While another year has also gone by, several important files on policies and regulations related to pharma industry are stuck at various government departments, thanks to the snail's pace at which the government takes decisions. And with the general elections round the corner, there is no hope of an early decision by government on these important issues.
Among the pending issues that have become victims to the red tapism in the government, the industry is keenly watching a decision on the national pharmaceutical policy. The policy has been pending since 2002, after 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 GoM in January 2007. But, even after more than seven months of the last meeting on April 30, there is no proposal with the Department of Pharmaceuticals to hold the next meeting of the GoM headed by Union agriculture minister Sharad Pawar.
Senior officials in the pharma department said that as of now there is no proposal from Pawar's office to hold the next GoM meeting on pharma policy which has been pending for several years. "Given the hectic political activities in the national capital, it appears that the policy may not see the light of the day before the next government," a senior pharma department official involved in the policy matters said.
The case of the formulation of a policy on data exclusivity, which has been pending since 2004, is also not much different as the issue is learnt to have been put in the cold storage, at least for the time being, by the union health ministry. 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. But, there has been no meaningful dialogue on the issue for the last several months and a discussion on the issue is not in the agenda of the ministry for the immediate future.
Another policy that has been stuck with the government is the HIV/AIDS Bill 2006 which is pending with the Union law ministry. According to sources, the Bill sent to law ministry in September 2007 has been returned to the health ministry with substantial changes. Now, after studying the changes, the health ministry will send the Bill to the law ministry again and a decision is not in sight.
The story of the CDA Bill is also not different. Even though the health ministry wanted a decision on this Bill, it became a casualty to the on-going simmering political war of words between the treasury and opposition benches in Parliament arising out of Union minority welfare minister AR Antulay's controversial statement on the death of former ATF chief Hemant Karkare. Now, that the winter session of Parliament has come to end, and the possibility of another full-fledged session during the tenure of this government as good as nil, the fate of this much awaited Bill will be decided by the next government.
The Najma Heptulla committee report on the impact of the implementation of revised Schedule M on small scale drug units has also become a casualty to the political storm created by AR Antulay's controversial statement. Though the committee, constituted over two years ago, is learnt to have finalized the report, it could not submit the report due to the political development.