DCGI launches an investigation into antipsychotic drugs made without authorization.

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In its most recent meeting, the National Pharmaceutical Pricing Authority (NPPA) set a ceiling price for the antipsychotic medication risperidone injection (long acting) 25 mg. Earlier, the price fixation had been postponed because Johnson & Johnson (J&J) complained that it should not be included in the cost of a formulation that was allegedly manufactured by another company without the Drugs Controller General of India (DCGI)’s (DCGI) consent. Following the NPPA’s request for the status of approval from the drug regulator, the DCGI has opened an investigation into the medicine sold under the brand name Restonorm and produced by HFA Formulations Pvt Ltd and distributed by Aleteus Biogenics Ltd. The medication is used to treat schizophrenia and other mental health conditions.

On January 6, 2023, the drug price regulator released a draught calculation sheet for 45 formulations, including risperidone injection (long acting) 25 mg, as part of its ongoing effort to revise the ceiling price for the scheduled formulations under the revised Schedule I of the Drugs (Prices Control) Order, 2013. The calculation sheet included formulations from two businesses with market shares of one percent or more, including Restonorm from Alteus Biogenics Pvt Ltd. and Risperdal Consta from Janessen, a division of J&J. The Authority determined the ceiling price as Rs. 1,316.40 per unit using these two product data.

Following this, the Central Drugs Standard Control Organisation (CDSCO) did not receive an application from HFA Formulations for the manufacturing of the drug. According to a representation from J&J dated January 13, 2023, the brand Restonorm is manufactured by HFA Formulations Pvt Ltd. The Authority agreed to suspend the price-fixing process for the formulation at its meeting on January 27 in favour of asking the DCGI for clarity regarding the drug’s clearance status.

The pricing regulator claims that after this, the letter was sent to the DCGI. In response, the drug regulator notified HFA Formulations on March 22 that no approval had been provided to them for risperidone long acting injectable 25 mg/ml, according to the price regulator. “Further, DCGI has initiated an investigation in this respect,” the Authority stated during the most recent meeting, which was presided over by Kamlesh Kumar Panth, the chairman of NPPA, at the beginning of this month.

On April 10, the NPPA once more produced the draught calculation sheet for the formulation, omitting the information on HFA Formulations this time. The organisation arrived at a price of Rs. 1,930.19 per unit for the formulation with an average rate of reduction of 22.40%, 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 the monopoly clause as per Paragraph 6(1) of DPCO, 2013,” said the drug price regulator. In the same meeting held at the beginning of this month, the price for risperidone injectable (long acting) 37.5 mg was set at Rs. 2,649.26 per ml.

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