India's largest drug manufacturer, Ranbaxy Laboratories, had falsified data and test results of medicines manufactured at its Himachal Pradesh facility to obtain marketing approval in the United States, says the US Food and Drug Administration.
At least 38 per cent, or 8.3 million square feet, of its projected commercial space of 21.4 million square feet in its six parks will thus remain indefinitely on hold. The rentals from all these parks were expected to generate revenues for its AIM-listed associate Unitech Corporate Park, which has invested pound 317 million to acquire majority stakes in all the six seed projects in return of leasing rights.
The move comes 18 months after the cash-strapped developer was allotted 35 acres by the Delhi Development Authority to build and maintain an international convention & exhibition centre, hotels and allied commercial facilities. The cost of the project is estimated at Rs 6,000 crore (Rs 60 billion) and was expected to be completed in three years.
Ever since the government announced that state-owned banks will provide home loans up to Rs 20 lakhs (Rs 2 million) at not more than 9.25 per cent for the first five years, real estate developers have started working their prices around the Rs 20-lakhz (Rs 2-million) figure. Dozens of real estate developers have announced homes at below Rs 25 lakhs (Rs 2.5 million) in the National Capital Region of Delhi.
Property developers expect to boost sales of homes and borrow funds at lower rates after the Reserve Bank of India on Friday reduced its key benchmark rate and cut the cash-reserve ratio requirement in a bid to help banks lower interest rates and lend more to cash-starved sectors, including the real estate. They are hopeful of attracting more overseas investment in projects as demand revives.
DLF, India's biggest real estate developer, has repaid dues and may not need to approach lenders to take advantage of a central banks relaxed rule that allows banks to restructure cash-strapped real estate companies loans.
Roche expects to start selling Actemra by April 2009, company sources said. India will be the second country to launch the drug, Japan being the first. The Indian drug regulator Drug Controller General of India usually approves a new drug marketing application based on safety and efficacy data cleared by regulators in the US, EU and other developed countries.
After launching mid-income houses, real estate companies are now targeting low-priced homes in the sub-Rs 10 lakh (Rs 1 million) category to improve cash flows and beat the slump in the property market that has been driven by high borrowing rates.
First time, an Indian court revisits a patent office order.
Paul Herrling, global head of Novartis' corporate research, spoke to Business Standard about the changing concepts in R&D and Novartis' strategy.
While Daiichi Sankyo acquired a majority share in the country's biggest drug-maker Ranbaxy, Eisai and Astellas have chosen to set up wholly-owned subsidiaries to promote their patented medicines in the country. In a communication to the Nikkei Stock Exchange on November 18, Astellas said its subsidiary Astellas Pharma India in Mumbai was set up as a marketing arm to sell its immunology and urology medicines.
The US Department of Health and Human Services has decided to employ 10 full-time officials in Delhi -- a country director, four drug inspectors, two senior technical experts in medicines, two technical experts in medical devices and one from the food sector. 'The purpose of the appointment is to help develop food and medical product regulations and agencies improve product safety and conduct inspections in a more timely manner,' said Christopher Kelly, press officer, USFDA.
It plans to make Hyderabad as its back office hub for data management in clinical research and financial service segments. Novartis is putting infrastructure to put all these people in one place and the centre is expected to turn operational next year. It will be the back office for Novartis' pharmaceutical operations and will find many PhDs and post-graduates working there, said Jurgen Brokatzky-Geiger, head (human resources), Novartis.
It did come as a surprise when, last week, Religare Enterprises (promoted by the former promoters of Ranbaxy) decided to acquire a majority stake in the ailing Lotus India Asset Management Company. This is the first deal in India since the financial crisis caused the market to crash 23 per cent in October, and Lotus' assets under management from Rs 7,000 crore (Rs 70 billion) to about Rs 5,000 crore (Rs 50 billion).
A government committee that is looking into the possibility of pre-marketing price negotiation for patented medicines is likely to recommend a lenient view on such medicines, it is learnt. A government committee that is looking into the possibility of pre-marketing price negotiation for patented medicines is likely to recommend a lenient view on such medicines, it is learnt.
Even as the debate over safety and essentiality of genetically modified foods continues, Indian research institutes are trying to genetically modify some high-value medicinal herbs that are an integral part of ayurvedic medicine, a recent report of pro-environment group Greenpeace has said.
The US Congressional committee, which is inquiring into the country's Food and Drug Administration's handling of drug-marketing approvals of India's leading drug-maker Ranbaxy, has extended its probe into similar permissions given to Iceland's Actavis.
In a move aimed at encouraging the growth of innovation-driven industries, the Ministry of Science and Technology has proposed to set up special innovation zones that will offer a host of fiscal incentives for research and development companies in India.
The World Health Organization has given five more months to the Drugs Controller General of India to upgrade its performance to international standards. The extension of the current deadline of October-end came after a visiting WHO team found the modernisation programmes of the Indian drug regulator on track.
Sun generates 41 per cent of its annual revenues from the US market, a record of sorts among Indian drug firms. The company is bullish on its US prospects and expects 25 per cent growth in the country this year, higher than the 18-20 per cent growth projection it has given for other markets including India. The US is the world's largest market for medicines and accounts for nearly 50 per cent of the $780 billion global medicine sales.
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