WHO clearance to hoist Indian vaccine exports

Over the past few years, India has emerged as a major vaccine producer, targeting geographical regions where vaccines are not funded by the United Nations or charitable organizations. The growing market received a major boost this week with an announcement from the World Health Organization that the country's national regulatory authority and affiliated institutions meet the prescribed international standards to supply vaccines to international bodies such as the WHO, UNICEF and the World Bank.

The Central Drugs Standard Control Organization got word from WHO that it passed strict levels of 7 indicators to meet international standards for providing international bodies with vaccines. A team of 12 international experts headed by a WHO member completed the assessment. Hitting the mark for pre-qualification standards means specific vaccines meet international benchmarks for quality, safety and efficacy.

The go-ahead will likely increase investment in the pharmaceutical sector and nudge along exports, which reached $13 billion last year and are expected to hit $26 billion by the end of 2012, The Hindu reports. The country is home to 12 major vaccine manufacturing facilities and exports to 150 countries. Much of India's vaccines market depends on exports; they made up 65% of the market last year.

The WHO news is welcomed and shows a marked improvement in the industry. In 2007, the CDSCO failed to meet WHO standards, and the international organization suspended manufacturing licenses of three public sector vaccine manufacturing units for noncompliance with good manufacturing practices. India improved for the 2009 assessment and the units moved back into action.

Analysts anticipate a sizable shift in India's vaccine industry landscape in general. A recent report estimates that the vaccine production sector will shoot to an estimated $871 million by 2016, a sizable jump from the 2011 value of the sector, which sat at $350 million. Of course, India will need to contend with another growing vaccines powerhouse in the coming years: China. The Far East country is turning the heat up on India's vaccine industry with the development of larger capacity units.

- read The Hindu's story