Departments of Health and Pharmaceuticals have launched a process to introduce quality mark for the generic drugs by starting consultation with the stakeholders on the proposal. The industry, however, does not appear to be very happy with the move.

A jointly held meeting by both the departments recently saw the leading pharma associations raising apprehensions about the proposal. The associations felt that it would not make much difference and cannot bring in any desired goal of further improving the quality of drugs in the country. Leaders of different associations attended the meeting, called by the pharma department.

As the first step, the departments are planning to introduce a logo of quality for those drugs under price control and produced by GMP compliant units. Later, it would cover the entire spectrum of generic drugs in the country. The logo, on the lines of ISI mark or Agmark for other goods, would help the consumers to distinguish between quality and sub-standard drugs. Necessary changes will be made in the Drugs and Cosmetics Act to ensure a provision in this regard, after more consultations, sources said.

The idea of introducing a quality mark for generic medicines was mooted by the Pronab Sen Committee as a number of small-scale pharmaceutical units have started manufacturing such drugs. The idea was also supported by the Planning Commission in its recommendations for the 11th Five-Year Plan that ends in 2012. It was also included in the pending pharmaceutical policy.

However, the associations felt that it would not do any good in fact. SME Pharma Industries Confederation (SPIC) objected the idea because logo would come at a cost which SMEs may not be in a position to afford. Besides, the cost should be taken into account by NPPA while working out the MRP. "Any effort to provide logo for quality alone without the drug being affordable would be an invitation to spurious and fake drug production. As in the case of currency, the normal practice is to produce counterfeit drugs of costly medicines. Currency note of Rs 500 is counterfeited, not that Rs 10," SPIC representatives argued at the meeting.

The senior officials from the CDSCO who attended the meeting called for better and more effective coordination between the departments of pharma and health as regulatory and quality aspects are with the health while pricing is done by the NPPA under the DoP. The quality and price are inter-related and both the departments should work closer, they suggested.