New Delhi, India: Zydus Cadila, a pharmaceutical company, announced on Tuesday that it has gotten conditional approval from the US Food and Drug Administration to market Lenalidomide Capsules, which are used to treat certain types of malignancies.

The US Food and Drug Administration (USFDA) has given the company provisional approval to market Lenalidomide Capsules in the strengths of 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg.

Lenalidomide is used to treat various types of cancers. It works by slowing or stopping the growth of cancer cells. It is also used to treat anemia in patients with certain blood/bone marrow disorders (myelodysplastic syndromes-MDS).

The drug will be manufactured at the group’s formulation manufacturing facility at the SEZ, Ahmedabad, the company said in a statement.

The National Pharmaceutical Pricing Authority (NPPA) has capped the trade margin of 42 selected non-scheduled anti-cancer medicines under the ‘Trade Margin Rationalisation (TMR)’ Approach, resulting in a reduction of up to 90% of the Maximum Retail Price (MRP) of 526 brands of these medicines, Mansukh Mandaviya, Union Health Minister, announced yesterday in Lok Sabha.

The National Pharmaceuticals Pricing Policy (NPPP), 2012, prescribes the guidelines for the regulation of the prices of drugs. The key principles of price regulation are the essentiality of drugs, control of prices of formulations and market-based pricing.

NPPA has fixed the ceiling prices of scheduled drugs, including the essential medicines used for the treatment of cancer, diabetes and HIV as well as heart and kidney diseases, Mandaviya added.

He further said that NPPA has also brought 106 non-scheduled anti-diabetic and cardiovascular drugs under price control by invoking extraordinary powers in public interest. The total annual savings on account of revision of ceiling prices of medicines under the National List of Essential Medicines (NLEM), price control of anti-diabetic and cardiovascular, fixation of ceiling price of stents, knee implants and capping of TMR on anti-cancer are estimated to the tune of Rs 12,500 crores.

NPPA monitors the ceiling price of the scheduled formulations to ensure that the MRP of such formulations is within the range of the ceiling price, and monitors non-scheduled formulations to ensure that their MRP does not increase by more than 10 per cent during the preceding twelve months, he mentioned.

medicines

The USFDA has given Zydus Cadila preliminary approval to market the cancer medication ‘Lenalidomide’

The NPPA limits the trade margin of 42 non-scheduled anti-cancer medications