Pharmaceutical pricing authority discussed issue in 2019, show documents

The shortage of key leprosy drug clofazimine in the country is not of recent origin, but a long-standing problem not properly addressed by the Union government, official documents show.

Minutes of a meeting of the National Pharmaceutical Pricing Authority (NPPA) under the Drug Pricing Control Order (DPCO), 2013 dated October 30, 2019 say Abbott Healthcare Private Limited has been directed not to discontinue the production of the drug as it could lead to shortages. DPCO is an order under the Essential Commodities Act, 1955 that enables the Union government to control and fix the prices of essential medicines and their formulations.

The meeting discussed the Form-IV submitted by the company for the discontinuation of scheduled drug formulations Hansepran 50 mg (Clofazimine Capsule 50mg) and Hansepran 100 mg (Clofazimine Capsule 100mg) under para 21(2) of DPCO.

“[The] authority considered the request of M/s Abbott Healthcare Pvt. Ltd and noted that [the] company has near monopoly (around 98% market share) for these critical medicines for leprosy and a sudden discontinuation could lead to shortages. It was therefore decided to direct the company to issue a public notice and continue production/import/sale for a period of 12 months beyond intended date of discontinuation or date of public notice whichever is later,” the minutes show.

The authority also directed to simultaneously request the Department of Pharmaceuticals to invoke para 3 of DPCO, and in case the company applied for upward price revision under para 19, “the same shall be considered as per modalities to be decided by SCAMHP [Standing Committee on Affordable Medicines and Health Products] cases already under their consideration.”

Public health experts, however, point out that the government allowed to continue the monopoly of the private firm instead of making efforts to direct public sector undertakings to take up production of the essential drug.

Clofazimine is one of the three essential drugs for the multi-drug treatment of multibacillary leprosy cases along with rifampicin and dapsone. It is being used in leprosy patients with extremely painful, disabling and long-recurring conditions to bring down the dose of steroids. Though the other two drugs are easily available, clofazimine is not. Its non-availability could lead to a dangerous situation as all the three drugs will have to be given together to prevent drug-resistant leprosy.

Sources said when there was allegation of misuse of the drug oxytocin in cows and it being rarely used in children, the Union Ministry of Health and Family Welfare had restricted its production for domestic use and banned its import in July 2018. Only Karnataka Antibiotics & Pharmaceuticals Ltd, a public sector company, was allowed to manufacture the drug for domestic use.