Launching product without Approval: DOP rejects Biocon Plea against NPPA action

New Delhi: Through a recent decision, the Department of Pharmaceuticals rejected the review applications filed by biopharmaceutical major Biocon against the decision of the National Pharmaceutical Pricing Authority (NPPA).

Biocon, in its application, had challenged NPPA's retail price fixation of Blistro Trio 1 (containing Metformin Hcl (SR/ER/PR) 500+Voglibose 0.2mg+Glimepride 1mg tablet) and Blistro Trio 2 (containing Metformin Hcl (SR/ER/PR) 500+Voglibose 0.2mg+Glimepride 2mg tablet). NPPA had fixed the prices in 2017

Biocon in its application contended that Blistro Trio 1 and 2 are being manufactured by Hetero Labs Ltd. and Biocon is only marketing the said products. Further, Hetero Lab has already taken the retail price approval from NPPA.

"NPPA's stand of inclusion of M/s Biocon Ltd., fixing the retail prices of the said products, on the ground that the applicant company launched a new drug without obtaining a prior price approval is incorrect and erroneous," stated the plea

However, NPPA stood for the inclusion of Biocon fixing the retail prices of the said products which is not agreed to by the company.

It is reported that the company has also filed a plea with the Delhi High Court in order to seek quashing of the demand notice and price fixation orders by the NPPA for the mentioned drugs. The court directed the matter to the DOP to be heard and disposed off in a judicious and expedite the matter.

Before the DOP, the company held that one of the ingredients of the said formulation namely Metformin Hcl (SR/ER/PR) 500+Voglibose 0.2mg+Glimepride 1mg and Metformin Hcl(SR/ER/PR) 500+Voglibose Page 2 of 4 0.2mg+Glimepride 2mg tablet on the date of launch of the formulations, were part of the NLEM 2011. Metformin Hcl(SR/ER/PR) 500 is different from Metformin Hcl 500. Thus, the said formulations could not be stated to be new drug in terms of DPCO.

Furthermore, the company contended that NPPA did not observe the procedure laid down in paragraph 9(4) of DPCO. The paragraph states that the market data for fixing the retail price of the new drug for the month ending immediately before six months of receipt of an application for fixing the prices of new drug is to be taken into consideration.

Thus, the data for the month of November, 2016 should have been taken into consideration by NPPA, as the application was filed by the company in May, 2017.

Bengaluru-based Biocon also contended that since the company is not the existing manufacturer of the formulation and is only marketing the product being manufactured by Hetero Labs, at a price less than what was notified for Hetero Labs, the overcharged amount including interest and penalty levied by NPPA will not be applicable to them.

Commenting on the challenges thrown, NPPA stated that Biocon did not take price approval before launching of Blistro Trio 1 tablet containing Metformin Hcl(SR/ER/PR) 500+Voglibose 0.2mg+Glimepride 1mg. and Blistro Trio 2 tablet containing Metformin Hcl(SR/ER/PR) 500+Voglibose 0.2mg+Glimepride 2mg. Moreover, NPPA's said approval is applicable for Hetero Lab Limited Ipca Lab Limited only for their product Glyree MV1 and Glyree MV2.

"In regard to the contention of Biocon that under NLEM 2011 only Metformin tablet 500 mg is mentioned but their products contain Metformin Hcl 500mg (SR/ER/PR) and hence their products do not fall under the definition of new drug," states NPPA.

NPPA stated that since under NLEM 2011, Metformin 500mg was included without differentiating its other variants, therefore, all variants, i.e. CR/SR/ER are considered as included. Hence, the contention of the applicant that Metformin 500mg tablet CR/SR/ER is not included in NLEM is not tenable.

The regulatory body complied that since Biocon launched the product without taking prior price approval, NPPA issued show cause and demand notices as a followup action.

Examining the entire issue, DoP has rejected Biocon's review order stating that the application is devoid of merit.

The order was issued on the 22nd day of February 2019.

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