DoP Appeals To Emergency Statement, Orders Fulford To Maintain Viraferonpeg Production

In a rare and conclusive move, the Department of Pharmaceuticals (DoP) has invoked the powers under Section 3 of Drug Price Control Order (DPCO) and guided Fulford India Limited, a subsidiary of US-based MSD, to keep up normal production and distribution level of ViraferonPeg 100 mcg infusion.

While invoking the emergency statement, the DoP has referred to the acute shortage of ViraferonPeg, a prescription drug utilized primarily to treat chronic hepatitis B and C infections. The product is also powerful in the treatment of multiple myeloma, follicular lymphoma, and hairy cell leukemia.

The Section 3 of DPCO permits the government in instances of emergency or non-commercial use to guide any producer to ensure satisfactory accessibility of medications or devices in public interest. It also supports the government to regulate the distribution of products.

The drug manufacturer is requested to keep up the same level of production and accessibility from during November 2013-2015. It should also present a weekly report and production plan for the following week to the department and the National Pharmaceutical Pricing Authority (NPPA). The order is legitimate for three months.

DoP Appeals To Emergency Statement, Orders Fulford To Maintain Viraferonpeg Production

ViraferonPeg injection has been short to find the country over for a few months now. As per industry sources, the organization has stopped the manufacturing and distribution of the drug in India. Even well-known online pharmacies such as 1mg and MedPlusMart show ‘sold out’ message for the medication, which contains the active ingredient peginterferon alfa-2b, an immunomodulator.

It might be noticed that the drug price controller, in a request issued in May 2016, had capped the retail price of peginterferon alfa-2b alongside in excess of 50 other critical and essential drugs.

“The regulator’s turn has led many drug manufacturers to limit or stop production of essential medicines with capped costs. This is making a shortage in the market. The NPPA should review the policy in fixing ceiling price to ensure that the accessibility of essential prescriptions isn’t abridged,” a former director of drug control who asked for anonymity pointed out.

The decision of the government to invoke Section 3 in the case of ViraferonPeg is essential as India is among the 11 nations carrying about 50 percent of the global burden of chronic hepatitis. Also, around 12 million individuals are accounted for to be suffering from hepatitis C in the country, six times the number of HIV/AIDS patients. The country is resolved to achieve the elimination of viral hepatitis by 2030 and has launched a comprehensive three-year National Action Plan for viral hepatitis.

 

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