India passes the drug Patent Bill

Mar 23 2005

India's parliament passed a new law Wednesday, the Patent (Amendment) Bill, prohibiting the copying of patented drugs, despite strong criticism that the legislation would prohibit the manufacture of low-cost generic drugs.

The bill was passed by the 250 member upper house of parliament the day after it was approved by 545 member lower house on Tuesday. The opposition staged a walkout in both the houses.

The approval paves the way for the bill, which prohibits domestic firms from copying low-cost generic versions of patented drugs, to become law.

Health activists said the law would affect the provision of cheaper generic drugs to millions of HIV-AIDS and cancer sufferers in poorer countries, a claim disputed by drugs firms.

The bill is an attempt to ensure India falls in line with World Trade Organisation rules and replaces legislation which allows drug makers to copy patented products using a different manufacturing process.

Commerce Minister Kamal Nath told parliament that concerns over the rise of medicine prices were baseless as only 10 out of the 195 drugs currently being sold in the domestic market would be covered by the new patent law, which affects only drugs patented after 1995, and procedural complications means it will take at least three years to secure patents for those 10 drugs.

Oxfam and the World Health Organisation (WHO) were among those to voice concern that the law would have international ramifications, especially for those living with HIV-AIDS and cancer in poorer countries.Oxfam's regional policy advisor Samar Verma says because India is one of the world's biggest producers of generic drugs, the law will have a severe knock-on effect on many developing countries which depend on imported generic drugs from India, and they fear that the prices of drugs will be out of reach for millions living with HIV-AIDS in Africa and elsewhere.

The WHO's deputy director for the department of essential medicines, German Velasquez, says they are very concerned and are following the debate very closely. The Geneva-based UN health body had recalled in a letter to Indian Prime Minister Manmohan Singh "the importance of the manufacture in India of generic medicines affects many developing countries".

"People who rely on low-cost medicines will have to wait three years before a generic company can even make an application for a right to produce the drug," said a statement by a group of activists including France-based Medecins Sans Frontieres (MSF) and the Affordable Medicines and Treatment Campaign (India).Poor people will have to wait years until new medicines are proved safe and effective.

MSF says 50 percent of people living with HIV-AIDS in the developing world depend on generic drugs from India, which is the world's fourth-largest producer of medicines by volume but only 13th by value -- an indication of the relative cheapness of its products.

Drug firms dispute the claims that millions of HIV-AIDS and cancer sufferers are threatened by the bill. Bombay-based company Cipla said the new law would not hamper exports of its popular three-in-one anti-AIDS drug cocktail to Africa. Amar Lulla, joint managing director of drug company Cipla, says at present it clearly appears that there is no problem for them to sell these drugs in African countries as they do not fall in the proposed patents purview, and as far as he understands it, patents will be applicable only on new drug discoveries and not on combinations or dosage forms.

A.K. Khanna, director of anti-AIDS drugmaker Emcure Pharmaceuticals, based in the west Indian city of Pune, said that only molecules discovered post-1995 come under the patents law and most anti-AIDS drugs, including those his company produces and sells to Zambia, fall outside this; he does not anticipate any problem selling anti-AIDS medicines to Africa.

Managing director of India's Wockhardt drugs company, Habil Khorakiwala, also confirms that Indian firms would be allowed to continue exporting their cheaper HIV-AIDS drugs as most of their products were generic; the patent law has seen that this market is kept open to our companies, he said.