As India generics under global glare, govt says players being targeted

The government is batting for domestic generic drug makers and exporters of medicines. A statement by the commerce ministry on Monday said vested interests might be raking up isolated issues to mar India's image as an exporter of low-cost generic medicines.

"There are reasons to believe vested interests are raking up the isolated issues reported regarding technical deficiencies on manufacturing and GMP (good manufacturing practices). India is enjoying a unique position in low-cost manufacturing and highest-quality medicine - the best of both the worlds. The government has strong reason to believe some of the spurious drugs detected in the international markets, alleged to be exported from India, are desperate attempts by other countries being affected by the strength of the Indian pharma industry," the statement said.

Last month, Ranbaxy had pleaded guilty to making fraudulent statements to US authorities for securing drug approvals. The company had also agreed to pay a fine of $500 million to the US Department of Justice. Following this, various reports questioned the quality and efficacy of generic medicines. Industry experts suggested the Ranbaxy case might impact the image and reputation of the Indian pharmaceuticals industry, known for its low-cost quality drugs.

While concern and speculation on the generic industry facing hurdles in securing new contracts continue, the government said the US Food and Drug Administration penalising Indian companies was "only a small aberration".

The government, along with the industry, has initiated string of measures to tackle the situation. The Centre is already working on a 'track and trace' mechanism, which would enable monitoring the supply chain at all the levels---primary, secondary and tertiary.

"In due course, online application filing and tracking system would be evolved to bring in sufficient expediency and transparency in the entire supply chain," the statement said.

The government has also expressed enthusiasm to meet international requirements for exports of pharmaceutical products by taking steps to comply with the new procedural requirements of the European Union (EU) for import of active pharmaceutical ingredients into the EU.

According to commerce ministry data, India is the largest exporter of formulations, in terms of volume, with a market share of 14 per cent. In 2012-13, India exported pharmaceuticals worth $14.5 billion. The US is the largest market for Indian generic drug makers, followed by the UK.