The Indian pharmaceutical industry is likely to benefit from a major wave of patent expiries in the US, as small-molecule drugs worth $63.7 billion are expected to go off-patent between 2025-29, a 65 per cent rise over the previous five years, according to a report by Antique stock broking limited.
Financial pressure on the parent company triggered the move.
Closure would mean manufacturer might not be able to launch any new generic products in India in future.
Global generic drugs producer Sandoz has opened its third plant in India at Navi Mumbai with annual production capacity of one billion tablets and capsules.
The board of directors of Novartis India has approved a proposal to sell the Rifampicin bulk drug business, together with its Mahad facility, to Sandoz for Rs 30.77 crore (Rs 307.7 million).
"When the SHO sir asked me about my interest of area, I told him that I am a dance teacher and want to continue it. The SHO sir said that they will try to find me a suitable job. He sent me to Sandoz to restart earning livelihood till the time I get a job in dancing. I am also thinking to apply in schools for dance teacher," Balaji Sawalkar said.
The patent relates to the manufacturing process for the active ingredient in Sanofi-Aventis' Allegra and Allegra-D drug products. Both Dr Reddys and Sandoz are known to be marketing these products in the US.
Abbott Laboratories is suing India's Ranbaxy Laboratories as well as Israel's Teva and Sandoz of the Novartis group, in Chicago for allegedly violating its patents protecting Omnicef, a drug used to treat ear, throat and skin infections.
When Biocon chairperson Kiran Majumdar-Shaw - well known for raising issues ranging from lack of civic services in Bengaluru to climate change - decided to take on the Indian stock market regulator, the Securities and Exchange Board of India (Sebi), she forced the Indian corporate world and legal community to take notice. In an interview to Business Standard, Majumdar-Shaw called a Sebi order to impose a fine on insider trading charges against a Biocon employee and an external consultant an "Agatha Christie" fiction, which destroyed the reputation of "innocent people". "The order is pure harassment and has caused huge reputational damage to us and goes against the principles of good governance promised by this government," Mazumdar-Shaw said. "We will certainly appeal this," she added.
US firm Mylan NV received a stern warning from the FDA in August for faulty manufacturing practices at three of its India drugmaking plants.
As India's drug majors in this segment increasingly trip on American standards, increasing the scrutiny on their practices, their counterparts look up there.
Sebi has barred Allegro Capital and one of its senior executives from the securities market for one year in a case related to alleged insider trading activities in the shares of Biocon. Besides, the market watchdog has directed them to disgorge wrongful gains along with interest. The amount would be more than Rs 24 lakh. Allegro Capital and its director as well as major shareholder Kunal Ashok Kashyap have been fined Rs 10 lakh each, according to an order by Sebi dated July 8.
Legal experts and official sources said the alleged submission of fake documents can also lead to criminal charges against Novartis.
The Indian arm of Swiss pharmaceutical major Novartis AG is set to become the newest entrant in the Ayurvedic business.
Swiss drug maker Novartis might face tough action from the country's drug regulator for allegedly giving fake documents while seeking renewal of registration for Tiamulin Hydrogen Fumerate (80 per cent granules), sources said.
The Indian company that acquires Merck Generics, the multinational drug maker's generics (non-patented) business, up for sale, will be able to compete against the top global players
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Ahmedabad-based Zydus Cadila has made a foray into the US generic formulation segment by setting up a subsidiary Zydus Pharmaceuticals USA, Inc.
Several reports in the media had said the US will make a formal announcement during President Pervez Musharraf's visit to the US beginning June 24.
The drug that it would supply is called Olanzapine, used to treat schizophrenia and bipolar disorder.
An insider said that over the past decade or so Cipla has become immune to the exits of leaders. There have been no directional change in the long-term strategies.
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The Asian markets are largely trading in the green, taking heart from a positive close on Wall Street.
Even smaller companies like Torrent Pharma and Alembic file five to 10 ANDAs every year.
The 30-share Sensex ended 50 points lower at 28,112 and the 50-share Nifty declined 12 points to close at 8,531.