Indian Pharmaceutical Alliance (IPA), in a proposal, has urged upgradation of country's regulatory infrastructure to make the domestic pharmaceutical industry competitive in the post 2005 era. According to D.G.Shah, secretary general of the IPA, with 11 research based pharmaceutical companies as members, there is a need to establish separate standards for both the Active Pharmaceutical Ingredients (APIs) and finished dosage forms that will have to be reviewed from time to time. IPA has also called for the supplier to be brought under the standards purview to ensure quality.

Shah said that India should harmonise standards for registration of new drugs and sources of supply with those of the regulated markets. He maintained that there should be equal fee hike and be made uniform to all.

The proposal, being finalized, will be taken up for discussion at the forthcoming meeting of various associations representing the chemicals, petrochemical and pharmaceutical industries next month. The proposal is also seeking to specify the time for evaluation of the results by the concerned authority beyond which the applicant will be deemed to have been granted approval for the next phase.

"Such a guideline is very important in the present context and in the regime of a product patent as delays in processing will erode the patent life of a product. IPA also intends to bring up the issue of the urgent need to develop, notify and implement clear guidelines for all stages of clinical trials," Shah maintained, stating further that in order to do so the patent offices must be upgraded at the earliest. "The state of the patent offices and the understanding of the modern patent systems is very poor in the country. This area requires immediate attention and action," Shah maintained.