Homeopathy is claiming to become mainstream medicine soon. The sector, which has been under strict regulations for the pat 2-3 years, is expected to become far more regulated in the coming years, in India. There will be no more quacks operating in the segment, an industry leader told Pharmabiz.

According to Dr Mukesh Batra, an expert in homeopathic healthcare, standardisation of education is a must in the segment, and presence of sub-standard colleges is one of the major hurdles for the growth of sector. Students passing from these substandard colleges do not have clinical knowledge. Regulation in academics is the need of the hour.

“There are laws in place in homeopathy, but they need to be implemented in true spirit,” said the source.

Indian homeopathy drugs are currently being exported to neighbouring countries such as Pakistan, Sri Lanka and Bangladesh. But to be able to export the drugs to the US or to the western countries, quality of these drugs needed to be enhanced, the source added.

Today France, Switzerland, US and Britain are still rated as the major producers of quality homeopathy drugs superior than drugs produced from other countries. But seeing the low cost associated with manufacturing in countries such as India, MNCs are keen to set up manufacturing base to produce homeopathy medicines in this part of the world.

With the Central Government planning to bring in stringent Good Manufacturing Practice guidelines for homoeopathy drug making units, there can be a tremendous growth in the coming years. An exhaustive revision of the Schedule M I of the Drugs and Cosmetics Rules 1945 to prescribe GMP and requirement of premises, plant and equipment for homoeopathic medicines would soon be in place.

Pharmabiz earlier reported, the significant addition in the draft GMP for homeopathy is the requirement for a quality control division. Every homoeopathic drug-manufacturing unit will have to set up a separate quality control division in its premises. The QC division should be under the control of approved technical staff and is to be responsible for the quality of all raw materials, packing materials and finished goods. The section is to carry out in-process quality checks of the products and shall be responsible for the stability of the products and their prescribed shelf life.

The revised GMP norms call for systematic documentation of procedures. This includes preparation of standard operating procedures, maintenance of records and registers including that of production, raw material procurement, testing, sales, supplies etc.

The Central Government has recently introduced the Indian Medicine and Homeopathy Pharmacy Bill 2005 in Rajya Sabha, to bring in legislation to set up Central Pharmacy Council to regulate education and pharmacy practices in ayurveda, siddha, unani and homeopathy.

The aim of the Central Pharmacy Council for ISM sector is to regulate and standardise education and support services in the ISM sector and to improve the image and standards of ISM products and services in the global arena.