Mumbai, Dec. 28: The Centre may remove some of the grey areas under which compulsory licensing may be invoked in the Patent (Amendment) Bill 2003 that was recently introduced in Parliament by minister of commerce and law and justice Arun Jaitley.

Compulsory licences allow generic companies to produce a drug that is even patented for meeting public health requirements arising from an emergency or a crisis. The bill is planning to introduce a provision for granting compulsory licence for export of medicines to countries which do not have manufacturing facilities to deal with an emergency or crisis involving public health.

Sources said the amendment, coming ahead of the deadline to usher in the product patent regime, may result in the government being more specific about various scenarios under which such a measure would be invoked, thus removing any ambiguity pertaining to the definition of public health emergency.

The definition had become a contentious issue earlier this year when the US was isolated regarding this at the WTO meetings. The country had then also raised its concern on what conditions could trigger compulsory licensing.

However, in a significant deal in August, the WTO approved a deal which would enable a supply of drugs to developing countries in times of crisis.

Even as the accord opened up new markets for Indian companies, it left a section of the domestic pharma industry disappointed as it specified certain changes in colour, size and shapes of the affordable medicines from its original patented product. Analysts then said this provision would lead to increased costs of the product, thus making it a non-profitable proposition.

Multinational pharmaceutical companies have been seeking more clarity from the government on compulsory licensing to prevent their misuse.