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NPPA approves 157 intimations for discontinuation of scheduled formulations from April 2020 to July 2023
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Gireesh Babu, New Delhi
August 11 , 2023
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The National Pharmaceutical Pricing Authority (NPPA) has received a total of 226 intimations under Form IV for discontinuation of scheduled formulations from the market between April 1, 2020 and July 31, 2023 and has approved 157 cases.
According to the data from the NPPA, it has approved 27 Form IV intimations in 2022-23 with directions to most of the applications to continue production till certain months of the year 2023, as compared to 48 approved in 2021-22 and 36 in 2020-21. In 2021-22, the 36 Form IV filed included an application for discontinuation of a total of 81 compositions.
In the last three financial years, Para 3 has been invoked for ensuring continued production of the drugs in four cases wherein Form IV was filed.
The ministry of chemicals and fertilisers, under which the NPPA operates, has said in the Lok Sabha on August 4 that to ensure the availability of scheduled drugs, Paragraph 21(2) of the Drugs Price Control Order (DPCO) 2013 provides that any manufacturer intending to discontinue any scheduled formulation from market shall intimate the Government in Form IV of Schedule-II of DPCO, 2013 in this regard, at least six months prior to the intended date of discontinuation.
"NPPA received 226 intimations under Form IV during FY 2020-21 to FY 23- 24 (till 31st July 2023) and approved 157 Form IV cases over the same period and invoked Para 3 for invoking continued production of the drug. The Form IV intimation are approved only in cases where the market share is not significant and there are sufficient number of other players in the market," said minister of state in the ministry of chemicals and fertilisers Bhagwanth Khuba.
Further, in case, it is considered necessary in public interest to extend the period of continued production beyond one year from the intended date of such discontinuation, the government may do so under Para 3 of DPCO, 2013 and direct the manufacturer to increase/maintain the production level of the medicine.
No complaints of non-availability of scheduled drugs due to discontinuation has been received in the last two financial years, he added while answering a question.
According to the data from NPPA, the Authority has approved requests from various companies, and a major part of these approvals were to Baxter Pharmaceuticals India Pvt Ltd, during the year 2022-23.
The Authority has approved 10 requests from Baxter, filed in October, 2022 for discontinuation of products including Sedoz 1mg injection (midazolam injection 1mg/ml) in a couple of pack sizes, Sucrofer 20mg injection (iron sucrose injection 20 mg/ml) in a couple of pack sizes, Zepita (piperacillin & tazobactam injection IP, 2.25 gm) and Zepita 4000/500 (piperacillin & tazobactam injection IP 4.5 gm), Panisa (pantoprazole for injection 40 mg), and Profol 10 mg (propofol injection IP 10 mg/ml in 10 ml, 20ml and 50 ml packs).
The decision followed company's request that it is financially unviable to sustain production and due to continued financial losses in the Indian operations due to high cost.
Six applications from Kedrion Biopharma India Private Limited, New Delhi including for hepatitis B immunoglobulin, human plasma coagulation factors, human tetanus immunoglobulin and others were approved since the stakeholders of the company decided to discontinue the business in India. These drugs will be produced or imported to the country till October 5, 2023, says the data.
Five applications from Gujarat-based Unison Pharmaceuticals for its levofloxacin and ondansetron formulations were also considered as the company said that it has a low market share and there is a lack of demand in the market.
Three applications from Indoco Remedies Ltd, Mumbai for Clamchek 625 tablets (amoxicillin 500mg and clavulanic acid 125 mg), AXL 500 mg capsules (amoxycillin 500mg), and OH-D3 capsules (vitamin D3 - cholecalciferol - 60000 IU) owing to decreasing sales and low value were also approved by the Authority.
Two Form IV intimations from Neon Laboratories Ltd for erythropoietin injection and timolol maleate eye drops were also considered due to insignificant market share for these brands.
It has also approved an intimation from Pfizer Products India for Cyklokapron 100 mg (tranexamic acid solution 100mg/ml) as the company informed that it has insignificant market share for the product.
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