CDSCO to issue notice to remove confusion about Sch L norms

Joseph Alexander, New DelhiWednesday, August 3, 2011, 08:00 Hrs  [IST]

With the confusions and apprehensions still prevailing in the industry, especially among the small scale units over Schedule L and Schedule M norms, the Central Drugs Standard Control Organisation (CDSCO) will be issuing a formal clarification to specify that the Schedule M compliant units need not to bother about Schedule L norms.

The CDSCO is planning to formally clarify the guidelines after the points of confusion were taken up by the industry associations with the Department of Pharmaceuticals which, in turn, had urged the Health Ministry to clarify this. Sources said the Ministry has asked the CDSCO to go into the issue and do the needful, including a formal notice if needed.

Besides, the office of the Drug Controller General of India (DCGI) was also asked to prepare a list to modify the 178 items and equipments currently included in the Credit Linked Capital Subsidy Scheme of the MSME for pharma units to upgrade to GMP norms. The cost details of these equipments and other requirements for Schedule L compliance would also be worked out by the DCGI, sources said. It will clearly specify the items required both for Schedule M and Schedule L.

Sources said as per the existing guidelines, the units which are already GMP-compliant need not again go for GLP norms which are already part of Schedule M guidelines. According to DCGI guidelines, the GLP compliance is applicable only for pre-clinical studies. However, the SSI units have been confused as divergent views were expressed from different quarters, especially after the GLP compliance was made mandatory from last year.

In the case of CLCSS, the DCGI would undertake modification of the list to focus on critical items which make major contributions in production facilities especially and SSI and ME units. Industry associations had been asked to give suggestions for upgrading the current list.