After more than two years of its constitution to delve into the impact of the implementation of revised Schedule M on small scale drug units in the country, the Najma Heptulla committee has completed its recommendations and will soon submit its report to the government. The committee has completed all formalities and the final report will be submitted to the government any time now, it is learnt.
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 has finalized the report some time back.
Though the details of the final recommendations could not be accessed, sources close to the committee said that the Najma Heptulla-led committee 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. Thousands of small drug manufacturers had to close down their units due to financial difficulties ever since the introduction of Schedule M by the government.
The Heptulla committee report was inordinately delayed after the committee failed to reach a consensus following strong reservations 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 industries in the country against some of the clauses of the revised Schedule M, especially the establishment of AHU which is too expensive to afford 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 big relief to the SSIs as these were some of the major hurdles coming in the way of Schedule M implementation by the SSIs.
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 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.
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.