In a rare and decisive move, the Department of Pharmaceuticals (DoP) has invoked the powers under Section 3 of Drug Price Control Order (DPCO) and directed Fulford India Limited, a subsidiary of US-based MSD, to maintain normal production and distribution level of ViraferonPeg 100 mcg injection.
While invoking the emergency clause, the DoP has cited acute shortage of ViraferonPeg, a prescription drug used primarily for treating chronic hepatitis B and C infections. The product is also effective in the treatment of multiple myeloma, follicular lymphoma and hairy cell leukemia.
The Section 3 of DPCO allows the government in cases of emergency or non-commercial use to direct any manufacturer to ensure adequate availability of drugs or devices in public interest. It also enables the government to regulate the distribution of products.
The drug manufacturer is ordered to maintain the same level of production and availability as during November 2013- 2015. It should also submit a weekly report and production plan for the next week to the department and the National Pharmaceutical Pricing Authority (NPPA). The order is valid for three months.
ViraferonPeg injection has been in short supply across the country for a few months now. According to industry sources, the company has discontinued the manufacturing and distribution of the drug in India. Even popular online pharmacies such as 1mg and MedPlusMart display ‘sold out’ message for the drug, which contains the active ingredient peginterferon alfa-2b, an immunomodulator.
It may be noted that the drug price regulator, in an order issued in May 2016, had capped the retail price of peginterferon alfa-2b along with more than 50 other critical and essential medicines.
“The regulator’s move has prompted many drug manufacturers to stop or limit production of essential medicines with capped prices. This is creating a shortage in the market. The NPPA should review the policy in fixing ceiling price to make sure that the availability of essential medicines is not curtailed,” a former director of drug control who requested anonymity pointed out.
The decision of the government to invoke Section 3 in the case of ViraferonPeg is crucial as India is among the 11 countries carrying nearly 50 per cent of the global burden of chronic hepatitis. Moreover, about 12 million people are reported to be suffering from hepatitis C in the country, six times the number of HIV/AIDS patients. The country is committed to achieve the elimination of viral hepatitis by 2030 and has launched a comprehensive three-year National Action Plan for viral hepatitis.