Last Updated on September 20, 2021 by The Health Master
The National Pharmaceutical Pricing Authority (NPPA) has directed Novartis India to maintain normal production, distribution and availability of its pain relieving medicine Voltaflam 50 mg in the market, even though the company applied to discontinue the scheduled formulation.
The decision comes at a time when the Authority and Novartis are locking horns in the Delhi High Court in a related matter. Novartis, in 2020-21, has made an online launch of Voltaflam TH, as part of its life cycle management strategy.
Novartis has submitted application for discontinuation of Voltaflam 50 mg (diclofenac potassium BP 50 mg), a non steroidal anti-inflammatory (NSAID) drug for pain relief, and the Authority, has referred it to the Standing Committee related to discontinuation of scheduled formulations.
The Standing Committee, in a meeting held in early September, recommended that the company may be directed to maintain normal production, distribution and availability of the drug in the market till a related matter is finally decided by the Court.
It says that the drug Voveran GE 50 mg gelatin coated tablet (diclofenac sodium) having market share of 56 per cent and Voltaflam 50 mg having market share of 7.15 per cent are of the same composition – diclofenac.
“The company has priced Voveran GE, substantially higher than the ceiling price of diclofenac. The matter as to whether Voveran GE would be considered as a scheduled formulation is pending before the Hon’ble High Court,” it said. The discontinuation of Volflam 50 mg could be decided after this matter gets decided by the Court, said the Authority in a recent meeting.
Novartis filed a Writ Petition on May 8, 2014 before the Delhi High Court challenging the move of the NPPA to include Voveran 50 GE tablets, marketed by the company, under price control in terms of the Drug Price Control Order 2013.
During the pendency of the Writ Petition, the NPPA issued a show cause notice on September 24, 2014 alleging over charge on sales of Voveran 50 GE tablets by the company. The company responded to the show cause notice through its letters on October 13, and 27, 2014.
The NPPA issued a demand notice on October 31, 2014 directing the company to pay Rs. 28.18 crore, including interest, in 15 days. This demand was challenged by the company before the Delhi High Court.
The Delhi High Court passed an order restraining the NPPA from taking coercive steps in respect of the aforesaid demand. The matter was posted for further hearing on 28th May, 2021 however it was adjourned due to Covid-19.
“The company is awaiting a further date for hearing from the Court registry. In the opinion of the company, Voveran 50 GE tablet is not covered under the category of essential medicines under the National List of Essential Medicines and, hence, is a non-scheduled drug under DPCO, 2013.
Therefore, Voveran 50 GE tablet cannot be brought under the regime of price control under Paragraph 14 of the DPCO, 2013,” said the company in its Annual Report for the year 2020-21.
The company’s pain portfolio has recorded growth during the year 2020-21, owing to the focused sales, increased marketing efforts and integration of a robust digital push driving growth of the flagship portfolio of orals and injectables, it added.
As part of its life-cycle management strategy, the company during the fiscal year launched Voltaflam TH, a new product in the combination market for treatment of pain due to muscle spasm, online.
The success of this initiative will pave the way for more such ventures in the future, it said. The company was the number two Multinational pharma company in the Indian pain market during the year 2020-21, said the report.