(Published in Part II, Section 3, Sub-section (ii) of

the Gazette of India, Extraordinary, dated the 23^rd January, 2008)

Government of India

Ministry of Chemicals and Fertilizers

National Pharmaceutical Pricing Authority

New Delhi, the 23^rd January, 2008

ORDER

S.O.129(E) – Whereas the National Pharmaceutical Pricing Authority was established vide the Resolution of the Government of India in the Ministry of Chemicals and Fertilizers No. 33/7/97-PI.I dated 29^th August, 1997 inter alia, to fix prices and notify the changes therein, if any, of bulk drug and formulations, monitor the prices of decontrolled drugs and formulations and oversee the implementation of the provisions of the Drugs (Price Control) Order.

2. Whereas the Ministry of Chemicals and Fertilizers vide S.O. 637(E) dated 4^th September, 1997 in pursuance of paragraph 26 of the Drugs (Price Control) Order, 1995 (DPCO, 1995) and thereafter delegated the powers in respect of specified paragraphs of the DPCO,1995 to be exercised by the National Pharmaceutical pricing Authority on behalf of the Central Government.
3. Whereas the National Pharmaceutical Pricing Authority monitors the prices of decontrolled (non-scheduled) formulations on the basis of data on price available in ORG IMS on regular basis and wherein, from the data obtained from ORG-IMS it was observed that price of Ondem 2ml vial formulation pack manufactured by M/s. Zen Pharma (P) Ltd and marketed by M/s. Bergen Healthcare (a division of M/s. Alkem) increased by more than 10% during the period from June, 2006 to June, 2007. The concerned company was therefore directed to furnish the reasons for such price increase in pursuance thereof. The reply from the company was examined and it was observed that the price increase by more than 10% during the relevant year, for the above said formulation pack, was unjustified and against public interest in as much as it puts an unreasonable burden on the consumers without sufficient justification.
4. Now, therefore, in exercise of the powers delegated under sub-para (b) of Para 10 and 11 of the Drugs (Prices Control) Order, 1995 vide S.O. No. 637(E) dated 4^th September 1997 issued by the Government of India in the Ministry of Chemicals and Fertilizers, and thereafter, the National Pharmaceutical Pricing Authority being satisfied that it is necessary in the public interest so to do, hereby notifies the maximum retail price including excise duty and local taxes, of the following formulation pack manufactured by M/s. Zen (P) Ltd. and marketed by M/s. Bergen Healthcare (a division of M/s. Alkem), as per the details herein under:-

* subject to actual payment of excise duty.

5. The maximum Retail Price fixed for the above mentioned formulation pack shall be implemented by M/s. Zen (P) Ltd. and marketed by M/s. Bergen Healthcare (a division of M/s. Alkem) within 15 days from receipt of this order by issuing a price list in form V in accordance with the provisions of paragraph 15 of DPCO, 1995.
6. Failure of the above said company to implement the Maximum Retail Price fixed, as above, within the stipulated aforesaid time shall attract action under Paragraph 13 of DPCO, 1995 for recovery of overcharged amount along with any and all other appropriate action, under the provisions of DPCO, 1995 read with the Essential Commodities Act, 1955.
7. The manufacturer / marketing company for the above said formulation shall be required to take the requisite prior approval from the competent Authority for any change in the composition of the above said formulation with written prior intimation to the National Pharmaceutical Pricing Authority.
8. The manufacturer/marketing company for the above said formulation shall be jointly and severally responsible to comply with this order and conditions mentioned herein above.

(P.K.Saha)

Dy. Director(Cost)

(F. No. 20(245)/2008/Div-IV/NPPA)

The Managing Director/CEO,

M/s. Zen Pharma (P) Ltd.,

75/1, GIDC,

Vapi – 396 196.

Gujarat.

The Managing Director/CEO,

M/s. Bergen Healthcare (Division of M/s. Alkem),

“Alkem House”, Senapath Bapat Marg,

Lower Parel,

Mumbai – 400 013.