Central government has notified the draft of rules for Good Manufacturing Practices And Requirement of Premises, Plant And Equipments for Homoeopathic medicines. Rule shall be replacing the Schedule M 1 of the Drugs and Cosmetics Rules 1945. The draft is notified in consultation with the Drugs Technical Advisory Board [DTAB]. It is an exhaustive document touching all aspects of Homoeopathic manufacturing. Draft was notified on 2nd August 2005 and Govt. has invited response in the form of objections or suggestions from any person with in 45 days of its publication.

Draft rules are divided in to eleven parts, these are being reproduced in part for the benefit of concern persons who can read and react so that any discrepancy can be corrected before these rules are taken as being final.

1 GENERAL REQUIREMENTS: This part of the draft deals with –Location and surroundings and building. It contains directions about the premises, what are the requirements of ideal manufacturing premises. Manufacturing area should not be used for any purpose other than manufacturing. Heating, washing, drying, packing and labeling etc. shall be done in dedicated ancillary area as adjacent to the manufacturing sections concerned. This part also has instructions about the type of rooms, water to be used in manufacturing , disposal of waste, medical services, safety measures , and also about container management.
In this part draft is ambiguous about the eye drops packing, where it mentions that ‘Plastic containers may not be used for eye- drops’. This is an open statement and will require the clear cut emphasis whether the plastic containers can be used for eye- drops or not. Draft here seems to be in favor of certain manufacturers who are packing eye drops in the glass bottles and against the imported segment who are packing eye drops in plastic bottles.

2. PLANTS AND EQUIPMENTS: Design of the plant and equipment required are discussed in this part. Standard operating practices [SOPs] for cleaning and sanitation, personal hygiene of the workers, general and specific upkeep of the plant, equipments and premises and every activity associated with manufacture of drugs including procurement, quarantine, testing and warehousing of material shall be written and adopted. Dos and don’ts in the matter of the use of the plant and equipments as may be applicable, shall be written and displayed in all places.

3.REQUIREMENTS OF EQUIPMENTS AND FACILITIES: There is exhaustive account of equipments needed for different types of manufacturing work-for mother tincture, potentisation, containers, trituration, tableting, pills and globules and also about ointments and ophthalmic preparations. Detail description about material and men-power requirement is mentioned in this section.

4. QUALITY CONTROL DIVISION : The section shall be responsible for ensuring the quality of all raw material, packing materials and finished goods. The section should carry out in – process quality checks of the products also. The function of this division is divided in to 8 parts. Primarily this includes checking the identity, quality and purity of raw material, finished products and also of packaging material. Division shall also monitor the storage and handling of raw materials, finished products, containers, closures and packaging materials.

PERSONAL- The technical staff shall have the minimum qualification of degree in Homoeopathy Pharmacy or Science with Chemistry or botany as the principal subject and experience of not less than two years in the test and analysis of medicines including handling of material.

EQUIPMENTS: Manufacturing unit should be provided with the following equipments
Binocular compound microscope, TLC apparatus, UV lamp viewer, Hot air oven, Polarimeter, Ph meter, Muffle furnace, U.V.spectrophotometer etc.

5.RAW MATERIAL: This part deals with raw materials like –Plant origin, Chemical origin, Animal origin, Sarcodes, Nosodes. However some issues like the atmospheric temperature, material should not be more than six months old, and the restrictions on buying back potency, are controversial and need literature and research support. Restriction that manufacturer should be using own back potency is against the growth of homoeopathic trade and smells of lobbying by big fish in homoeopathic manufacturing

6.PROCEDURES : The design and procedures adopted shall ensure reproduction of the product of the same quality every time. Alcohol and other vehicles used shall be of Homoeopathic pharmacopoeia specification. Formulations shall be preferably in liquid forms and potency of the ingredients shall not exceed 3x, should be detectable quantity except in case of highly poisonous material and toxins eg. KCN which should not be below 6x.
This is again a non –conventional recommendation to restrict the use till 3x, it need to be explained before forcing it as law.

7 .LABORATORY CONTROLS: Tests as per the pharmacopoeia requirements shall be carried out on products and materials. The stability of the products shall be established by proper methods. Control samples shall be preserved for not less than three years after the last sales.

8. PACKING AND LABELING: A minimum area of 50 square meter shall be provided for packing and labeling section.

9. EXPIRY DATE: Not exceeding sixty months from the date of manufacture.
This is again something we need to be sure about before imposing , whether homoeopathic medicines really become ineffective after a certain period , one look forward to concrete evidence to that effect or this is just a procedural binding.

11.RECORDS AND REGISTERS: In conclusion draft rule desire that all records shall be maintained for a period up to one year after the expiry of a batch or for five years whichever is more.

        Vital informer spoke to Dr.P.N, Verma, ex-director HPL on the draft rules for GMP in Homoeopathic manufacturing. He welcomed the step and wanted that govt. should notifiy it at the earliest. Dr.Verma informed that GMP in Allopathy and Ayurveda were notified long time back and such step was long due in homoeopathy. He further said that legal, proper recording keeping is very important for the authentic drug manufacturing in Homoeopathy. He did not agree that GMP rules favour the resourceful manufacturers and in fact told that GMP is not going to increase the cost of medicines, these are the minimum requirements, any good thinking manufacturer would like to obey. On the issue of restriction on back potency he said that all manufacturers can raise their own back potency and moreover Back Potencies available in the open market are not reliable.