The Working Group on Drugs and Pharmaceuticals for 11th Plan (2007-2012) constituted by the Planning Commission has formed three sub-groups to give specific attention to issues related to R&D, regulatory structure and structure of industry. The sub-groups have been asked to submit their reports within three weeks.

The sub-groups have already convened their first round of meetings, and the next one is to take place soon. The prime task of the group is to review the status of the industry including 10th Plan projects vis-à-vis achievements and suggest a blue print for the growth of the industry in the next five years.

The Working Group has been asked to review the status in terms of production as well as exports, identify the reasons for major deviations and bring out the strength and weakness of Indian industry vis-à-vis international drugs and pharmaceutical industry. The group is to submit its report by October.

The working group consists of representatives from all related ministries, directors of premier drug institutes, industry association representatives and chairmen of Dr Reddy Laboratories, Ranbaxy Laboratories and Cipla Limited. The working group is to assess the present regulatory mechanism and the need for an apex authority to control price, quality and supply of drugs.

The terms of reference of the working group include assessment of the strengths and capabilities of domestic pharmaceutical industry in the light of the new IPR regime, identify emerging areas having specific potential for growth and competitiveness and suggest measures for putting the indigenous industry on sound footing. The present status of WHO GMP certification and level of Schedule M compliance would be studied.

The group will assess the R & D status and suggest measures to increase the role of the industry R&D, industry institutional linkages, investment (including foreign) to make drugs competitive in WTO regime. Requirement of equipment and machinery and need for enhancing indigenous capability for fabrication of internationally competitive equipment is another area of focus. Human resources development in pharmaceutical sector would be discussed in a long term (15 year) perspective. Assessment of the present educational and training facilities and infrastructure for human resource development to suggest measures including institutional mechanisms to strengthen it would also be part of its agenda.

The revival of PSUs, critical review of Drugs and Cosmetics Act, enhance of quality of drugs, improvement of accessibility of essential medicines for common man and National Health Policy have also been included among the terms of reference of the group.

The 24 members of the working group are Secretary, Department of Chemicals and Petrochemicals (chairman of the group), Secretary DSIR, advisors from Planning Commission, representatives from ministries of health, science & technology and biotechnology, Central Drugs Research Institute, National Institute for Pharmaceutical Education and Research, Pharmexcil, Indian Pharmaceutical Alliance, Organisation of Pharmaceutical Producers of India, Indian Drugs Manufacturers Association, Confederation of Indian Pharmaceutical Industries (SSI), Bulk Drugs Manufacturers Association etc are members.