DCGI Initiates Investigation On Antipsychotic Drug ‘Restonorm’ Manufactured Without Permission

New Delhi : The National Pharmaceutical Pricing Authority (NPPA) has fixed the ceiling price of antipsychotic drug risperidone injection (long acting) 25 mg in its latest meeting after deferring the price fixation earlier due to a dispute raised by multinational pharma major Johnson & Johnson (J&J) against including the price of a formulation, manufactured by another company allegedly without permission from the Drugs Controller General of India (DCGI).

The DCGI has initiated an investigation on the drug under the brand Restonorm, manufactured by HFA Formulations Pvt Ltd and marketed by Aleteus Biogenics Ltd, following the NPPA seeking status of approval from the drug regulator. The drug is used for treatment of schizophrenia and similar mental health disorders.

The drug price regulator as part of its ongoing exercise to revise the ceiling price for the scheduled formulations under the revised Schedule I of the Drugs (Prices Control) Order, 2013, released a draft calculation sheet for 45 formulations including risperidone injection (long acting) 25 mg on January 6, 2023.

The calculation sheet listed formulations from two companies with market share of one percent and above, including Risperdal Consta from Janessen, part of J&J and Restonorm from Alteus Biogenics Pvt Ltd. Based on these two product details, the Authority calculated the ceiling price as Rs. 1,316.40 per unit.

Following this, the Authority received a representation from J&J dated January 13, 2023, that the brand Restonorm is manufactured by HFA Formulations Pvt Ltd, and the Central Drugs Standard Control Organisation (CDSCO) has not received the application from HFA Formulations for manufacturing of the drug.

The Authority, in its meeting held on January 27, decided to seek clarification from the DCGI with respect to the approval status of the drug, and deferred the price fixing process for the formulation.

The price regulator has said that following this, the letter was sent to the DCGI and in response, on March 22, the drug regulator informed that no permission has been issued to HFA Formulations for risperidone long acting injection 25 mg/ml. “Further, DCGI has initiated an investigation in this respect,” added the Authority following the latest meeting held in the beginning of this month under the chairmanship of Kamlesh Kumar Panth, chairman of NPPA.

NPPA on April 10, once again released the draft calculation sheet for the formulation – this time excluding the data on HFA Formulations – and arrived at a price of Rs. 1,930.19 per unit for the formulation with an average rate of reduction of 22.40 per cent, under the monopoly clause.

“Accordingly, the Authority noted that the ceiling price of Rs. 1,930.19 per ml is calculated only on the basis of one line item (i.e. excluding HFA Formulations Pvt Ltd) after applying monopoly clause as per Para 6(1) of DPCO, 2013,” said the drug price regulator.

For risperidone injection (long acting) 37.5 mg, the price has been fixed as Rs. 2,649.26 per ml, in the same meeting held in the beginning of this month.

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