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Major policy initiatives for pharma industry stuck at various govt depts with no decisions
Joseph Alexander, New Delhi | Monday, January 14, 2008, 08:00 Hrs  [IST]

With another year passed by, all files relating to key policies and regulations for the pharmaceutical sector are stuck in the cabinets of various ministries of the Central government with no decision taken. Most of them are likely to get further dustier under the red tapes in the current as well.

Leading the pack of pending policies is national Pharmaceutical Policy 2006, two years behind the schedule already. There are no indications of calling the third meeting of the Group of Ministers on the much-awaited pharmaceutical policy. With some ministers and key officials concerned going out of the capital on longer periods, the meeting is unlikely to take place for an indefinite period, according to sources.

``Just forget about it for the time being,'' an official said. As Agriculture Minister Sharad Pawar is heading the seven-member panel, his ministry has to coordinate and fix the date. Moreover, as Pawar being the head of BCCI , he is more busy with his cricketing duties.

The policy, in fact has been pending since 2002, after Pharmaceutical Policy 2002 was aborted. After many committees and reports, as usual with Government procedures, a final draft was submitted in November 2006 and the Cabinet referred the draft policy to GoM on January 11, 2007. The first meeting of the GoM was held in April and the second in September. Since then, the industry has been waiting for the third meeting of the panel. Even if the panel finalises it in third or fourth meeting, its report has to go back to the Cabinet for approval, which means more time before it comes into effect. Time is running out for Chemicals Minister Ram Vilas Paswan to see his favourite document getting implemented, as the present coalition has little over one year left in the office.

So is the case with eagerly-awaited policy on data exclusivity, pending since 2004. Little progress has been made after the Satwant Reddy panel hurriedly submitted the recommendations in May last year. Only one meeting has been held between the different departments during the last seven months. The department of Chemicals and Petrochemicals set up the high-level inter-ministerial consultative committee in February 2004 under the chairmanship of then secretary Satwant Reddy.

Sources said no further meeting is scheduled soon on the matter as the health ministry had been asked to hold discussions with all stake-holders before proposing the necessary amendments to the Drugs and Cosmetics Act and rules in accordance with the data exclusivity policy.

The effort to streamline the pharmaceutical sector with a centralized regulatory system has also been pending since 2003, when the Mashelkar Committee submitted its final recommendations in this regard. Though a bill was introduced in August to constitute Central Drug Authority of India on the lines of US FDA, it was now under the consideration of the Parliamentary Standing Committee on Health and Family Welfare. The health minister says that it will be passed during the budget session but officials note that it would be nearly impossible.

The claims and talks by the authorities on separate bills on spurious drugs and clinical trials, AIDS bill, committees on negotiating drugs prices of patented drugs, panel on health insurance, the GoM on the Rs 441-crore revival package for IDPL, the TEG (Mashelkar Committee) on patent issues, etc. grew older by another year without making any step forward.

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