macox, is produced by Macleods and is used either alone or in conjunction with other medications to treat different types of tuberculosis.
After discussing the issue at a recent meeting, the NPPA opted to use Paragraph 3 of the DPCO, 2013 to guarantee that CMSS, New Delhi, would receive the medication at the stated or relevant ceiling rates. According to paragraph 3 of the DPCO, 2013, the government has the power to order formulators to sell their formulations to organizations, hospitals, or other agencies, or to increase production and sell the product to other manufacturers from any manufacturer of bulk drugs, formulations, or active pharmaceutical ingredients (API). The purpose of this directive is to control the distribution of medications and guarantee their sufficient availability in case of emergency, urgent situation, or for non-commercial usage in the public interest.
Prior to this, Macleods and other businesses asked that different bidding clauses be changed in CMSS tenders for first-line anti-TB medications for the National Tuberculosis Elimination Programme. These requests included modifying the terms under which CMSS is permitted to reserve the right to make repeat orders for up to 50% of the tendered quantity during a 12-month period and to increase or decrease the quantity of drugs purchased by up to 25%. Since raw materials are booked against advance payments in a volatile market, Macleods and others contended that the provision for a drop in quantities should be deleted because of the effect on costing. Additionally, they recommended eliminating the repeat order provision because the tender’s indicated numbers serve as the basis for costing.
Companies asked for partial payment during a September 2022 Pre-Bid conference with CMSS and NTEP after supplying 10% of an order, given that standard quality reports from authorized CMSS laboratories were received. Their operating capital is strained, they claimed, by the vast quantities needed and the present strategy of only releasing payment once half of the goods are delivered. Nevertheless, at the meeting, the terms remained unchanged as a result of these requests.
In four instances when Form IV for the cessation of planned formulations was filed, the government invoked Paragraph 3 of the DPCO, 2013, according to information provided to the Lok Sabha on August 4, 2023, by Bhagwanth Khuba, the Minister of State in the Ministry of Chemicals and Fertilizers at the time. To guarantee the ongoing production of drugs, this was done. Manufacturers who want to stop producing any scheduled formulation must notify the government using Form IV of Schedule-II at least six months in advance of the planned cessation date, per paragraph 21(2) of the DPCO, 2013.
The NPPA authorized 157 of the 226 Form IV notifications it received between the fiscal years 2020–21 and 2023–24 (up to July 31, 2023), using Paragraph 3 to guarantee the continuation of drug manufacture. Only when there were enough substitute suppliers and the market share was negligible were approvals given. In answer to a question from the Lok Sabha, Khuba gave this information, demonstrating the government’s dedication to preserving the supply of necessary medications.
SOURCE:
PHARMABIZ.COM
