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The Department of Pharmaceuticals (DoP) has rejected the review applications filed by Biocon against the fixation of retail price 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).
Earlier, Biocon had filed two separate review applications under paragraph 31 of the DPCO-2013 against notification S.O. No. 3727(E), dated 23.11.2017 issued by the National Pharmaceutical Pricing Authority (NPPA).
In the review applications, the petitioner claimed that formulations Blistro Trio 1 and Blistro Trio 2 are being manufactured by Hetero Labs and Biocon is only marketing the said products. Hetero, prior to the launch of the said products, has already taken the retail price approval from the NPPA. NPPA’s stand of inclusion of Biocon, 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.
None 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 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, Biocon argued in its review petitions.
The petitioner further argued that the NPPA did not follow the procedure as laid down in paragraph 9(4) of DPCO. In terms of the said paragraph, the market data for fixing the retail price of the new drug for the month ending immediately before six months of receipt of 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 applicant in May, 2017. Since the applicant was 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, the petitioner stated.
During examination, the reviewing authority DoP noted that the NPPA fixed the retail price of metformin Hcl 500mg (in sustained release form)+glimepride 1mg+voglibose 0.2mg (brand name Glyree MV1) at Rs.8.46/tablet and metformin Hcl (SR/ER/PR) 500+voglibose 0.2mg+glimepride 2mg (brand name Glyree MV2) at Rs.10.47/tablet for Hetero Labs and IPCA Laboratories vide SO 936(E) and SO 938(E), both dated 27th March, 2014, respectively. The retail price approval for new drug is given on the basis of Form I submitted by the manufacturer/marketer and is applicant specific. No other company can manufacture or market the said product with its own brand name. The contention of the applicant that since Hetero Lab, the manufacturer of the said formulation, has taken price approval for the subject formulations, and the applicant is only marketing the said products and therefore was not required to take prior approval for retail price of its formulations, has got no merit.
The DoP further noted that the contention of the applicant is that under NLEM 2011 only metformin tablet 500 mg is mentioned but their products contain metformin Hcl 500mg(SR/ER/PR) and hence it do not fall under the definition of new drug. 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 subject formulations qualify as new drug. In view of this, the second issue raised by the applicant in its review applications also has got no merit
The DoP also noted that the contention of the applicant that NPPA should have considered the data of November, 2016 by following the procedure as laid down in paragraph 9(4) of DPCO has got no merit, as the applicant started marketing the products since November, 2014 without taking prior price approval.
The Schedule-I of DPCO was revised in March, 2016 (NLEM 2015) and metformin Hcl 500mg was in the list of scheduled formulations. In the cases of new drugs which were being manufactured/marketed without price approval, the retail prices were fixed taking the data of August, 2015 (six months prior to March, 2016, when the Schedule-I was revised). In view of this, NPPA has rightly fixed the retail price of said formulations by considering August 2015 data. Since Biocon launched the products manufactured by an existing manufacturer without taking prior price approval, NPPA was justified in issuing show cause notices and demand notices as a follow up action, the DoP noted while examining the review petitions.
In view of the above, all the issues raised by the company in its review applications are devoid of merit. Hence, the review applications deserve to be rejected, the DoP in its order said.
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