Key changes sought include the replacement of the current system of price control by a transparent system of macro management, clear guidelines for all stages of clinical trials, appropriate guidelines to handle exclusive marketing rights (EMR) applications, dismantling of industrial licensing and import trade controls and automatic approval for foreign technology agreements. Key IPA members include Ranbaxy Labs, Cipla, Dr Reddy's Labs, Nicholas Piramal and Sun Pharma, among others.

Significantly, the IPA has, in a letter to the minister for chemicals and fertilisers Sunderlal Patwa, offered to bear the burden of a subsidy estimated to exceed Rs 500 crore. This "cross subsidy" is aimed at allowing the poor access modern medicines, IPA secretary general DG Shah said.In an elaborate document, IPA has suggested enlarging the scope of the sarvapriya scheme to include the supply of essential drugs through the public distribution system. "These drugs under the PDS may form part of a basket of new items such as tea, toothpaste, notebooks etc. being offered under the sarvapriya scheme and may be dispensed from Primary Health Centres," the IPA said.

The industry body has also laid down that the criteria for inclusion of a drug under the price management regime be defined as: drug molecules with an annual turnover (including combinations) of less than Rs 40 crore, wherein there is a monopoly and; drug molecules with an annual turnover in excess of Rs 40 crore where there is inadequate competition. "The exercise of identification and review of the list of price controlled drugs be undertaken every five years from the year in which it is first done," it says. Besides, the cost plus formula for pricing has pushed quality parameters to the lowest denominator, penalising good manufacturing practices (GMP).

However, on the issue of FDI in the pharma sector, the IPA says that investment above 74 per cent should be considered on a case-by-case basis. "The current tendency of permitting 100 per cent subsidiaries without investment in manufacturing or bringing new technology must be reviewed and curbed," the IPA advocates.

On formulating specific guidelines for clinical trials for new chemical entities, the IPA says that these rules should specify the time period for evaluation of the results by the concerned authority, beyond which the applicant will be deemed to have granted approval for the next phase. "This is particularly important in the regime of product patents, as processing delays will erode the patent life of a product," the industry body says.

Officials' retirement to add to industry's woes
Anju GhangurdeINDIA Pharma Inc may find itself orphaned as it moves towards the close of calendar 2000, with several key government officials in the sector headed for retirement.

Industry sources claim that chairman of the National Pharmaceutical Pricing Authority (NPPA) Arun Kumar and secretary (ministry of chemicals and petrochemicals) Arvind Varma are due to call it a day over the next few months. "We already have a new minister at this crucial juncture. The drug policy is yet to be announced. Critical areas will see new faces. Such uncertainties are an impediment to the future of the domestic industry," sources said. Indications are that new member secretary at the NPPA may also not have a long tenure at the apex pricing authority, adding to woes of industry.