NPPA dismisses AstraZeneca’s plea and fixes retail price Dapagliflozin + Metformin formulation of Micro Labs

On the grounds that it is a pricing authority and cannot decide on patents, the National Pharmaceutical Pricing Authority (NPPA) has dismissed AstraZeneca’s plea regarding Micro Lab’s representation for the Dapagliflozin + Metformin Hydrochloride Extended-Release tablet.

The formulation was part of a list of 26 formulations released by the NPPA on September 25 under the Drugs (Prices Control) Order, 2013 relating to the 78th Authority meeting dated 14.09.2020. This is the second DPCO list of September 2020 issued by the NPPA.

In its representation 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 prior price approval from the authority.

According to an industry observer, the initiated move by the innovator firm (AstraZeneca) about expressing the objection on the draft working sheet of NPPA (which was uploaded on the NPPA’s website) was a wrong move as the NPPA is not the authorised authority to deal with matters related to patents.

Malini Aisola, Co-Convenor, AIDAN responded, “NPPA has taken a correct position in dismissing AstraZeneca’s objections on the basis of its patent. India’s legal framework does not allow for patent linkage.”

Reportedly, based on NPPA’s decision in its 77th meeting dated August 6, 2020, it mentioned that the authority noted that representation made by AstraZeneca on the draft working sheet uploaded on the NPPA’s website and directed it to place before the authority after examination of the same. It is assumed that based on the innovator’s request the retail price fixation of Dapagliflozin + Metformin combinations for Micro Labs was deferred.

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.

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

The authority also recalled that in its 72nd meeting dated January 20, 2020, in which it was decided “that benefit of price reduction in case of formulations becoming off-patent ought to be passed on to the consumers in public interest and decided to fix the retail price as per the Price To Retailer (PTR) based on Form-V data submitted by the companies for whom retail prices were earlier approved for these subject FDCs.

The authority further noted that Sun Pharma Laboratories and Abbott Healthcare have launched these formulations with taking prior price approval and accordingly, the authority fixed retail price for these companies vide SO. 957(E) dated 03.03.2020 based on the decision taken in its 73rd meeting dated February 25, 20202.

However, Sun Pharma Laboratories and Abbott Healthcare have not submitted the Form-V showing the revised price as required under the provisions of DPCO 2013. Accordingly, the authority decided to examine the matter for non-submission and sought clarification for such non-compliance, as applicable.

Besides this, the authority also deliberated upon the matter in detail and observed that since Sun Pharma Laboratories and Abbott Healthcare had not submitted Form-V, the retail price may be fixed based on the retail price given to these companies vide SO. 957(E) dated March 3, 2020. Further, the NPPA Authority observed that the patents of these formulations are held by AstraZeneca and accordingly decided not to consider the data of the product of AstraZeneca while fixing the retail price so as to pass on the benefit of lower prices of off-patent items to consumers in the public interest.

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