The Najma Heptulla parliamentary committee, constituted to study the impact of the implementation of revised Schedule M amongst small scale units in the country, is learnt to have recommended a host of flexibilities including relaxation on space stipulation and air handling units (AHU). The committee has recently submitted its recommendations to the union health ministry. The report will be tabled in the forthcoming monsoon session of Parliament which is expected to be convened in the last week of August.

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. Thousands of SSIs had to shut down their units ever since the Central government's decision to implement GMP by amending the Schedule M of the Drugs & Cosmetics Act in 2005 as they were incapable of modernizing their manufacturing facilities due to high cost involved in the exercise.

SSIs were of the view that while WHO GMP is silent on space stipulations, Schedule M has specified spaces for each section namely injectables, tablets, syrups and capsules, etc irrespective of the fact whether it is SSI or large industry. Many SSIs do not even have spare space available to extend and comply with Schedule M. They also argued that installation of AHUs is not only expensive but unviable too owing to space. As per Schedule M norms AHUs should be vertically placed, which is not possible as service floors cannot be constructed in existing units. While there is justification in AHUs for sterile injectables, where no terminal sterilization is possible, there is no justification in AHUs elsewhere.

Since its constitution more than two years ago, the 12-member parliamentary panel headed by Rajya Sabha MP Dr Najma Heptulla 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 report was expected to be submitted during the monsoon session of Parliament last year, it was inordinately delayed after the committee failed to reach some conclusions following the 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.