The final notification on revised GMP guidelines for homeopathy will be issued within a couple of months, by providing two years time for the drug manufacturers to comply the guidelines, according to official sources.

Currently, the government is carrying out minor corrections as 'final touches' on the draft notification issued in the second half of year 2005, according to Dr S P Singh, advisor (Homeopathy), Department of AYUSH.

He said that though the GMP guidelines have some changes from Schedule M I of the Drugs and Cosmetics Rules 1945 prescribing GMP and requirement of premises, plant and equipment for homoeopathic medicines, the industry would not find it difficult to comply, as the modifications results minimum expenditure.

"We have taken care of the industry with our sympathy for the manufacturers. The compliance will not be a problem if the industry cooperates with the authority," Singh said.

He added that enough time will be allowed for the homeopathic drug manufacturers, and the government will extend help to the small-scale manufacturers. There are 642 licensed homoeopathic drug manufacturers and around 2 lakh homeopathic practitioners in India.

The ministry has also plans to encourage setting up of more R&D centres and drug testing laboratories for homoeopathy. The industry is supposed to facilitate an R&D wing in the premises of the factory itself. But the government is not considering it as mandatory, and will be satisfied if the R&D, drug testing lab is available in the neighbouring homeopathic firm, he added.

More drug testing laboratories will be established in various parts of the country. Within a period of two years, drug-testing laboratories for homeopathic drugs will be available in around 8 states.
"There is no need of establishing quality testing labs in all the states. The states, which are having less players in the industry can utilise the testing laboratory of the nearby state," added Singh.

The revised GMP norms insist on systematic documentation procedures in homoeopathic drug manufacturing units. The norms include preparation of Standard Operating Procedures (SOP), maintenance of records and registers including that of production, raw material procurement, testing, sales and supplies, log book of equipment, master formula records, records of medical examination and fitness of personnel etc.