NPPA looks into fixation of retail price of drugs under phase IV clinical trials

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The National Pharmaceutical Pricing Authority (NPPA) may fix the retail price of formulations which are under phase IV clinical trials based on the company’s application submitted to the central drug regulator for conducting the phase of clinical trials and other documents along with the relevant form.

The Authority deliberated the issue of retail price fixation of drugs under phase IV clinical trials after it received applications from the companies. Considering that the matter involves the approval of the drug regulator, the Authority took the view of the representative of Central Drugs Standard Control Organisation (CDSCO) into consideration.

A K Pradhan, joint drug controller, CDSCO, clarified the Authority that the phase IV clinical trials are to be conducted by the companies for the drugs that are classified as ‘D’ category drugs by the Kokate Committee and the drugs are in the market as per the approval of State Licensing Authorities (SLA), hence the companies need to apply to the Drugs Controller General (India) for permission to conduct phase IV clinical trial.

The Kokate Committee, which looked into the safety and efficacy of the fixed dose combinations (FDCs), approved by the state drug regulators but which fall under the definition of new drugs and without the approval of the central drug regulator, has categorised the FDCs into four categories. The Category D, according to this, are the FDCs which require further generation of data for confirming the safety and efficacy.

The official said that a No Objection Certificate (NOC) is issued by the drug regulator subject to fulfillment of certain conditions by the company.

However, since the drug is already approved by SLA and has to be in market, the retail price may be fixed by the NPPA based on the copy of application submitted to DCGI for conducting phase IV Clinical Trials, or the NOC issued by the DCGI or the license issued by the central drug regulator, along with the Form I.

The Form I, according to the DPCO, 2013, is an application for price fixation or revision of a new drug formulation related to the formulations in the National List of Essential Medicines (NLEM). The particular form seeks data on the formulation, its manufacturer or importer, details of the approval from the drug regulatory authorities, package size, and retail price claimed for approval, reason for submission of application for price fixation or revision, among others.

It may be noted that the drug price regulator has been in the process of revising the ceiling prices of scheduled formulations listed in the Schedule I of the DPCO, 2013, after it has revised the Schedule replacing the National List of Essential Medicines (NLEM), 2015 with the latest NLEM, 2022. The total unique formulations for which ceiling prices are to be fixed are around 819 and it has already notified prices of 119 formulations and approved 97 ceiling price calculations till the end of December, 2022.

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