MDC recommends exemption for Cadila Pharma’s Vitamin D3 injection from price control
The Multi Disciplinary Committee (MDC) of Experts of the National Pharmaceutical Pricing Authority (NPPA) has recommended exemption of Cadila Pharmaceuticals’ dietary supplement Vitamin D3 Injection (cholecalciferol aqueous injection 6,00,000 IU/2ml) from the drug price control for certain period as it is covered under the scope of patent granted by the Patent Office.
The company on May 8, 2023 had applied for exemption of Cholecalciferol aqueous injection 6,00,000 IU/2ml from the Drugs (Prices Control) Order (DPCO), 2013, under the Para 32 (i) and (ii) of the Order, along with a copy of the patent issued on May 4, 2023 under the Patent Act, 1970.
Under Para 32 (i), the provisions of DPCO shall not apply to a manufacturer producing a new drug patented under the Indian Patent Act (product patent) and not produced elsewhere, if developed through indigenous research and development, for a period of five years from the date of commencement of its commercial production in the country.
Under Para 32 (ii), the provisions of DPCO shall not apply if a manufacturer produces a new drug in the country by a new process developed through indigenous research and development and has a process patent, for a period of five years from the date of the commencement of its commercial production in the country.
The Committee observed that while cholecalciferol is listed in Section 26.4 of Schedule I of DPCO, 2013 as Solid Oral Dosage Form 1000 IU, 60,000 IU and Oral Liquid 400 IU/ml and the company has applied for exemption of aqueous injection.
It noted that NPPA had earlier not fixed the retail price of Vitamin D3 Injection and one application received for the same was rejected due to non-submission of approval from the Drugs Controller General (India).
It observed that Cadila Pharma has submitted the patent certificate valid for a period of 20 years from February 3, 2018 for “An aqueous parenteral composition of Vitamin D 3”.
It has also submitted CDSCO permission dated April 17, 2023, for the formulation and filed a declaration that it does not have proposal to discontinue or reduce production of the scheduled formulation.l
The company also submitted production and sales data of the scheduled formulation for last six quarters duly certified and submitted a declaration that the applied formulation is not prohibited by the drug regulator or the Ministry of Health and Family Welfare (MoHFW).
The Patent office also through a letter in August, this year, informed the Committee that the said formulation and the process through which it is developed are covered under the scope of patent granted by the Office.
“Vitamin D3 is otherwise known as Cholecalciferol and the composition comprising the same as granted is 3,00,000 to 6,00,000 IU/ml of Vitamin D3 or 600,000 IU/2ml if the lower side range is considered,” it said.
The Committee also noted the company’s submission with respect to the need, benefits, and superiority of an aqueous parenteral composition of Vitamin D3, including that it is world’s first water-based injection, and the company strongly believes that only the new water-based injection demonstrates significantly enhanced efficacy over the oil-based injections.
The company also claimed that compared to conventional formulation, the aqueous formulation rapidly increases the level of serum 25 (OH)D within one hour. Oil containing injectable formulation can cause pain, erythema, swelling nodule formation at the site of injection and they have to be injected deep intramuscularly, it added.
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