The Bulk Drug Manufacturers Association (BDMA) has submitted its observations and comments on Draft National Pharmaceutical Policy 2006 to the Dept of Chemicals and Petrochemicals, Ministry of Chemicals & Fertilizers. BDMA welcomed the step to form National Drug Authority and Drugs and Therapeutics (NADT), leading to an integrated regulatory system in the country.

The government move to increase Pharmaceutical Research and Development Support Fund (PRDSF) of Rs 150 cr in a phased manner over the next five years is a welcome step. However, BDMA suggested that a part of this funds (Rs 20-25 crore) should be kept at the disposal of interested governments of states which have got substantial APIs / intermediates manufacturing activities.

To consider proposals and release of funds to individual units, such State Governments could constitute committees with members such as-principal secretary / secretary, Industries Department; nominee of CSIR, consortiums of Financial Institutions or concerned manufacturing Associations; professor of Pharmacy from a university in the particular state. Such a committee should be headed by a prominent scientist of international stature in pharmaceutical sciences / chemistry / chemical engineering etc.

An officer of NPPA should be designated to monitor the utilization of Pharmaceutical Research Development Support Fund and also to encourage the state governments to set up their own pharmaceuticals research and development funds.

The Association considered complete exemption of anti-HIV/AIDS drugs (bulk drugs as well as formulations) from the payment of excise duty, customs duty and other duties as a welcome step. Manufacturers of these drugs should be allowed normal profits as per the norms of NPPA, after estimating the cost of production and allowing profit margins. Trade margins of these drugs could be lowered, since they are directly purchased by the Government / NGOs.

In case any Indian company starts manufacture of second-generation drugs, which are presently imported, such an Indian company should be allowed to supply their products at the same prices at which these anti HIV / AIDS drugs are procured at negotiated prices from the concerned overseas manufacturers.

Policy, authorizing the government or designated authority to seek or compel disclosure of any information or data relevant to its functioning from all manufacturers, marketers, distributors or retailers of drugs and therapeutic products may also include production and sales data pertaining to bulk drugs / API's, as it is necessary to formulate any future Policy framework. In the absence of such data, any policy of Government would be a futile exercise, BDMA noted.

One of the major responsibilities given to NPPA is to render advice to the Central Government on changes or revisions in the drug policy. With this responsibility, NPPA should take the initiative to suggest for incorporation of such provisions in the drug policy to develop the basic infrastructure to aid and support the Indian Pharmaceutical Industry.

The Pharmaceutical Policy might actively consider creation and establishment of a separate department in NPPA / NADT for monitoring production, imports and exports of major pharmaceutical products of each medium, large and organized sector company.

The government should consider strengthening of NPPA / NADT in the areas of - Legal / Judicial matters; Technical / Chemical areas; Methodologies of costing; Consumer representations, etc. For this purpose NPPA should be provided with either an advisory body. For discharging enlarged responsibilities, NPPA / NADT should probably have regional offices at major centres of pharmaceutical industries. In addition to the above, NPPA should analyze the reasons for shortages of products and find ways and means to curtail or eliminate the shortages by encouraging the creation of additional capacities.

It is felt that cost of production of any drug manufactured by pharma PSUs may not be less than the cost of production of such drugs manufactured by private sector companies. This is due to abnormal overheads that a PSU incurs in its operation. Hence, the question of revival of sick PSUs should be thoroughly analyzed. However, existing Research and Development Centres of these units could be revived to help to conduct drug development including clinical trials, patent filing, upgradation of technology etc, with regard to all aspects of APIs and formulations and also to look into the generation of cleaner technologies to reduce and control pollution.

The decision of the government to entrust the responsibility of supervising Research Centre of IDPL at Hyderabad by NIPER is a welcome step. However, it would have been better if manufacturing associations like BDMA and IDMA were taken into confidence to define the objectives and activities of IDPL' s Research Centre at Hyderabad.

It is advised that such Research Centres of PSUs should be managed by independent Trusts / Registered Societies, which could include representatives / nominees of- Governments of States in which these Centres are located; State FDAs; Manufacturing associations like BDMA, IDMA etc; Council of Scientific & Industrial Research (CSIR) / DSIR; Head of such Trusts / Societies should be an eminent scientist of international stature.

It has welcomed the idea of Health Cess for funding Schemes for Poor, and also setting up new NIPER - like institutes on the lines similar to the IITs. Such institutes would serve as Centres of Excellence for Pharmaceutical Sciences.

With regard to Research and Development, extending fiscal incentives indicated in the draft policy to Companies (Gold Standard Companies) and the provisions made for these companies are positive.

It also welcomed the idea of development of Orphaned Drugs, Scheme of Interest Subsidy for implementation of Schedule M of Drugs and Cosmetics Rules for Good Manufacturing Practices and establishment of Pharma Parks / SEZs for Pharma Industry. It has suggested to designate an officer to advice various state governments to set-up pharma industry parks with shared utility and infrastructure facilities.