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Inclusion of one isomer does not imply inclusion of all other isomers: NPPA
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Gireesh Babu, New Delhi
December 29 , 2022
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The expert committee of National Pharmaceutical Pricing Authority (NPPA) has declared a fixed dose combination (FDC) of levosalbutamol, ambroxol hydrochloride and guaiphenesin to treat cough with mucus as not a new drug, observing that the inclusion of one isomer of a molecule in the Schedule I of the Drugs (Prices Control) Order, 2013 does not imply inclusion of all other isomers of a molecule.
The opinion of the Multi Disciplinary Committee (MDC) of experts is based on the expanded and freshly added explanations under the DPCO, 2013 after its amendment of the Schedule I of the Order replacing the National List of Essential Medicines (NLEM), 2015 with NLEM, 2022. The Department of Pharmaceuticals (DoP) notified the amended DPCO on November 11, 2022.
The price regulator received an application from Himachal Pradesh-based Naxpar Pharma (manufacturer) and Goa-based Geno Pharmaceuticals (marketer) for retail price fixation of levosalbutamol sulphate IP 5 ml equivalent to levosalbutamol 1 mg + ambroxol hydrochloride IP 30 mg + guaiphenesin IP 50 mg.
Salbutamol is a scheduled formulation appearing in the revised Schedule I of DPCO, 2013 based on the National List of Essential Medicines (NLEM), 2022. It was also a scheduled formulation under NLEM 2015 which was in the Schedule I of DPCO, 2013 prior to the amendment.
Following the application, the matter was placed before the committee to deliberate whether the formulation of Geno Pharmaceuticals is a new drug under Para 2(1)(u) of DPCO, 2013 and whether salbutamol and levosalbutamol are the same.
According to the particular para of DPCO, 2013, a new drug for the purposes of the price control order shall mean a formulation launched by an existing manufacturer of a drug of specified dosages and strengths as listed in the NLEM by combining the drug with another drug either listed or not listed in the NLEM or a formulation launched by changing the strength or dosages or both of the same drug of specified dosages and strengths as listed in the NLEM.
The Committee was also expected to look at whether levosalbutamol can be considered to be included in Schedule I of DPCO, 2013.
The committee observed that the explanation under the amended DPCO, 2013 with NLEM, 2022, different isomers of a molecule may differ with respect to potency/pharmacodynamics/safety efficacy profile. Such different isomers have been considered as separate entities.
"Therefore, inclusion of one isomer of a molecule in this schedule does not imply inclusion of all other isomers of a molecule," added the Explanation 3 of the amended DPCO, 2013.
The amended Order has a newly added explanation that prodrugs/analogues/derivatives of one active moiety are available as different medicines. They may differ with respect to potency/pharmacokinetics/pharmacodynamics/ safety-efficacy profile. Inclusion of one form of such medicines in the schedule will not imply inclusion of other forms, it elaborates.
"In view of the above, the committee opined that Salbutamol and levosalbutamol are different drugs. Levosalbutamol is an isomer of salbutamol, inclusion of salbutamol in the schedule I of DPCO, 2013 does not imply inclusion of levosalbutamol unless specifically stated," said the MDC.
"Therefore, the FDC of levosalbutamol sulphate IP equivalent to levosalbutamol 1 mg + ambroxol hydrochloride IP 30 mg + guaiphenesin IP 50 mg is not a new drug as per Para 2(1)(u) of DPCO, 2013," it concluded.
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