Setback: NPPA panel rejects Neon Labs plea to discontinue local anesthetic Lidocaine

This came in response to the form-IV intimation received from Neon Laboratories Limited for discontinuation of scheduled formulation viz., Lox 5% Ointment (Lidocaine 5%) under Para 21(2) of DPCO, 2013.

According to the DPCO,2013, form IV is a proforma for submission of the details in respect of the discontinuation of the production and/or import of a scheduled formulation.

Para 21(ii) of DPCO 2013 says, "Any manufacturer of scheduled formulation, intending to discontinue any scheduled formulation from the market shall issue a public notice and also intimate the government in Form-IV of schedule-II of this order in this regard at least six months prior to the intended date of discontinuation, and the government may, in the public interest, direct the manufacturer of the scheduled formulation to continue with the required level of production or import for a period not exceeding one year from the intended date of such discontinuation within a period of sixty days of receipt of such intimation."

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The Authority, at its 225th meeting of the Authority, held on 15th of November 2021, under the Chairmanship of Shri Kamlesh Kumar Pant, Chairman, NPPA, extensively investigated the drug-maker Neon Laboratories' form-IV intimation for discontinuation of a scheduled formulation Lidocaine 5% (Lox 5%).

Lox 5% containing the medication Lidocaine, belongs to class of drugs known as local anesthetics which is indicated for local or regional anesthesia.

The Authority, at its recent meeting deliberated upon the matter in detail and decided not to allow discontinuation of scheduled formulation Lidocaine 5% (Lox 5%) of M/ s Neon Laboratories.

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