schedule-m guidelines

The Ministry of Health and Family Welfare has amended "Schedule M" to the Drugs and Cosmetics Rules, 1945 which relates to Good Manufacturing Practices (GMPs) 

to be followed by the drug manufacturers. The Government had earlier published draft rules and the objections and suggestions received from the public were taken into consideration before finalising the amendment.

"Schedule M" prescribes GMPs and requirements of premises, plant and equipment needed to be evolved by the manufacturers of drugs during the course of manufacture of drugs or before setting up a new manufacturing unit. These guidelines are essential pre requisites for maintenance of Quality Control (QC) in the production of drugs and pharmaceuticals. Each licensee is required to update these practices through appropriate methodology, systems, procedures, documentation, etc., so as to keep pace with the advances in technology.

The present amendment to "Schedule M" is a progressive mechanism to harmonize the production of drugs and pharmaceuticals and to meet the requirements of international guidelines as recommended by WHO.

The revised "Schedule M" incorporates specific requirements for production of different pharmaceutical dosage forms which include I.V. fluids, ophthalmic preparation, solid dosages formulation (tablets and capsules), bulk drugs, etc. The requirements of plant and equipment and the minimum areas of premises for the dosage forms have also been revised. A minimum ancillary area (approximately 10 sq.m.) for basic installation has also been incorporated for each functional component of manufacturing process to accommodate associated activities. The revised "Schedule M" also envisages the requirements for documentation at every stage of production, validation of processes and equipment; efficient Standard Operating Procedures (SOP) during different stages of manufacture and quality control operations; training of technical personnel engaged in the manufacture and testing. The concept of self inspection and preparation of Site Master File containing factual information on GMPs observed in connection with production and QC activities carried out by the licensee.

The amended rules come into force with immediate effect. However, these rules shall not apply to the manufacturers who are presently licensed to manufacture drugs for the period up to December 2003.



THE Government has amended the Good Manufacturing Practices (GMP) outlined in Schedule M to the Drugs and Cosmetics Rules to ensure that manufacturing units comply with the WHO and international standards of production.

Under the amended rules, it has been decided that the ancillary area requirements for plant and equipment for manufacture of majority of formulations have been deleted. Certain changes in the air handling system have also been made apart from certain other minor changes to streamline the requirements.

The State licensing authorities have been given discretionary powers to modify the requirements in respect of certain categories of drugs if they are satisfied that it is necessary to relax or alter the conditions in the particular case which may be recorded in writing. The provisions of the revised Schedule will now be applicable to all the manufacturers from July 1, 2005.

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