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Ramesh Shankar
Wednesday, May 17, 2023, 08:00 Hrs  [IST]

The multi disciplinary committee of experts of the National Pharmaceutical Pricing Authority (NPPA) has recently recommended to the national drug pricing authority to examine the launch of ibuprofen injection by three companies - Cipla, Hetero Healthcare and Sandor Medicaids - without price approval from the Authority. Earlier, Cipla had submitted an application with the NPPA to fix the retail price of its product Ibuprofen IP 100 mg and the expert committee considered the matter on January 20, 2023. Cipla claimed a retail price of Rs. 25.78, while the committee, considering that the data of ibuprofen 100 mg is not available in the Pharmatrac database, recommended the retail price at Rs. 5.05 by applying the price fixing formula to the price of diclofenac injection 25 mg/ml, which has been fixed already under the Schedule I of DPCO, 2013. The ceiling price of diclofenac injection 25 mg/ml was at Rs. 1.63, as on March 30, 2022. The committee then sought Cipla to respond on two aspects, prior to proceeding further with the application. It asked where there is any therapeutic advantage of giving ibuprofen injection as against diclofenac injection in terms of efficacy, safety or any other terms. If the equivalent dose of diclofenac injection and ibuprofen injection are used in any therapeutic indication, then what will be the cost of treatment using each of these drugs. Once again, Cipla approached the committee with a representation on February 7, stating that the drug with same dosage and strength is imported and sold by one company at almost double the price of what Cipla has claimed. It said that while it has claimed a price of below Rs. 30, the imported drug is sold at Rs. 74.375 per ml. Then the expert committee in its next meeting directed the NPPA to collect data from Sandor Medicaids and SG Pharma, and ten hospitals including All India Institute of Medical Sciences (AIIMS), Delhi. The committee deliberated on the data received from the hospitals and the companies and asked the NPPA to examine the launch of ibuprofen injection/infusion by these three companies without price approval from NPPA.

Launching a new drug without the price approval from the NPPA is a serious issue. In fact, overcharging of drug prices has been a major issue ever since the first Drug Price Control Order was announced by the government way back in 1979 to make essential drugs available at affordable prices. Violations of the DPCO provisions by way of either circumventions or overcharging by the pharmaceutical companies have been going on in the country with impunity. As the government brought more drugs under DPCO in 1995, monitoring of drug prices became a daunting task for the government. It was under this backdrop, NPPA was established by the Union Chemicals & Fertilizers Ministry way back in 1997, exclusively to monitor and control the prices of drugs in the country. The ministry's action in this regard was prompted by the fact there was rampant violation of DPCO by the pharmaceutical companies which was evident from the fact that there were hundreds of court cases being fought by the NPPA in various parts of the country to recover thousands of crores from different pharma companies. The NPPA's task of monitoring and controlling the drug prices became manifold when the government added more drugs in the DPCO. For whatever reason, the NPPA should not allow the companies to launch new drugs without price approval from it. Otherwise, the very purpose for which it has been formed will not be served. The NPPA should deal such cases with a heavy hand.


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