Category — Pharmaceuticals

India Calls for Post-Sales Monitoring of Cancer Drugs

An “Apex Committee for Clinical Trials” has been constituted by the Union Health Ministry on the directive of the Supreme Court of India.  Outsourcing Pharma.Com reports that this committee now requires developers of cancer treatments approved without trials to monitor the first 500 patients to assess the drug’s safety and efficacy. An analysis of the data acquired will need to be submitted to the Drugs Controller General of India, who will then forward it to the Technical and Apex Committees for scrutiny.

The new recommendation comes after the marketing approval was granted to Merck’s Zolinza (vorinostat), and Medivation and Astellas’ Xtandi (enzaltuamide), both treatments for cancer. Further, the Apex and the Technical Committees have approved 28 of 31 submissions for clinical trials.

Share:
  • del.icio.us
  • Facebook
  • LinkedIn
  • Twitter

January 11, 2015   No Comments

Merck India Sells Consumer Care Business to Bayer India

Bayer AG has globally acquired the marketing and distribution of consumer care products from Fulford India, a Merck & Co Inc., subsidiary, with effect from January 1, 2015. As part of the global transaction, products such as Alaspan, Polaramine, Tinaderm have been transferred to Bayer Pharmaceuticals Private Ltd.

Share:
  • del.icio.us
  • Facebook
  • LinkedIn
  • Twitter

January 3, 2015   No Comments

Rising Optimism for Doing Business in India

The environment for foreign investments in India started improving a short time before Narendra Modi was elected prime minister on a business-friendly reform agenda in May 2014. United Arab Emirates’ Etihad Airwas acquired a stake in India’s  largest corporate carrier, Jet Airways. As a result of this deal, the U.A.E. ranks in the top five of India’s leading foreign investment sources.

A survey conducted by Ernst & Young found that 53% of more than 500 business leaders around the world planned to enter or expand their operations in India within the following 12 months. The list of multinationals that are making long-term investments in India includes U.K. liquor company Diageo, which acquired majority ownership of United Breweries, once run by Indian billionaire Vijay Mallya; French energy company GDF SUEZ; pharmaceutical giant GlaxoSmithKline; Sweden’s IKEASingapore Airlines; Starbucks, which partnered with the Tata BeveragesUnilever, Vodafone and Volkswagen all upped the ante upon Modi’s eelection.

Over the last year, 67% of foreign direct investment in India has gone go the services sector, with 18% going to the manufacturing sector. The remaining 15% has gone to agribusiness investments, according to the Reserve Bank of India.

FDI in India is capped in a number of key sectors.  Foreign ownership cannot exceed 49% in Indian defense contractors, or 74% in private banking. Nandan Nelivigi, head of India’s practice at White & Case said, “Competition for the best opportunities [in India] is already fierce and will only intensify as the business climate improves. Fortunately, investing in India today is no longer a step into the dark.”

Share:
  • del.icio.us
  • Facebook
  • LinkedIn
  • Twitter

November 17, 2014   No Comments

Hospira gets into R&D and Manufacturing

Lake Forest, Illinois based Hospira acquired an active pharmaceutical ingredient (API) manufacturing facility and an associated research and development facility in Aurangabad from Orchid Chemicals & Pharmaceuticals Ltd., a leading Indian pharmaceuticals company, for $218 million.

“Hospira’s acquisition of the 665 employee Orchid API facility will support supply continuity of key beta-lactam antibiotic products, improve our cost position and pave the way for future API development,” said Dr. C. Bhaktavatsala Rao, president and managing director, Hospira India. In addition the purchase includes an associated Orchid R&D facility based in Chennai, India, that will be directed primarily to beta-lactam and other API development with approximately 110 scientific personnel.

Share:
  • del.icio.us
  • Facebook
  • LinkedIn
  • Twitter

September 18, 2014   No Comments

India: Most Attractive Investment Destination

India has overtaken China as the most attractive investment destination, according to Ernst & Young (EY), with the sharp depreciation in the rupee and opening up of new sectors to foreign players boosting the South Asian nation’s allure. This according to report published on CNBC. Companies are most likely to invest in India, followed by Brazil (2), China (3), Canada (4) and the United States (5), EY’s ninth bi-annual Capital Confidence Barometer – a survey of 1,600 senior executives across more than 70 countries – showed. Other nations in the top 10 are South Africa (6), Vietnam (7), Myanmar (8), Mexico (9) and Indonesia (10).

Sectors with the highest level of possible deals in India include Automotive, Technology, Life Sciences and Consumer Products.

The survey reported that 38 percent of the respondents feel that Merger and Acquisition  volumes in India are expected to improve over the next 12 months, while 30 percent believe that these will remain stable. “The investor outlook for India remains positive, despite the challenges the country’s economy has faced in the recent past. At the same time, the improved condition of the world economy has helped increase confidence amongst deal makers, prompting them to take a bolder stance toward executing transactions,” said Amit Khandelwal, National Leader & Partner — Transaction Advisory Services, EY. “After two years, European countries (Britain and Germany) have made a comeback on the potential investment destinations list for Indian companies,” the report said. In August, the Indian government announced relaxation in foreing investor  norms in many sectors, including multi-brand retail and telecom.

 

Share:
  • del.icio.us
  • Facebook
  • LinkedIn
  • Twitter

December 11, 2013   No Comments