Pharma 2009: No medicine to cure adversity

Indian pharma industry found that it had no medicine to cure adversities that came its way in 2009 -- when it battled shipment seizures by EU authorities, tightened US regulations, Chinese drug piracy and currency fluctuations.

The year also witnessed Mumbai-based Sun Pharmaceutical continue the tussle for taking over Israeli drug firm Taro, while MNCs struck alliances with Indian companies to capitalise on generics expertise here.

European Union custom authorities continued to seize generic drug shipments from India, undermining the country's efforts to emerge as a reliable supplier of affordable medicines globally.

There was an unprecedented rise in EU's seizure of shipments en-route to Latin American and African countries on allegations of violation of intellectual property rights.

EU seized 18 such consignments and it was bad news for India's Rs one lakh crore pharma industry, which gets around 45 per cent of its revenue through exports.

India also found itself protesting against Chinese selling fake 'Made in India' drugs.

Africa and Latin America are major markets for India's low cost drugs used for treatment of diseases like HIV/AIDS, tuberculosis and malaria and account for 25 per cent of total pharma exports of around Rs 45,000 crore.India accused the EU of violating global trading norms by confiscating drugs and threatened to take EU to WTO.

Industry experts said EU moves were unethical as the drugs seized were neither patented in India, nor in the destination countries.

Commerce and Industry Minister Anand Sharma and Head of EU delegation to India Daniele Smadja said that the issue would be discussed at the highest level. India has also threatend to drag EU to WTO.

The year also saw US health regulator, Food and Drug Administration (FDA), hardening stance against drug firms.

It opened offices in Hyderabad, Mumbai and Delhi for close monitoring of good manufacturing practise (GMP) norms by Indian firms.

FDA also reduced response time, filed by companies to its notices, from 30 days to 15 days.

Meanwhile, in May FDA issued notices to Lupin alleging deviation from GMP norms. In November, it banned Caraco, a US-based subsidiary of Sun Pharmaceutical from selling drugs produced in its three units located in Michigan state US.

However, Ranbaxy Laboratories which is facing a ban on 30 generic drugs manufactured at two of its facilities located in Paonta Sahib, Himachal Pradesh and Dewas, Madhya Pradesh, tried to resolve its issues with FDA but the matter is still hanging fire.