NKDPMA welcomes extension of Schedule M deadline, seek dilution of norms
North Karnataka Drugs and Pharmaceutical Manufacturers Association (NKDPMA) welcomed the government's decision to extend the deadline for Schedule M by another six months. A major grievance among the NKDPMA members was the stringent norms of the revised Schedule M, which was quite tough on the small-scale sector in the state.
Although Ramanand Hegde, president, North Karnataka Drugs and Pharmaceutical Manufacturers Association commended the Union Government's decision to extend the deadline for Schedule M by another six months, he pointed out that the revised Schedule M was biased against the small scale sector. "There is an urgent need for SSI representation in the technical committee, which formulates the revised Schedule M," he commented.
“We are not against Schedule M but are asking for a simplification of the prescribed norms. The Schedule M is not relevant to Indian scenario and is in tune with WHO GMP standards. It is impossible for small units to achieve these standards with the investments ranging from Rs 50 lakh to Rs 1 crore," he added.
Out of the total number of 25 units in Bidar, Gulbarga, Raichur, Bellary, Koppal, Bagalkot, Bijapur, Belgaum, Hubli and Dharwad in the north Karnataka region, 95 per cent were SSIs. The units in the region were demanding for an extension of Schedule M deadline so that they could be totally compliant to face the onslaught of competition and also offer their units for contract manufacture to domestic customers. The units in the region have raised funds for upgradation. Out of the 25 units in the northern districts of the state, almost 80 per cent are getting ready for Schedule M compliance and the extension has come as a breather, added Hegde.