The Dr Najma Heptulla-led parliamentary committee, constituted to study the implementation of revised Scheduled M and its repercussions on pharmaceutical industry, may not table its report in Parliament in the ongoing monsoon session as the committee could not collect all the necessary data to finalise the report.
Sources said that the committee, which had sittings in different zones of the country, is in the process of collecting data from different zones to finalise the report. "The possibility of tabling the report in the current Parliament session is dim. It will be submitted in the winter session only", an industry observer said.
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. The committee's findings will be a key factor in shaping the 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 government's intention by 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.
Meanwhile, the industry associations representing the SSIs have given a memorandum to the committee to make some changes in the revised Scheduled M so that it could be implemented by the small units. Their major recommendations include removal of clause of AHU except for injectables and micro biology lab to be made optional in revised Schedule M.