America a sweet pill for Indian firms
mid-day.com By: Amriteshwar Mathur May 26, 2003
For US pharmaceutical companies this may be a bitter pill to swallow. Indian pharmaceutical companies are giving US multinationals, who dominated global research, a run for their own money.
Indian pharma companies are spreading their wings both in USA and in Latin America. And surprisingly it is the quality of the Indian drugs that is appealing to consumers globally.
During the last five years, the share of Indian applications to United States Food and Drugs Administration (USFDA) for selling bulk actives has risen from 1.8 per cent to 6.2 per cent of all such applications received by the drug regulator. Quality is high and some Indian products have found a place in the WHO lists of essential drugs.
Says Shahina Mukadam, pharma analyst, Motilal Oswal Securities, “with its numerous FDA filings companies like Indian companies have demonstrated their ability to successfully contest and win against giants like Glaxo Plc which is essential to survive in US markets.”
Even in Latin America, Indian pharma exports have climbed to $1400 million in 2002-03 from $980 million in 2001-02. But it is the $16 billion Latin American domestic market, that Indian pharmaceutical companies are targeting through joint ventures and by setting up manufacturing bases.
The rush has started. Alembic Ltd. is planning to join hands with certain US based formulators to expand its bulks drugs business. As a first step in this direction, Alembic has filed four drug master files with the USFDA with more applications for the next two-three years.
Glenmark Pharmaceuticals has set up a wholly owned subsidiary Glenmark Pharmaceuticals USA, Inc, based in Princeton, New Jersey, to make further inroad into the US market. Dr Reddy`s Laboratories has filed an Abbreviated New Drug Application (ANDA) with the USFDA for ondansetron hydrochloride tablets and for fexofenadine HC1 tablets.
Ranbaxy Laboratories Ltd., which is ranked eight in the US market has received a tentative approval from the USFDA to make and sell a variety of drugs.
Says Dipak Chattaraj, president Ranbaxy Pharmaceuticals Incorporation (USA), “this further helps strengthens our expanding product portfolio and our commitment to bring generic alternatives into the US healthcare system. The approval is yet another testimony to our strong intellectual and regulatory expertise.”
Even in Latin American companies like Ranbaxy, Dr Reddy’s, Aurobindo Pharma and Hetero Drugs have set up plants in countries like Venezuela, Chile and Brazil.
The reason Latin Americans perceive Indian drugs as better in quality compared to Chinese drugs, and so they are looking for supply tie-ups with Indian firms.