The Hindu Business Line : PMO working on pharma policy

According to a note prepared by the Planning Commission Chairman, Mr Montek Singh Ahluwalia, and forwarded by the PMO to various other Ministries for comments, it has been proposed that policies must support the domestic industry to expand presence in the global markets, give a fillip to R&D, and attract MNCs so that they shift research to India.

Official sources said that the Government is seeking views on formulating a new drug price control order (DPCO) to rationalise price control of drugs, steps to strengthen the data protection regime for data generated from clinical trials conducted in India, and tax sops for R&D activities.

It has also sought suggestions on the setting up of a Central Drug Regulatory Authority to combat the menace of spurious drugs and ensure that the country is TRIPS-compliant.

A committee under the Planning Commission Advisor, Dr Pronab Sen, is already examining the issue of pricing of drugs.

On the issue of intellectual property rights, Mr Ahluwalia has said that India must be TRIPS-compliant (which is the minimal standard).

"There is no compelling need to be TRIPS plus currently and in any case it is not politically feasible. However, we must keep in mind that we need to move in this direction in future, as we reach the next stage of maturity in the industry," the note said.

Referring to the Committee under the CSIR Chief, Dr R.A. Mashelkar, which is examining certain aspects of the Third Amendment to the Patents Bill, the note said: "We must ensure that we are not forced to bring amendments which make us TRIPS minus."

For instance, the clause pertaining to payment of reasonable royalty by generic companies to the patent-holder once the mail box is opened and exclusive marketing rights are granted is a cause for concern.

"If the Mashelkar Committee concludes that the provision is inconsistent with TRIPS, there will be demands especially from the US to amend the Act.

And if we do not do so, the matter may be referred to the dispute resolution in the WTO," said sources.

On data exclusivity, Mr Ahluwalia has said that it is essential to attract clinical trials to India, for which "effective protection" must be provided.

A committee under the Ministry of Chemicals and Fertilisers is finalising a report. However, the sources said that international practices must be examined before taking a decision.

"China, Brazil, and other countries that see themselves as potential players in the global pharmaceutical market have provided data protection. We will look into those as well," they added.

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