The small pharmaceutical units of Maharashtra have urged the Dr Najma Heptulla-led parliamentary committee to relax clauses like space requirements, air handling units (AHU) and lengthy documentation in the revised schedule M. The SSIs raised their concerns in this regard before the parliamentary committee which made a two-day visit to the state on September 24 and 25.
Sources said the SSIs made a forceful plea before the four-member committee regarding the problems faced by the SSIs in implementing the revised schedule M as the costs for it run into crore of rupees for almost every unit. The SSIs are particularly upset over the mandatory space requirement, AHUs and documentation.
The SSIs lament 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 SSI do not have spare space available to extend and comply Schedule M.
The SSIs apprised the committee that installation of AHUs is not only expensive but also not viable owing to space limitations. It is insisted by FDA many times that 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.
The 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. Other members of the committee who visited Mumbai included Harendra Singh Mallick, P Madhu and Maybel Rebello. Tough the committee had meetings in other parts of the county, it could not finalise the reports so far.
The committee's findings will have a major say in shaping the further implementation of revised schedule M in the country. Even after six years of its notification, SSIs have been unable to implement the schedule M despite several extensions in time granted for its implementation.
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 SSIs in the country against some of the clauses, especially the establishment of AHU which is too expensive for them.
The government's intention of revising the schedule M was to enhance the standard of drug manufacturing to ensure maximum efficacy and safety of medicines. But, 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.