The Kerala drug control administration has decided not to issue any new manufacturing licenses for units that have not conformed to the current Good Manufacturing Practices (cGMP) from next year.
With this decision, Kerala will become the first state in the country to insist on a cGMP certification for pharmaceutical units.
The state would allow the existing units, that are in the process of modernisation, to comply with the Schedule M norms as per the deadline of 31st December, 2004. But in the case of new units, the cGMP complainant manufacturing facility would be required for obtaining manufacturing licenses.
Instead of going in for an ordinary Schedule M requirement oriented GMP certification, the state drug control department has already initiated measures to create awareness among the manufacturers to attempt for implementing cGMP complainant facilities, top level sources with the Kerala drug control department told Pharmabiz.
The sources said the state has not granted any new manufacturing license in the recent past, except for a few loan licenses. As per the information available, no new units are coming up in the state at present, which in effect makes the cGMP certification mandate an already implemented rule, instead of waiting up to 1st of January 2005 for official implementation, noted sources.
With this in mind, the Kerala Drugs control department, in association with the Kerala Pharmaceutical Manufacturers Association (KPMA) had organised a two-day workshop, 'KPMA-GMP Meet 2004 - cGMP" for implementation of new Schedule M' in Kochi on 29th and 30th of May 2004 to create awareness among the manufacturers about the need for cGMP certification and the challenges in future.
According to M.P.George, Co-ordinator of the programme, the interactive seminar would mainly discuss about the cGMP requirements and the global challenges in store, than suggesting short cuts and ways to somehow manage a GMP complainant facility as per the Schedule M mandate. The topics for discussion at the workshop would be validation and calibration, WHO-GMP certification, GLP aspects as per Schedule M, stability studies in pharmaceuticals, ICH guidelines, air handling systems, standard operating procedures, documentation, training modules, design and lay out of a model plant etc. Experts from various parts of the country would handle the topics and the interactive sessions.
It may be noted that only five to six units out of a total of 90 odd allopathic drug manufacturers in Kerala have Schedule M compliant manufacturing facilites. Out of this, only two to three units, apart from a few units into blood bag manufacturing and allied raw material production, can boast of facilities having world-class infrastructure and manufacturing processes. More than 95 percent of the units in Kerala are mainly general hospital item manufacturers dependent on Government supplies.