You cannot discontinue critical medicines without Prior Notice: NPPA tells Abbott, Bayer Zydus Pharma, Sanofi
New Delhi: In a bid to prevent shortages of critical drugs in the country, the nodal drug price regulator, National Pharmaceutical Pricing Authority (NPPA) has recently directed drug makers including Abbott Healthcare, Bayer Zydus Pharma and Sanofi Synthelabo not to discontinue critical medicines for malaria, leprosy and anti-arrhythmic (cardiac) without prior notice.
NPPA has decided to direct the firms to issue a public notice and continue production/import/sale for a period of 12 months beyond the intended date of discontinuation or date of public notice whichever is later.
The direction came during the 70th NPPA meeting held a month ago. The companies had sought approval for discontinuation of critical medicines, for instance, in case of;
- Abbott Healthcare, 2 scheduled formulations namely Hansepran 50 mg (Clofazimine Capsule IP 50mg) and (ii) Hansepran 100 mg (Clofazimine Capsule IP 100mg) under para 21(2) of DPCO, 2013 were considered.
- Bayer Zydus Pharma for discontinuation of scheduled formulation Resochin (Chloroquine Phosphate Tablet IP 250mg Tablet)
- Sanofi Synthelabo (India) Pvt. Ltd. for discontinuation of scheduled formulation Adenocor 6mg/2ml (Pack of 6 vials of 2ml each)
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It was noted that Abbott Healthcare has near monopoly (around 98% market share) for these critical medicines for leprosy, Bayer Zydus Pharma has about a 12% market share for Resochin, critical medicine for Malaria whose major producer IPCA Laboratories Ltd has also applied for discontinuation while Sanofi Synthelabo (India) Pvt. is observed to be the largest player with 43.62% market share.
It was, therefore, decided to direct the Companies to issue a public notice and continue production/import/sale for a period of 12 months beyond the intended date of discontinuation or date of public notice whichever is later as sudden discontinuation could lead to a shortage.
NPPA further directed to simultaneously request Department of Pharmaceutical (DoP) to invoke Para 3 of DPCO 2013 which will allow the Government to regulate the marketing of drugs, in case of emergency, or in case of non-commercial use in public interest with a view to achieving its adequate availability.
"In case Company applies for upward price revision under Para 19 of DPCO 2013 the same shall be considered as per modalities to be decided by SCAMHP for cases already under their consideration, " NPPA said.
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