The much-delayed Najma Heptulla committee report, on the impact of the implementation of revised Schedule M on small scale units in the country, will be tabled in the forthcoming session of Parliament. The Union health ministry has already given its comments on the report. The details of the ministry's comments are not available.

According to sources, after studying the recommendations of the Najma Heptulla committee, the ministry has made its comments and the report will be tabled in Parliament in the forthcoming session that begins on October 17. Earlier in August this year, the Najma Heptulla committee had submitted its recommendations to the ministry.

The 12-member parliamentary committee headed by Dr Heptulla was constituted to study the impact of the implementation of revised Schedule M in the pharmaceutical industry in the country, especially the small scale sector. Since its constitution more than two years ago, the committee had undertaken field visits to different parts of the country and had held several rounds of meetings with the industry representatives to get first hand information on the impact of the revised Schedule M on SSIs.

Though the report was expected to be submitted during the monsoon session of Parliament last year, it was delayed after the committee failed to reach some conclusions following the strong reservation by the industry associations. The committee's findings will be a key factor in shaping further implementation of revised Schedule M in the country. Ever since the central government's decision to implement GMP by amending the Schedule M of the Drugs & Cosmetics Act in 2005, there has been an outcry from thousands of small scale pharma units in the country against some of the clauses of the revised Schedule M, especially the establishment of AHU which is too expensive to the small units.

The Najma Heptulla 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 a big relief to the SSIs as these were some of the major hurdles coming in the way of Schedule M implementation by the SSIs.

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 since then as they were incapable of modernizing their manufacturing facilities due to high cost involved in the exercise.