The acceptance of Patents (Amendment) Ordinance 2004 in its current form can not only affect the Indian industry, but can also prove harmful for the growth of global generic drug industry, experts warned. The worst hit would be the generic drug makers of developed countries like the United States who are increasingly depending on Indian bulk drugs for low cost production of off patent drugs in that country.

Addressing a national colloquium on economic and social implications of the new patent regime, William Bill Haddad, former chairman of US Generic Pharmaceutical Industry Association, said that any harm to the Indian bulk drug industry can have its negative consequences in the international generics market.

The Medecins Sans Frontieres (MSF), an international NGO, involved in the procurement of anti AIDS drugs for treating patients world over, also said the active presence of Indian drugs industry in AIDS drug sector is essential for continuing its activities in the least developed countries. Olivier Brouant, Head of Mission, MSF, Belgium, expressed his fear that the adoption of the Ordinance in its current form would allow multinational drug companies to patent some of the AIDS drugs, thereby compelling Indian generic drug makers to stop its production.

According to experts, the compulsory license provision would not be of any help if India stops producing these drugs on a regular basis. "Many of the countries would be needing small quantities of AIDS drugs. Indian companies cannot suddenly manufacture these drugs. They need to be in the picture, to supply required quantities of formulations / bulk drugs to the world's poorest nations," they say.

Bill Haddad said that the UN Commission on Health, of which he is a member, had recognized TRIPS as a danger to the health and safety of the poor people of the world. It was in this context that he wanted the Central Government to go back from its attempt to introduce changes in the Patent Act without safeguarding the interests of the poor.

B K Keyla, convenor of National Group on Patent Law accused the government of having failed to make maximum use of the flexibility available within the TRIPS framework and has created total monopolies in medicine.

The representatives of Indian Drugs Manufacturers Association (IDMA) and Indian Pharmaceutical Alliance (IPA) expressed their serious concern over the Ordinance in its current form. The IPA secretary general D G Shah wanted the government to define "patentability" in clear terms to minimize the approval of fraudulent patents for drugs. The meeting was jointly organised by the Research Foundation of Science, Technology and Ecology, the National Group on Patent Law and the Transform India Group.