The Alathur Pharmaceutical Manufacturers Association (APMA) has appealed the Central Government to centralise operations of various pharmaceutical regulatory agencies like the CDSCO, NPPA and other related departments under the health ministry, instead of different agencies governing the pharma industry under various ministries.

At present, the control of departments related to pharmaceutical industry is under different ministries and this situation causes various problems while implementing various policies. The industry has to shuttle between various ministries and departments for various approvals. The situation creates lot of confusion to the industry, S Lakshminarayanan, secretary, APMA told Pharmabiz.

In its pre-budget memorandum to the minister of small industries with suggestions of APMA to protect SSI pharma industries, the association pointed out that the government should frame policies supporting the domestic industries, especially the small scale units than helping the multinational companies. The NPPA should not fix prices arbitrarily and should not restrict it based on the working cost of multinationals. Similarly, the excise duty exemption limit for SSIs should be increased.

The implementation of Schedule M should be decided under the requirements of Indian conditions and should be under clear definitions, he said.

The excise duty, which is calculated with an abatement of 40% of MRP, may be raised to 50% and the MRP should be assessed on trade price and trade discount given or on factory based working cost arrived at. The memorandum pointed out that the value of samples cleared should not be taken into consideration for total aggregate clearance of Rs 1 crore, as the value of samples is not a sale value.

The association also suggested that a separate budget should be earmarked for the government purchase, both at the Central And State Government level. A policy should be framed to mandate atleast 60% of the government purchase of medicines that is done from the SSI units. Steps should be taken to provide an upgradation fund for SSI sector with repayment period of 10 years against the security of factory building etc. Implementation of fringe benefit tax should be reconsidered and should be classified under the turn over clause for SSI units, since the difference in marketing expense of SSI and MNC is huge, says the letter.