The Parliamentary Committee to study the issues of SSI drug makers, especially the woes arising out of complying with the revised GMP under Schedule M, is likely to submit its report sometime in the next month after visiting some units in different parts of the country.
The Subordinate Legislation Committee, headed by A Vijayaraghavan, MP, has already visited some SSI manufacturing units in the North and would visit Tamil Nadu and Kerala from January 1, 2007 in their Southern leg of inspection. The panel is likely to submit the report after concluding the visits.
The 18-member committee will meet the representatives of the industry, health officials, drug controller besides personally taking stocks of the situation of the units in Chennai and Thiruvananthapuram. The committee will go around a number of units, which have spent huge amounts to comply with the norms, sources said.
The small units, facing closure due to heavy additional investments for complying with the norms of Schedule M, are seeking another year of extension beyond March 31, 2007, the present deadline set by the Government.
More than 50 per cent of the 240 units in Tamil Nadu alone will have to close down if extension was not given, CIPI president T S Jayasankar told Pharmabiz. The industry body has prepared a memorandum detailing the problems, to be submitted to the visiting panel.
It is reported that over 700 of the total of 4176 registered small-scale drug makers in the country have either closed down or in the verge of the same, following the revised norms. The licences of 337 units have either been suspended or found closed so far.
``All adversities have come upon us simultaneously. We are for ensuring quality, but we want to have more time to comply with the norms and want to go ahead in phases, as it requires additional investments. We also are looking for a clear definition of small scale and medium scale,'' Jayasankar said.
This is unwarranted and it would only give chances to the officials to find faults with and harass the small players. It should be made mandatory based on capabilities, instead of bracketing the entire small-scale sector, he said.
According to latest reports, as many as 1672 units have upgraded facilities as per the Schedule M while nearly 1800 others are in the process of doing the same.