NPPA rejects Novartis plea to discontinue painkiller Voltaflam

New Delhi: Rejecting Novartis India Limited's proposal for discontinuation of scheduled formulation viz., Voltafalm 50mg, the National Pharmaceutical Pricing Authority (NPPA) has recommended the company to maintain normal production, distribution, and availability of Voltaflam 50mg in the market.

This came in response to the form-IV intimation received from Novartis India Limited for discontinuation of a scheduled formulation, viz., Voltafalm 50mg (Diclofenac Potassium BP 50mg) under Para 21 (2) of DPCO, 2013.

According to the DPCO,2013, form IV is a proforma for submission of the details in respect of the discontinuation of the production and/or import of a scheduled formulation.

Para 21(ii) of DPCO 2013 says, "Any manufacturer of scheduled formulation, intending to discontinue any scheduled formulation from the market shall issue a public notice and also intimate the government in Form-IV of schedule-II of this order in this regard at least six months prior to the intended date of discontinuation, and the government may, in the public interest, direct the manufacturer of the scheduled formulation to continue with the required level of production or import for a period not exceeding one year from the intended date of such discontinuation within a period of sixty days of receipt of such intimation."

The Authority, at its 224th meeting, held on September 8th, 2021, under the Chairmanship of Shri Kamlesh Kumar Pant, Chairman, NPPA, extensively investigated the drug-maker Novartis India Limited's form-IV intimation for discontinuation of a scheduled formulation, viz., Voltaflam 50mg.

Voltaflam 50 Tablet belongs to a class of drugs known as nonsteroidal anti-inflammatory drugs (NSAIDs). It is used for short-term relief of pain, inflammation, and swelling in conditions that affect joints and muscles. It acts by blocking the chemical effect of an enzyme called cyclo-oxygenase (COX) which produces prostaglandins which are responsible for the sense of pain and inflammation produced at the sites of injury and damage.

Regarding the Novartis proposal for discontinuation of a scheduled formulation viz., Voltafalm 50mg (Diclofenac Potassium BP 50mg) under Para 21 (2) of DPCO, 2013, the NPPA Authority noted that the matter was referred to the Standing Committee.

The Standing Committee observed in its 5th meeting on 02.09.2021, that the drug Voveran GE 50 MG Gelatin Coated Tablet (Dicofenac Sodium) has a market share of 56 percent, while Voltaflam 50mg' ( Diclofenac Potassium BP 50mg) has a market share of 7. 15%, and that both drugs have the same composition "diclofenac."

Further, the Standing Committee noted that 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.

Accordingly, the Standing Committee recommended, " Till the matter is finally decided by the Hon'ble Court, the company may be directed to maintain normal production, distribution, and availability of Voltaflam 50mg in the market."

In light of the above recommendation, the authority concluded,

"The Authority deliberated upon the matter in detail and accepted the recommendation of the Committee and decided that till the matter is finally decided by the Hon'ble Court, the company may be directed to maintain normal production, distribution and availability of Voltaflam 50mg in the market."

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