| A letter to the prime minister on the issue, sent last week, was prompted by renewed pressure on India from developed countries like the United States to move ahead on the issue of data protection as required under the trade related intellectual property rights (TRIPS) agreement. |
| Article 39.3 of the agreement requires member nations to protect the undisclosed test data submitted for marketing authorisation from unfair commercial use. |
| "The department of chemicals and petrochemicals is still of the view that there should be data exclusivity rather than data protection. The stance of the commerce ministry is that data exclusivity is much more than what is required under TRIPS, hence it should be resorted to only in case a specific sector seeks it," a government official said. |
| The main difference between data protection and exclusivity is that in the case of the former, data pertaining to a clinical trial of a chemical is kept with the controlling authority but if a second company desires to use the same chemical and methodology to conduct a similar clinical trial, the authority uses the details of the first trial if it was not successful. As regards data exclusivity, the data cannot be used in any circumstance. |
| "Since India is a developing country, we cannot afford to waste our precious resources. Also, since India has already amended the patent laws, merely introducing guidelines for data protection should not be delayed as it sends a negative signal to developed countries ," the official said. |
| Nath has already written three letters to Ram Vilas Paswan and the Ministry for Chemicals and Fertilisers, which is spearheading the formation of guidelines. The ministry had set up a committee two years ago but it is yet to finalise the guidelines. |
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