The Union Health Ministry is planning to introduce good manufacturing practice (GMP) norms for non-sterilized and non-medicated surgical dressings soon. The norms would chart out specific requirements of premises, equipment and raw materials for manufacture of surgical dressings, an activity hitherto carried out at cottage industry level in the country.
The ministry intends to insert a separate section as part 1 G in Schedule M relating to this sector, it is learnt.
As per the new requirements, the units manufacturing surgical dressings will have to be set up with separate areas for bleaching-washing-drying, rolling and cutting, labeling and packing etc. The rule would also insist upon tamper proof primary packing.
Maintenance of records for purchase of raw materials, in-process control, batch manufacturing records, testing, sale and distribution, complaint and recall and also records of reference samples would have to be maintained.
The government move is in the wake of the insistence of the purchasing organizations for WHO GMP Certificate for bandages and absorbent cotton.
The Central Drugs Standard Control Organisation (CDSCO) had asked an expert group consisting of Drugs Controllers of Delhi, UP, Rajasthan, Director CIPL and JDCI, CDSCO North Zone to examine the issue in its totality and suggest the manufacturing norms, which may be relevant to this sector of industry. The group recommended that there should be minimum benchmarks of GMP requirements in Schedule M to monitor control on raw materials etc.
Since these items are also being purchased and used by Govt institutions, the group had proposed that requirements should be laid down of the purpose to have sanitation, hygienic conditions, storage, QC, documentation, distribution records etc.
The CDSCO has felt the need for a new part Schedule M relating to specific requirements of premises, equipment and materials for manufacture or non-sterilized and non-medicated surgical dressings, it is learnt.
The Schedule M of Drugs and Cosmetics Rules 1945 currently spells out specific requirements for the manufacture of sterile products, parenteral preparations and sterile ophthalmic preparations (Part 1 A), oral solid dosage forms (Part 1 B), oral liquids (Part 1 C), external preparations (Part I D), metered dose inhalers (Part 1 E) and Bulk drugs (Part 1 F).