Year 2009: A period of inaction in policy matters relating to pharma healthcareYet another year has also gone by. But the issues related to pharma and health sectors remain mostly unresolved, thanks to the lackadaisical manner in which the government looks at these issues. Several crucial files regarding policies and regulations related to these sectors are still stuck at various government departments with no sign of immediate disposal. The only silver lining on the otherwise gloomy horizon was the introduction of 'Transplantation of Human Organs Act, 1994' in Parliament at the fag end of the last session of Parliament.

Some of the major issues which have been eluding a decision for quite long time are the national pharmaceutical policy, policy on data exclusivity and a final decision on CDA formation. Besides, there are several important Bills which have also been waiting in the wings as these bills could not be introduced in Parliament because they are stuck in the bureaucratic red-tapism at different levels.

The national pharmaceutical policy has been pending since 2002, after draft Pharmaceutical Policy 2002 was aborted. After many committees and reports, a final draft was submitted in November 2006 and the prime minister eventually referred the draft policy to a GoM headed by union agriculture minister Sharad Pawar in January 2007.

But even after two years, the GoM could not take a decision on the issue and the issue was left to the next government in May this year. Once again, the Congress party formed government at the centre and Pawar was again asked to head the GoM on Pharma Policy. Since then, nobody had heard anything about the policy.

Not much different is the story of the data exclusivity issue which has been pending since 2004. The Satwant Reddy panel, constituted by the government in February 2004 to frame a government policy on data exclusivity issue, submitted its report on May 31, 2007. The panel, set up to decide on the protection of undisclosed information under Article 39.3 of TRIPS Agreement, suggested five year data exclusivity for pharmaceuticals with a number of safeguards. Though the union health ministry held some routine meetings on the issue, a final decision is still awaited.

The story of the formation of a Central Drug Authority (CDA) is also not different. While the industry is vertically split on the CDA issue, the government has been dilly dallying on the issue for some time. Though former union health minister Dr Ramadoss was all for the formation CDA, his successor is yet to publicly announce his stand on the issue. Though the union health ministry had recently sought suggestions from the state governments on the issue, the intention of the union government is not clear whether to scuttle the plan to form CDA or to revive it.

Besides, a string of Bills like NBRA Bill, HIV/AIDS Bill, Ethical Guidelines for Biomedical Research on Human Subjects Bill, ART Bill, Clinical Establishments Bill, etc, have been pending with the government for quite some time.