India's government wants the country to become the world's preeminent low-cost vaccine supplier, but it will first have to overcome problems of its own making. A WHO embargo in the late 2000s slowed growth, and isolated quality problems have continued to blight the industry. Panacea Biotec is the latest manufacturer to struggle with quality control.
Last week inspectors froze the sale of more than 15,000 vials of a pentavalent vaccine after discovering that someone had tampered with expiry dates. Vaccines that were due to expire last month were given new labels to extend the stated shelf life by one year, the Times of India reports. Panacea Biotec claims it was given permission to make the change, and new labels were pasted on top of old ones so the work could be done while keeping the vaccines refrigerated.
The controversy is the second time in recent years that the company's pentavalent vaccine has made headlines for the wrong reasons. In 2011 the WHO dropped Panacea Biotec from its list of prequalified pentavalent vaccine suppliers. The WHO action caused a 57% drop in vaccine sales at Panacea Biotec. Other Indian vaccine manufacturers, such as Biological E, have since gained WHO prequalification to fill the gap left by Panacea Biotec.
Missteps such as the relabeling scandal threaten to derail the long-term prospects of the Indian vaccine industry. The goal for former Indian president APJ Abdul Kalam is to see India become the leader in the supply of low-cost vaccines by 2020, the Economic Times reports. Reputation-damaging scandals are one impediment to this goal. The government is potentially another.
Forbes reports that while other countries are initiating pandemic vaccine preparations ahead of the possible spread of H7N9, India is tied up with internal squabbles. The dispute dates back to 2009. The Indian government gave Panacea Biotec, Serum Institute and Bharat Biotech cash to develop cell culture production technology. It also ordered some vaccines. When the flu threat fizzled out, the government canceled the order. It also asked for the cell culture cash back, plus 12% interest. The actions led to a court case and a lot of ill feeling between the companies and government.
"If there is a pandemic or slight epidemic, that time I will strike [the government] hard," Serum Institute founder Cyrus Poonawalla said.