The year 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.

Unprecedented rise in EU seizures

European Union customs 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 one lakh crore rupee 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 threatened to drag EU to WTO.

USFDA's hardening stance

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

It opened offices in Hyderabad, Mumbai and Delhi for close monitoring of good manufacturing practice (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 Pharmaceuticals from selling drugs produced in its three units located in the Michigan State of USA.

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.

Wockhardt's woes…

On the exports front, Indian firms suffered losses because of volatility in dollar rates. Wockhardt, which was badly hit by the forex fluctuations, had to go in for corporate debt restructuring.

The Mumbai-based company was forced to sell its non-core businesses. In June, it sold Animal Healthcare business to a French veterinary care company, Vetoquinol, for Rs 170 crore and towards the end of July, it sold its entire nutritional business to Abott for Rs 625 crore.

Wockhardt sold 10 of its hospitals to private chain Fortis Healthcare for Rs 900 crore, the biggest ever deal in the segment. Wockhardt had sold these hospitals and other non-core businesses to repay a part of its Rs 3700 crore debt.

Sources said the company was also in talks with a number of multinationals for partnering in its bio-tech business.

Overall, throughout the year, Indian companies remained on the radar of multinationals looking for buyouts to give a push to their generic business.

While Pfizer acquired the Vetnex Animal Health Ltd, a company owned by ICICI venture capital that deals in veterinary drugs, French drug firm Sanofi Aventis increased its stake in Shantha Biotech.

Besides this, GlaxoSmithKline (GSK) and Pfizer entered into sourcing pacts with Dr Reddy's Lab and Aurobindo Pharma respectively for getting assured supply of generics.

Both GSK and Pfizer were in news all through the year as both the multinationals were aggressively looking for buyouts in India.