The Najma Heptulla committee, constituted over two years ago to study the impact of the implementation of revised Schedule M on small scale drug units in the country, will table its findings in Parliament in a day or two. The committee's findings will be a key factor in shaping further implementation of revised Schedule M in the country.
"Dr Najma Heptulla-led committee has finalized its report and it will be tabled in the on-going session of Parliament very soon, in a day or two," a senior official involved in charting the report said. However, he refused to divulge any further details.
However, sources said that the Dr Najma Heptulla-led committee, which had undertaken field visits to different parts of the country and held several rounds of meetings with the industry representatives to get the firsthand information on the impact of the revised Schedule M on small scale industries, has incorporated several features in its report which will go in favour of the small and medium drugs units to implement the Schedule M norms.
The industry is eagerly waiting for the Najma committee's findings because the findings will have a far-reaching impact on it, especially the small and medium players. After the implementation of revised schedule M in the year 2005, thousands of small pharma units across the country had no other option but to close down their shops due to the financial problems. Though the government's intention by revising the Schedule M was to enhance the standard of drug manufacturing to ensure maximum efficacy and safety of medicines, thousands of SSIs had to shut down their units since then as they were incapable of modernizing their manufacturing facilities due to high cost involved in the exercise.
The committee is learnt to have recommended a host of flexibilities including relaxation on space stipulation and air handling units (AHU). Relaxation on space stipulation, air handling units (AHU), etc will prove to be big relief to the SSIs as these were some of the major hurdles coming in the way of Schedule M implementation by the SSIs.