NPPA Rejects AstraZeneca Plea and Sets Retail Price for Micro Labs Dapagliflozin + Metformin Formulation

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On the grounds that it is a pricing authority and cannot decide on patents, the National Pharmaceutical Pricing Authority (NPPA) rejected AstraZeneca’s plea regarding Micro Lab’s representation for the tablet to prolonged release of Dapagliflozin + metformin hydrochloride.

The formulation was part of a list of 26 formulations published by the NPPA on September 25 under the Medicines (Price Control) Ordinance 2013 relating to the 78th meeting of the Authority on September 14, 2020. This is the second DPCO list of September 2020 published by the NPPA.

In its statement to the NPPA, AstraZeneca informed the NPPA that the company holds the patent in India for these formulations. However, it is also noted that Sun Pharma Laboratories and Abbott Healthcare have launched these formulations with the prior approval of the Price of Authority.

According to an industry observer, the decision by the innovative company (AstraZeneca) to voice its objection to the NPPA draft worksheet (which was uploaded to the NPPA website) was a bad one. decision because the NPPA is not the authorized authority to deal with patent matters.

Malini Aisola, co-host of AIDAN, replied: “The NPPA has taken a correct position in rejecting AstraZeneca’s objections on the basis of its patent. India’s legal framework does not allow a link between patents. “

According to some information, based on the decision of the NPPA at its 77th meeting on August 6, 2020, he mentioned that the authority noted that the representation made by AstraZeneca on the draft worksheet uploaded to the NPPA website and ordered him to submit it to the authority after consideration of the same. It is assumed that based on the innovator’s request, the retail pricing of Dapagliflozin + Metformin for Micro Labs combinations has been postponed.

However, civil society groups approached the NPPA authority with a request to share the representation made by AstraZeneca to understand the nature of the objections.

At the 78th authority meeting under the chairmanship of Shubhra Singh, chairman of the NPPA, held on September 14, 2020, the NPPA referred to an office memorandum dated August 8, 2019 issued by the Ministry of the Promotion of Industry and Internal Trade (DPIIT), Ministry of Trade and Industry which has stated that there is no provision in the TRIPS Agreement providing for an obligation for member countries to provide a patent link, that the Indian Patent Act, 1970 does not contain any provision to link patent rights to the marketing approval of a product and that the NPPA is a pricing authority and may not be technically qualified to decide the existence and scope of a patent in a proposed formulation.

The Authority also recalled that at its 72nd meeting on January 20, 2020, during which it was decided “that the benefit of the price reduction in the event of non-patent formulations should be passed on to consumers in public interest and decided to set the retail price to the retailer price (PTR) based on the Form V data submitted by the companies for which retail prices were previously approved for these FDCs in question.

The Authority further noted that Sun Pharma Laboratories and Abbott Healthcare have launched these formulations with prior price approval and, therefore, the retail price set by the Authority for these companies is empty. 957 (F) of 03.03.2020 on the basis of the decision taken at its 73rd meeting on February 25, 2020 2.

However, Sun Pharma Laboratories and Abbott Healthcare did not submit Form V indicating the revised price as required under the provisions of the DPCO 2013. Accordingly, the authority decided to consider the matter for non-submission and has requested clarification for this non-compliance, if applicable.

In addition, the authority also deliberated on the matter in detail and observed that since Sun Pharma Laboratories and Abbott Healthcare had not submitted Form V, the retail price can be set on the basis of the sale price. retail given to these companies SO vacuum. 957 (E) of March 3, 2020. In addition, the NPPA Authority observed that the patents for these formulations are held by AstraZeneca and therefore decided not to take into account the data of AstraZeneca’s product when setting the retail price to pass on lower prices for off-patent items to consumers in the public interest.

Micro Labs’ Dapagliflozin + Metformin combined formulation is an extended release tablet and available in two strengths, 500 mg and 1000 mg, with a price per tablet of Rs 40, 44 and 42 respectively.

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