National Pha rmaceutical Pricing Authority (NPPA), drug price regulator took a number of decisions which includes the directing certain companies to make sure the availability of critical drugs and exempting a “novel” oncology formulation from price control.
Major pharma companies including Healthcare, Bayer Zydus Pharma Sanofi Synthelabo asked by NPPA to not discontinue critical medicines for malaria, leprosy and anti-arrhythmic (cardiac) without prior notice to prevent their shortages in the country.
NPPA received letters from the companies to discontinue the manufacturing/marketing of these medicines. Abbott Healthcare also approached to discontinue for leprosy drug Hansepran, Bayer Zydus Pharma for malaria medication Resochin, and Sanofi Synthelabo for cardiac medicine Adenocor. Sudden discontinuation could lead to drug shortages, and NPPA has asked these companies to issue a public notice, and continue production/import/sale for 12 months after that.
NPPA has asked the department of pharmaceuticals to invoke a Drug Price Control Order (DPCO), 2013 provision that give power to the government to issue directions to producers for regulating distribution of medicines, in case of emergency, or in case of non-commercial use in public interest with a view to achieving its adequate availability. This is for the case of Hansepran, in which Abbott has around 98% market share.
Drug regulator also exempted price control restriction from Sun Pharmaceutical’s “novel’’ oncology injection, gemcitabine hydrochloride. And it deferred a decision on cardiac stents (MeRes100) by Meril Life Sciences, due to safety concerns. Sun Pharma’s ready-to-use infusion bags of gemcitabine hydrochloride also get an exemption from price control, as it is helpful in administration to patients.
Both the Pharma companies had filed for price exemption on their drugs under para 32 (ii) of DPCO, 2013. Under this, the Drug regulator can exempt drugs from price control which are either new or have a new delivery system that is developed through indigenous research, or have a process patent.
Gemcitabine hydrochloride is available in powder form and soon it has to be reconstituted. The company will launch the ready-to-administer injection soon in India. Oncology injection from Sun Pharma’s is premixed in a sterile environment and will be supplied in ready-to-administer bags, preventing problems of over or under-dosing, and risk of contamination.
The Standing National Committee on Medicines also noted that there is still no clinical study has been done to suggest that the company’s oncology injection offers a significant therapeutic advantage.
All India Drug Action Network, NGO raised safety concerns and in the wake of NGO’s concerns Drug regulator, NPPA also decided to defer a decision on Meril’s bioresorbable vascular scaffold system, MeRes100 which dissolves naturally in the body. All the concerns and issue has been referred to drug controller general and ministry of health and family welfare.