Bulk Drug Manufacturers Association (BDMA) has expressed anguish over the delay in the announcement of the new Drugs Price Control Order (DPCO) and the implementation of the new pharma policy. The Association felt that the NPPA's move to review price control on non-scheduled formulations would be a big blow to the pharma industry.
In a recent representation made to National Pharmaceutical Pricing Authority (NPPA), Venkat Jasti, president BDMA urged the government to announce the liberalized DPCO on the lines indicated in the "Pharmaceutical Policy 2002". According to him, any step that goes against the spirit of liberalization would be retrogressive 'inflicting serious damage to the ailing pharmaceutical units in small, medium and bulk drug sectors and crippling it further in this demoralizing economic and climatic scenario, especially in the background of the recent negative international developments'.
The Association felt that the government should have overcome or circumvented all judicial interventions that have delayed the announcement of the policy. The representation asked the authority to incorporate all previously agreed facts while announcing the new DPCO.
BDMA reminded NPPA that the government has in principle agreed that the 'price fixation of bulk drugs is no more relevant'. The association wanted to ensure that there should be no fixation of price for bulk drugs. It also hoped that the new DPCO would bring down the list of scheduled drugs under price control and reduces the span of price control substantially.
The Association wanted NPPA to ensure that the details of cost for all non-scheduled drugs to be submitted in Form-II are deleted in the new DPCO. Deletion of the imposition of condition to sell bulk drugs to others, announcement of special incentives to encourage cGMP standards upgradation to WHO/International ICH standards, USFDA/MCA/TGA Approvals/Registrations, ICH/CTD (Common Technical Document) - International standards, International Regulatory Approvals, DST approved R&D Innovative Research and Patents - Indian/International/PCT were all expected by the industry in the new policy, BDMA said.
The Association wanted the new DPCO to provide for incremental increase in Maximum Allowable Post-Manufacturing Expenses (MAPE) to cGMP, ICH, CTD, USFDA, MCA, TGA, DST-R&D, Patents, Exports etc. Special exemption from DPCO to R&D based pharma companies was also requested.