The small scale pharma units in the country have urged Prime Minister Dr Manmohan Singh to transfer all the regulatory powers related to pharma industry from the ministry of health to department of pharmaceuticals (DOP) as the lack of coordination between these two departments are creating several avoidable problems to the industry.

In a letter to the prime minister, SME Pharma Industries Confederation (SPIC) said that even though many problems have been solved by creating an independent DOP in the Ministry of Chemicals and Fertilizers, it has been noticed that the hands of the DOP are tied due to the lack of coordination between the ministries.

For instance, SPIC said, the Najma Heptullah recommendations on Schedule M have taken a serious view of closure of SSI Units at the same time desired implementation of Schedule M. This is possible only if relaxations are provided from unreasonable clauses. Hundreds of SSI were closed down in the country. SSI is under tremendous pressure to comply the Schedule M without any technical and financial support which should have been first arranged before Schedule M implementation. This could only happen if DOP was in charge of Regulatory. Presently it can only react to situations created. It was helpless when SSIs were closed down.

Besides one hand of the government rarely knows what the other is doing. Instances are levy of anomalous MRP excise and implementation of Schedule M. Both problems are four years old but refuse to go away. The SSI exemption limit continues to be truncated though stimulus provides relief from magnified disparity.

Schedule M of Drugs Act was amended at Secretary Level in 2001 and implemented in 2005. But it has been impossible to implement even in 2009. Just recently, the very Department that brought in Schedule M had to close down three of its own Vaccine PSUs four years after implementation because of non-compliance despite abundant funds available with the government. Hence, the question of SSI complying without any relaxation in Schedule M and funding is out of question. For this DOP has to coordinate with two other Departments (health and finance) which is time consuming, SPIC pleaded.

"Several such issues shall haunt the SSI industry and the DOP with limited powers shall be helpless unless Regulatory department is merged with it. Hence we request merger with the DOP since it is a full fledged department now. It will go a long way in solving problems of industry as well as the consumer in providing affordable drugs to the common man," SPIC letter said.