A new parliamentary committee is expected to visit the small pharma units in Maharashtra on September 24 to study and understand the issues involved in implementation of revised schedule M in pharmaceutical industry. This is being done as the Dr Najma Heptulla-led parliamentary committee on subordinate legislation could not finalise its report on the subject yet.
Sources said the committee will visit some 10 to 15 SSI units in the state, probably near Mumbai, and will study the implementation of revised Schedule M and its repercussions on the SSI units. The constitution of the committee is yet to be officially announced.
A Parliamentary committee on subordinate legislation under by Rajya Sabha member Dr Najma Heptulla was constituted about a year ago to study the implementation and impact of revised Schedule M in the pharma industry. The committee, which had sittings in different zones of the country for collecting data to finalise the report, was to submit its report in the ongoing monsoon session of Parliament.
The committee's findings will have a major say in shaping further implementation of revised schedule M. But after several meetings with officials and industry representatives, the committee failed to come to any conclusion.
The central government's decision to implement GMP by amending the Schedule M of the Drugs and Cosmetics Act in 2005 invited the wrath of thousands of small scale pharma industries in the country. Industry representatives said some of the clauses of the revised schedule M like the establishment of AHU and space specifications are difficult to implement. The specification on space in the revised schedule M has also come in for severe criticism from the SSI units. "Even in the WHO GMP, there is no space specification. If at all the government wanted to include space specifications, it should be on the new units", an industry association leader said.
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.