The small scale drug units who have been surviving on some of the fixed dose combination (FDC) drugs over the years are likely to face hard time as the authorities are now planning to include many of them as new drugs and give licences to those coming with scientific data.

Already on a losing ground due to the expected delay over the clearance of the remaining 156 FDCs out of the contentious 294 FDCs listed by the former DCGI, the small scale units may lose the right to their daily bread to big companies who are better placed to get approval for other FDCs as new drugs in future.

There are thousands of FDCs in the market and most of the small scale units have been manufacturing them as their mainstay business. However, the DCGI is learnt to have favoured listing them as new drugs if some companies come up for licence with required data and money. This has placed SME sector on a receiving end as many of them are not in a position to spend much on getting licences for their FDCs as new drugs, industry sources pointed out.

"We have spent lots of money and efforts to build markets for many combination drugs. If they are going to be bracketed as new drugs, the big companies are going to take them away from our hands obviously," said a leader of SME Pharma Industries Confederation (SPIC).

Reacting to the proposal, CIPI chairman T S Jaishankar said there was still lots of confusion about the fate of FDCs. "If these non-294 FDCs are going to be listed as new drugs, of course the small scale sector will suffer as it is not financially viable for many to get licences for new drugs," he said.

Already the delay expected for the clearance of the 156 FDCs has caused concern for the small scale sector. The expert panel headed by DCGI, following the recent meeting between the authorities and the industry over the vexed issue, is likely to come up with recommendations on the rationality of these drugs only by 2010. The panel will be meeting to assess the rationality of drugs in batches and the last meeting is to be held only in November 2009. Many of the units, especially those outside the excise-free zones, cannot get the licenses renewed from the SLAs now. Those in the excise-free zones alone will be left with licences for manufacturing these FDCs as they had secured licences for them only a couple of years ago, just before the issue and ban came up, and they have still two years to go for renewal.

Already the pharma industry had raised concern against the DCGI decision to include diclofenac+paracetamol combination in the list of new drugs. The SLAs cannot provide licences to new drugs for four years and the companies have to approach the DCGI office for the same as per the procedure.