More than two years after its constitution to study impact of the implementation of revised Schedule M on small scale pharma units in the country, Najma Heptulla committee has finally tabled its recommendations in the just concluded session of Parliament.

Though the exact recommendations of the panel could not be accessed, it is learnt that the committee has recommended a host of flexibilities including relaxation on space stipulation and air handling units (AHU). Relaxation on space stipulation, 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.

But, the Parliament did not take up the report for discussion due to shortage of time. The Parliament session which commenced on February 12 ended on February 26 after completing the discussions on financial related issues including vote-on-account.

In fact, the Heptulla committee was to table the report in the winter session of Parliament in December last year. But the committee could not push through the issue to the Parliament due to the political chaos created by Union minority welfare minister AR Antulay's controversial statement on the death of former ATF chief Hemant Karkare. While the committee was to present its report during the last leg of the winter session, Parliament could not transact any business during the concluding days of the session due to the simmering political war of words between the ruling and opposition parties on Antulay's remark.

The committee's findings will be a key factor in shaping further implementation of revised Schedule M in the pharma sector in the country. The industry, particularly the small and medium units, has been eagerly waiting for the Najma committee's findings as the findings will have a far-reaching impact on it. 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 Dr Najma Heptulla-led 12-member committee 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. After hearing all the stakeholders, the committee has taken the views of the Union health ministry. After studying the ministry's views on the issue, the committee finalised the report.