Cadila's Cholecalciferol Aqueous Injection 6,00,000 IU/2ml exempted from price control: NPPA

This came in line with the application presented by Cadila Pharmaceuticals for exemption from the provisions of Drug Price Control Order 2013 under Para 32 (i) to (ii) for the formulations “cholecalciferol Aqueous Injection 6,00,000 IU/2ml (Vitamin D3 Injection)”

Cholecalciferol (vitamin D3) is in a class of medications called vitamin D analogs. Cholecalciferol is needed by the body for healthy bones, muscles, and nerves, and to support the immune system. It works by helping the body to use more of the calcium found in foods or supplements.

At the 117th meeting of authority under DPCO, 2013 held on 13.10.2023, the authority noted that the formulation "Cholecalciferol Aqueous Injection 6,00,000 IU/2ml (Vitamin D3 Injection)" of Cadila Pharmaceuticals meets the requirement of Para 32(i) and 32(ii) of DPCO 2013.

The Para 32(i) &32(ii) of Drug Price Control Order 2013 (DPCO 2013) stated:

The provisions of drug price control order shall not apply to, -

(i) a manufacturer producing a new drug patented under the Indian Patent Act, 1970 (39 of 1970) (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.

(ii) a manufacturer producing a new drug in the country by a new process developed through indigenous Research and Development and patented under the Indian Patent Act, 1970 (39 of 1970) (process patent) for a period of five years from the date of the commencement of its commercial production in the country.

In reference to the above, the authority highlighted that Cadila Pharmaceutical's “Cholecalciferol Aqueous Injection 6,00,000 IU/2ml (Vitamin D3 Injection)” was duly approved by the Office of Central Drugs Standard Control Organisation (India) as a ‘new drug’ under the Drugs and Cosmetics Act, 1940 and Rules thereunder.

Furthermore, the authority found that the Patent Office, Government of India has granted a Patent to Cadila Pharmaceuticals for an invention entitled “AN AQUEOUS PARENTERAL COMPOSITION OF VITAMIN D3” for the term of 20 years from 3rd February 2018 in accordance with the provisions of the Patents Act, 1970(Patent No. 431119 and Date of Grant: 04.05.2023).

In view of the above, the authority decided that exemption may be granted to Cadila Pharmaceuticals under Para 32(i) and 32 (ii) of DPCO, 2013 for their formulation “Cholecalciferol Aqueous Injection 6,00,000 IU/2ml (Vitamin D3 Injection)”.

In light of the above, the notice stated:

"In the exercise of the powers delegated under para 32 of the Drugs (Prices Control) Order, 2013 vide S.O. 1394(E) dated 30th May 2013 issued by the Government of India in the Ministry of Chemicals and Fertilizers, Cadila Pharmaceuticals Limited is exempted from the provisions of DPCO, 2013 under para 32(i) & 32 (ii) of the said order in respect of the formulation “Cholecalciferol Aqueous Injection 6,00,000 IU/2ml (Vitamin D3 Injection)” for a period of five years from the date of commencement of its commercial marketing by the manufacturer in the country or expiry of the Indian patent, whichever may be earlier."

In addition, the Authority further suggested, " Cadila Pharmaceuticals Limited shall inform NPPA, the date of commercial marketing of the formulation “Cholecalciferol Aqueous Injection 6,00,000 IU/2ml (Vitamin D3 Injection)” in the country and the Price to Retailer (PTR) and Maximum Retail Price fixed by the company in respect of above said formulation by issuing a price list in Form V under DPCO, 2013."

Furthermore, the committee stated, "Cadila Pharmaceuticals shall also seek retail price approval for the formulation “Cholecalciferol Aqueous Injection 6,00,000 IU/2ml (Vitamin D3 Injection)”, if applicable, three months before the expiry of the exemption granted under Para 32(i)& 32 (ii) of DPCO 2013."

To view the official notice, click the link below:

https://medicaldialogues.in/pdf_upload/cadila-engl-224065.pdf