NPPA Directs Neon Laboratories To Continue Manufacturing Of Tropine Inj For 6 More Months

New Delhi : The National Pharmaceutical Pricing Authority (NPPA) has decided to further extend its direction to Mumbai-based Neon Laboratories to continue manufacturing scheduled formulation atropine injection 0.6 mg/ml, a drug to treat bradycardia or slow heart rate, for six more months. Neon Lab has earlier submitted Form IV seeking the drug price regulator’s permission to discontinue the drug under the drug control order.

The Authority, in a meeting held on June 28, deliberated upon the company’s request and decided that Para 3 of Drugs (Prices Control) Order, 2013, be invoked in relation to Neon Laboratories Ltd for the scheduled formulation Tropine 1ml injection (atropine sulphate injection 0.6 mg/ml) for sims more months, upto February 5, 2023.

The decision is taken under the Para 3 of Drugs (Prices Control) Order, 2013, which includes directions to manufacturers of active pharmaceutical ingredients (API) or bulk drugs or formulations, under which the government may direct any manufacturer of any API or bulk drug or formulation to increase the production and to sell such ingredients to other manufacturers and to sell the formulations to institutions, hospitals or any other agency.

Neon Laboratories has submitted its application seeking discontinuation of the drug, under DPCO 2013, and in an earlier meeting on May 20, 2020, the Authority observed that Neon Laboratories is the largest player with 83 per cent market share for the formulation atropine sulphate injection 0.6mg/ml, marketed as Tropine 1ml injection. Earlier, NPPA through its letter dated January 6, 2020, has directed the company to continue production or import and sale of the product upto June 20, 2021.

Simultaneously, the case was also referred to the Committee constituted for examination of cases under Para 21 of DPCO, 2013, to inform urgency or emergency for invocation of Para 3 of DPCO, 2013. In the 4th meeting of this Committee, held on May 13, 2020, the Committee recommended that this is an essential medicine and hence discontinuation may not be allowed.

The Para 21 of the DPCO, 2013 stipulates that the government shall monitor the production and availability of scheduled formulations and the APIs contained in the scheduled formulation and the manufacturer of the scheduled formulations and the APIs contained in the scheduled formulation shall furnish the information as stated in the DPCO, quarterly.

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 the DPCO in this regard at least six months prior to the intended date of discontinuation. The Government may, in public interest, direct the manufacturer of the scheduled formulation to continue with required level of production to 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.

A meeting held on July 29, 2021 directed the company to continue production of the drug for six months, which was later extended to September, this year, according to officials.

Tropine 1ml injection, which belongs to the class anticholinergics, is used to treat bradycardia or slow heart rate. It is also used to regain normal heartbeat at the time of cardiac arrest. The drug is also useful in treating eye diseases like myopia and uveitis.

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