DoP rejects review petitions of Reddy’s, Abbott against ceiling prices fixed by NPPA

Joseph Alexander, New DelhiTuesday, October 29, 2013, 08:00 Hrs  [IST]

In a crucial order regarding the prices fixed by the National Pharmaceutical Pricing Authority (NPPA) as per the new pharmaceutical policy and the Drug Price Control Order 2013, the Department of Pharmaceuticals (DoP) has rejected the review petitions by Dr Reddy’s Laboratories and Abbott Healthcare filed against the ceiling of prices on their products.

Dr Reddy’s had challenged the order of the NPPA dated June 21, 2013 against fixing the ceiling price of omeprazole 20 mg capsules, fixed under the new DPCO. The Department held the personal hearing on August 16 on the case, before the rejecting the petition.

“The issues involved in the review application have been examined based on the record note of discussions of the personal hearing and other documents on record,” according to the department. “Review application of the Petitioners is rejected on the grounds that price fixed by NPPA is as per the provisions of DPCO, 2013,” the order issued by the Department said.

The order is significant because there were more than 120 brands of omeprazole 20 mg alone were brought under the control and the order will impact them. All main companies like Alkem, Mankind, Micro Labs, Ranbaxy, Wockhardt, Zydus Cadila, Abbott, Aglowmed, Albert David, Alembic, Alpha Drugs, Anglo French Drug, Apex, Aristo Pharma, Blue Cross, Cadila, Cipla, Elder Pharma, Ind-Swift, Intas Pharma, Medley Pharma, Natco Pharma, Novartis Intl, Omega Remedies, Parenteral Drugs, RPG Life Sciences, Torque Pharma, Torrent Pharma etc have their brands of omeprazole. Companies like Ranbaxy and Cipla have as many as seven brands for this formulation.

Likewise, there were several brands of omeprazole 10 mg which was also put under the price control. Many of the companies are having more than one brand for this formulation. The review order will have impact on other brands too.

Abbott Healthcare had challenged the notification (S.O. No 1569(E) dt.14.6.2013, 1877(E) and 1918(E)) by the price regulator dated 28.6.13 fixing ceiling price of phenobabitone tablets, 60mg, and 30mg and promethazine injection, 25mg/ml. This formulation is also marketed by several companies under different brands. The hearing was held on July 31 and the government went through the case.

“The review application of the petitioners is rejected on the ground that NPPA strictly followed the provisions contained in DPCO, 2013, PTR (price to retailer) of the company when compared with the others show that they were charging 200 per cent to 300 per cent more than other companies and they cannot be allowed to overcharge as per provisions of DPCO, 2013.”

“However, the additional information brought to the notice of NPPA may be cross examined by them with the help of IMS Health and if deemed necessary, NPPA may revalidate such data by appropriate survey or evaluation as authorised under para 9 of DPCO, 2013,” the order said.