Pharmabiz
 

Data exclusivity report may be finalized by May end as Satwant Reddy retires

Joseph Alexander, New DelhiFriday, May 18, 2007, 08:00 Hrs  [IST]

With Chemicals & Fertilisers Secretary Satwant Reddy, who is heading inter-ministerial panel to frame the report on data exclusivity, is slated to retire by the end of this month, industry associations and pharma companies are a worried lot. Every effort is being made by them to ensure that industry's interests were not sacrificed in haste. "The last thing we want at this juncture is a half-baked report, cobbled up in a hurry. There is possibility of submitting the report before the committee chairperson retires,'' said a spokesman of the leading pharma association. However, official sources remained non-committal still on the fate of the report, which has been long overdue and was reportedly delayed following the controversy over Dr R A Mashelkar Committee report on patent law issues. Association leaders are frantically trying to make sure that report is not prepared in a hurry ahead of Reddy's retirement and does not harm the interests of the industry. The inter-ministerial committee for protection of undisclosed information under Article 39.3 of TRIPS agreement under the chairpersonship Reddy had already taken the views of most of the concerned groups and parties. And it can be finalized anytime. However, there were also indications that the outgoing Secretary still felt that time was not ripe to spell out the terms of data exclusivity. More over, the Government also does not want another controversy by granting data exclusivity, a demand by the pharma players to check arrival of copycat versions of patented drugs. It is also reported that the panel, after hearing views of different parties, still could not ensure consensus. The Health Ministry is also against granting data exclusivity, while the Commerce Ministry favoured it firmly. Even if the present panel finalises the report this month, it is likely to put on record all the divergent views by the different groups and ministries and adopt a middle-path by recommending data exclusivity for five years with sufficient in-built safeguards and excluding export of drugs.

 
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