Ministry of Health and Family Welfare on 10th Nov, 2008 issued a notification No. GSR 780 (E) inserting a new Schedule L-I Good Laboratory Practices amending Rule 150 E.

This amendment is made in Part XV (A) for Institutions carrying out test on drugs, cosmetics and Raw Materials on behalf of manufacturers.

This amendment will come in force from 1st day of November, 2010 giving enough time for up gradation of existing Laboratories at Par with amending provisions.

Now as per amending provisions testing institutions are brought at par with Schedule M.

The Laboratories will have to meet the general requirements, premises, Personnel, Equipments, Chemicals and Reagents, Good House keeping an Safety, Maintenance, Calibration and Equipments, Reference Materials, Microbiological Cultures, Quality System, Internal Quality System Audits, Management Review, SOP’s, etc as per amending provisions.

Thus maintenance of Records, Audits etc is brought at par with Schedule M Provisions.

In another amendment GSR 789 (E) dated 15th November, 2008 in Schedule K in item No. 31, under the column class of drugs the sub-item (a), namely “ Arnica Montana Hair Oil” is omitted and after item No. 34 a new entry No. 35 Homeopathic hair oils having up to 3X Potency only is inserted. This is effective from 15th Nov, 2008

8th December 2008

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