Trouble looms for local generic drug makers

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Trouble looms for local generic makers

Published: Friday, Nov 19, 2010, 3:56 IST

By Priyanka Golikeri | Place: Mumbai | Agency: DNA

India's coveted perch as the top supplier of generic medicines is under threat.

The European Union, Japan, the United States, Canada as well as developing

nations such as Mexico have nearly concluded an agreement that could seriously

undermine the country's ability to supply low-cost off-patent medicines to the

world's poor.

Indeed, should the Anti-Counterfeiting Trade Agreement (ACTA), the draft text of

which was released this week, pass muster, violations of intellectual property

(IP) will become a criminal offence in those countries.

Going by industry experts, the agreement permits seizure and destruction of

generic medicines on the mere assumption that they look similar to the innovator

product.

" Generic companies may even face criminal proceedings merely on the basis of an

allegation of infringing a patent or trademark, " said a Mumbai-based IP expert.

A lawyer working in the area of access to medicines explained the likely

difficulties for an exporter: " Say a generic AIDS medicine by X company in India

has been shipped to a patient in Mexico by a patient group. Now if someone

alleges that this AIDS medicine violates either trademark or patent of the

innovator product, then along with the X company, the patient group and the

patient can get pulled to court. "

" They can face severe penalty and imprisonment, " said Dr Unni Karunakara,

international council president, Medecins Sans Frontieres, an international

humanitarian organisation, which buys over 80% of its AIDS medicines and 25% of

its antibiotics and TB/malaria medicines from India for supply in poor

countries.

" This reduces the viability of generic production as companies will feel

threatened to manufacture and supply generics, " said a Mumbai-based IP expert.

Those manufacturing generic medicines will be hit hard for sure.

But it would be a harder blow for poor people the world over who depend on

medicine supplies from India as they cannot afford the exorbitantly priced

medicines sold by innovator MNCs.

" The agreement can severely affect supply of low-cost generics from

India and keep several poor patients who can't afford expensive innovator

medicines without treatment, " said the lawyer.

As per the Journal of International AIDS Society, between 2002 and 2008, over 4

million people in sub-Saharan Africa and Latin America were treated with

low-cost HIV/AIDS medicines made in India.

According to DG Shah, secretary general of Indian Pharmaceutical Alliance, ACTA

is a much more serious issue than the seizure of more than 17 consignments of

legitimate Indian generic medicines by customs officials in The Netherlands and

Germany last year.

Yet, " India can't do anything now except indicate its displeasure. "

Experts see ACTA protecting the commercial interests of companies at the cost of

the patients.

" Instead, action against unsafe medicines should be developed through a

legitimate process involving all countries and not just among a few countries

negotiating in secret, " said Dr Karunakara.

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