||

Working Group for the formulation of Tenth Five Year Plan (2002-2007)

Drugs and Pharmaceuticals

Dated 14th December 2001

Composition:

Terms of Reference :

1. To review the status of the industry including Ninth Plan targets, vis-à-vis achievements, in terms of production as well as exports, identify the reasons for major deviations, if any, bring out areas of strength and weakness of the Indian industry vis-à-vis international Drugs and Pharmaceuticals Industry.
2. To assess the structure of the drugs and pharmaceuticals industry and suggest measures to put the indigenous industry on a sound footing and capable of meeting the challenge of liberalisation and opening up of the economy.
3. To assess the present status of WHO-GMP (World Health Organisation -Good Manufacturing Practice) certification and suggest timeframe within which all manufacturers of drugs and pharmaceutical products in the country should obtain this certification.
4. To assess the present R and D status of the Drugs and Pharmaceuticals Industry and to suggest measures for upgradation including the role of the Government, Industry-Institutional linkages, investment (including foreign) both by Industry and the Government, etc., to make the drugs and pharmaceuticals industry internationally competitive and meet the emerging challenges arising out of the WTO-regime.
5. To assess the requirements of equipment/machinery and indigenous capability for fabrication of internationally competitive equipment and suggest measures for augmentation of capabilities, where necessary.
6. To assess the present employment and likely employment that wilt be created in the Drugs and Pharmaceuticals industry during trie Tenth Plan period and in the perspective of 15 years.
7. To assess the present training and development infrastructure of the Drugs and Pharmaceuticals Industry, of related areas and to suggest measures including institutional mechanisms to strengthen it, where required, including investment and sources of investment.
8. To review the implementation of the Drug Policy as well as Drug (Price Control) Order as envisaged in the Ninth Plan and suggest appropriate modifications in the liberalised environment and in particular measures to reduce the rigours of price controls especially where they have become counter-productive.
9. To assess the present regulatory mechanism and suggest changes/modifications as deemed necessary.
10. To review the present Drugs and Cosmetics Act and to suggest amendments to it including for ensuring GMP.
11. To review the present structure of the Indian Drugs Industry, price control mechanism and suggest measures for improving the quality of drugs, particularly for tackling the menace of spurious drugs.
12. To benchmark Indian drugs and pharmaceuticals industry against international drugs and pharmaceuticals industry and suggest appropriate measures for bringing it up to international level.
13. To make such other recommendations as are considered appropriate, to make the drugs and pharmaceuticals industry internationally competitive, at the earliest

The Working Group may co-opt such officials or non-official(s) as member of the Group as considered necessary. The Working Group may also constitute sub-group(s) if so desired.

The expenditure on TA/DA of official members in connection with the meetings of the Committee will borne by the parent Department/Ministry to which the official belongs. The non-official members of the Committee will be entitled to TA/DA as permissible to Grade I officers of the Government of India and this expenditure will be borne by the Planning Commission.

The Working Group will submit its report within six months.