Pharma sector: Leading Russian insulin maker to invest USD80m

ISLAMABAD: The leading Russian pharmaceutical company M/s Genetics Pharmaceuticals/M/s Zavod Medsintez LLC, producing insulin, will invest approximately USD80 million in Pakistan’s pharma sector over the next six years.

In this connection, the Drug Regulatory Authority of Pakistan (DRAP) has conditionally fixed the Maximum Retail Price (MRP) for six insulin products of the Russian pharmaceutical company, namely M/s Genetics Pharmaceuticals/M/s Zavod Medsintez LLC, while directing the company to immediately start working on the construction of local manufacturing plants and fully complete it by December 2031.

In a notification issued here on Monday, the DRAP says, “In exercise of the powers conferred by clause (a) of section 7 of the Drug Regulatory Authority of Pakistan Act,20l2 (XXI of 2012)read with section 12 of the Drugs Act, 1976 (XXK of 1976), the DRAP with the approval of the federal government is pleased to fix maximum retail prices specified in column (4) of the Table below on which the drugs specified in column (2) thereof, having packing sizes specified in column (3) of that table, shall be sold, subject to the specified conditions.”

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According to the notification, the maximum retail prices (MRPs) shall be subject to the following conditions: (i) This price revision is granted on the explicit understanding that M/s Genetics Pharmaceuticals/M/s Zavod Medsintez LLC shall immediately start the establishment of the relevant manufacturing facility plant and commencement of local production of API in the following two stages. (a) The first stage is the construction of an aseptic filling plant - approximately USD20 million. Completion of construction of the unit for bulk import and a dedicated Biological Unit for Aseptic Filling of Insulin and its derivatives until December 31, 2028; (b) the second stage is the construction of an API production plant - approximatelyUSD60 million. Development of a project and transfer of technology production of biotechnological products (insulins) from the API, ie, from Purification of API till packaging of finished form - C Biotech until December 31, 2031. (ii) The company shall share stage-wise detailed timelines for investment. DRAP shall monitor the progress. In case of non-compliance with the commitment of setting up a manufacturing facility and manufacturing in Pakistan, the product registration shall be cancelled.

The DRAP has approved MRP for the following Russian insulin products. (i) Rosinsulin C 100IU/ml, Insulin Isophane (N) 10 ml suspension for subcutaneous administration produced by m/s ZavodMedsintez (ZavodMedsintez, LLC), Russia. Imported by: M/s Genetics Pharmaceuticals (Pw) Ltd, Lahore.

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