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DoP rejects review application of Premium Serums on “Specific Anti-Snake Venom Lyophilized Polyvalent Serum”
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Ramesh Shankar, Mumbai
July 30 , 2016
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The Department of Pharmaceuticals (DoP) has rejected the review
application of Premium Serums & Vaccines Pvt. Ltd filed against
fixing of ceiling price of “Specific Anti-Snake Venom Lyophilized
Polyvalent Serum” by the National Pharmaceutical Pricing Authority
(NPPA).
The NPPA vide its notification S.O. No.838(E) dated
25.03.2015 had fixed the ceiling price of “Specific Anti-Snake Venom
Lyophilized Polyvalent Serum”. Aggrieved by the notification, Premium
Serums & Vaccines approached the DoP, which is the reviewing
authority, and field a review application against the NPPA order.
During
the hearing held on 1.6.2016, the petitioner contended that the NPPA’s
price notification of 2015 for Anti-snake Venom Serum was based on
average price of existing manufacturers in 2012. It was made applicable
in March, 2015 for lyophilized products. They submitted that their
company started selling this product in August, 2014 onwards. They
submitted that the old companies had already recovered their capital
investment in the preceding years whereas, being a new company, their
cost of establishment and the cost of production is high. Due to
enforcement of new price notification, the difference between
prenotification price and post-notification price is almost 40 per cent
reduction in MRP. This has resulted into drastic reduction in the
revenue generation by the company than projected.
In response,
the NPPA stated that this product is covered u/s 4.2.2. and 19.2.2 of
schedule I of DPCO 2013 and NPPA has fixed the ceiling price of this
formulation as per para 4, 10, 11, 14 & 16 of DPCO, 2013, as in case
of other scheduled formulations. There is no separate provision/ground
in the DPCO, 2013 to consider the request made by the company.
Therefore, the company is advised to follow the existing price.
The
DoP examined the case point by point mentioned by the company in its
review application. The company mentioned that the notification does not
specify the composition. The composition in each 1 ml of snake venom
Antiserum neutralizes not less than 0.60 mg of Indian Cobra Venom, 0.45
mg of common Krait venom, 0.60 of Russell’s viper venom, 0.45 mg of saw
scaled viper venom. The company representative mentioned that the
specific composition should be notified to bring clarify. DoP found that
entries at S.NO.4.2.2 and 19.2.2 of Schedule I of DPCO, 2013, does not
give the break up of neutralization dose. Therefore, the action of NPPA
to fix the price is in order.
The company mentioned that the
average price of May, 2012 was considered by NPPA while WPI for the year
2012 given in 2013 has not been given. In this point also, company has
no merit as DPCO 2013 came into effect in May, 2013 and upto May 2013,
the prices as prevailing in the market before DPCO 2013 were applicable.
The company mentioned that their manufacturing process of
anti-snake venom is different from the chemical products. They are new
manufacturer and, therefore, their pricing should be treated
differently. Since, the criteria for fixing the ceiling/retail price
under DPCO 2013 is market based instead of cost based, there is no
provision for differential pricing. Hence, there is no merit in the
point raised by the petitioner.
After examination, the DoP ordered, “In view of the above facts, review application of the company stands rejected”.
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