National Pharmaceutical Pricing Authority

BY FAX/SPEED POST
(Fax: 079-26582100)

F.No. 20(7)/2013/DP/Div. II/NPPA
Government of India
Ministry of Chemicals & Fertilizers
Department of Pharmaceuticals
National Pharmaceutical Pricing Authority

5^th / 3^rd Floor,
YMCA Cultural Centre Building,
1, Jai Singh Road, New Delhi – 110001

Dated : 31.01.2013

The Managing Director
Torrent Pharmaceuticals Ltd
Torrent Housae,Off Ashram Road,
Ahmedabad – 380 009

Subject: Review Order No. 31015/10/2012-PI.I dated 15^th January, 2013 against the Review application dated 29^th November, 2012 by Torrent Pharmaceuticals Limited under para 22 of DPCO, 1995 in respect of Human Mistard® 40iu, Human Actrapid® 40iu, Human Mixtard® 50 40iu and Human Insulatard® 40iu manufactured by Torrent under license from Novo Nordisk India Private Limited (Insulin Formulations) and against the NPPA notification no. S.O. 2734(E) dated 16^th November, 2012.

Sir,

Kindly refer to your letter dated 29^th January, 2013 addressed to Secretary, Department of Pharmaceuticals with a copy marked to the Member Secretary, NPPA stating that “Taking into account, the directions given in the Review Order, we are permitted to sell the Insulin Formulations at the pre-revised retail price fixed by NPPA vide Notification S.O. 162(E) dated 21^st January, 2010 for Torrent till the Review Order is implemented in totality by the NPPA”.

In this connection, the undersigned is directed to state that the interpretation/assumption stated in your letter is misconceived, totally incorrect and not borne out of the facts contained in the Review Order issued by the Department of Pharmaceuticals vide Order No. 31015/10/2012-PI.I dated 15^thJanuary, 2013. The Review Order of the Department of Pharmaceuticals has not suspended the operation of the notification of the ceiling price issued by NPPA vide its notification No. SO 2734(E) dated 16^th November, 2012. In the absence of any stay order on the price notification, the price notification shall remain in force until further notification is issued for revising the prices.
In this connection, it may be noted that the notified price should be compulsorily followed while filing review application under DPCO 1995. Relevant provision under Para 22 DPCO, 1995 is as follows:

“……Provided that pending a decision by the Government on the application submitted under the above paragraph, no manufacturer, importer or distributor, as the case may be, shall sell a bulk drug or formulation, as the case may be, at a price exceeding the price fixed by the Government of which the review has been applied for”.

As already stated, the review order has not suspended the operation of the ceiling price notification. In view of the above, it is amply clear that the ceiling price notified vide notification S.O. 2734(E) dated 16^th November, 2012 should be compulsorily followed until any further price revision notification is issued by the competent authority, failing which it will attract the penal provisions under DPCO, 1995.

In view of the above facts, you are directed to follow the ceiling price notified vide SO 2734(E) dated 16^thNovember, 2012. You are also required to submit the Form V of the DPCO and compliance report may be sent to NPPA immediately.
This office has not received any price revision application after the review order dated 15^thJanuary, 2013 as per the recommendations stated in Para 2. You may submit the price revision application under DPCO, 1995, if so desired for appropriate action by NPPA.

This issue with the approval of Chairman, NPPA.

Yours faithfully,

Sd/-
(S.K.Bhatt)
Deputy Director (Pricing)

Copy to:

M/s.Lupin Ltd.,159, C.S.T. Road, Kalina, Santacruz (East), Mumbai – 400098, Fax: 022-66402051/52
M/s Eli Lilly and Company (India) Pvt. Ltd.,Plot no 92, Sector-32, Gurgaon – 122001, Haryana, Fax: 1244753012,13,14
Shri R.K.Maggo, Deputy Secretary, Department of Pharmaceuticals, New Delhi-110001

Last Page Updated: 22-01-2019

Note :Website Content Managed by National Pharmaceutical Pricing Authority Ministry of Chemicals and Fertilizers, Designed, Developed and Hosted by National Informatics Centre Services Inc.(NICSI)

LETTER