With a view to enhance the manufacturing standards on par with global practices, the central government had recently amended schedule M guidelines of the Drugs and Cosmetics Act.

The revised guidelines for the state will be enacted from 31 December 2003, it is learnt. Currently, the state FDA is drafting a detailed checklist for plan approval, documentation and plant infrastructure as per the new norms prescribed in the Drugs Act.

Inspections to assess the impact of new guidelines in the manufacturing sector will follow. This is crucial to finalise implementation guidelines, the sources add.

To facilitate the whole exercise, the administration will classify the manufacturing units into two groups: those which require only to upgrade the documentation process and those units which require additional investment to meet up with GMP standards.

The sources say strict implementation of the guidelines is likely to draw dissent from many manufacturers. For example, the new GMP rules call for manufacturers to allocate more space to the active area.

Earlier the area specified for tablet manufacturing was 30 sq mt, which now has been increased to 40 sq mt. Similarly, the area for capsules and liquid orals has been increased to 30 sq mt from 20 sq mt, respectively.

Changes are also mandated for small volume injectibles and large volume parenterals. The area for preparation and filtration has been substantially increased and airlocks and air-handling units have been made compulsory.

Additional areas would mean fresh investments in land and redesigning of units. In case no land is available for expansion, the units will be asked to close down one of the lines (either tablets, capsules or liquid orals) to meet the requirements. Also, units operating in non-industrial areas will be asked to relocate to industrial areas.

The FDA has issued 4,000 licenses in the state. But the number of units (including small sector industries [SSI] units) will be only a couple of hundreds, as the majority of licenses are issued for third-party manufacturing, as per the sources.

The SSI sector is expected to be the worst hit by the new rules, it is argued. It is because a majority of large and medium scale facilities have upgraded the units or are in the process of doing so.