All alternative medicine preparations dispensed and sold in Oman must now be approved by the Ministry of Health (MoH), accordingly to a newly announced regulation.
Practitioners of alternative medicine will come under strict scrutiny as the Ministry of Health (MoH)Ministry of Health (MoH) has made it mandatory to register all alternative medicine preparations to be dispensed and sold in the Sultanate. The Directorate-General of Pharmaceutical Affairs and Drug Control has issued a directive detailing the criteria for registering alternative medicine preparations, including herbal preparations, Ayurvedic preparations, Chinese herbal preparations and homoeopathic preparations.
“Import of any herbal drug must be done through a licensed drug store,” the ministry said, adding that “all private traditional herbal clinics and associated pharmacies and drug stores will have six months time to complete the registration formalities,” according to the directive dated April 7, 2008. Import clearance will not be granted for any consignment after the specified time limit, the circular added.
The move stems from the increase in demand for alternative medicine preparations among Omani residents, the DG of Pharmaceutical Affairs and Drug Control noted in the circular. From time to time, the MoHMoH has been issuing regulations and guidelines to make the availability of these preparations within a legal framework in the Sultanate, it added. These regulations and guidelines focus on ensuring consumer protection by guaranteeing that the preparations imported into the Sultanate are of the highest quality to ensure consumer safety, the directive noted. Alternative medicine is any form of treatment or therapy outside the realm of conventional modern medicine.
Among the popular alternative forms of treatment is Ayurveda, India’s traditional, natural system of medicine that has been practised for more than 5,000 years. Chinese herbal medicine uses combinations of herbs to treat specific diseases. Local agents representing herbal preparations must be licensed and the manufacturer of these preparations must also be registered with the MoH, the circular said. The MoHMoH has the right to request an inspection visit to the manufacturing facility before registration of these products in Oman, it added.
The herbal drug registration requirements include a scientific report from the manufacturer indicating the origin of every ingredient and its pharmacological effect and therapeutic uses; dose, side effects, adverse reactions, precautions, toxicity and antidote; list of countries where the product is marketed or registered, especially in Europe or the USA; drug interactions; date of cultivation and harvesting of herbs; and alcohol content specified in percentage. A letter from the manufacturer must also indicate that the preparation is free from steroids and sex hormones.
The applicant should submit documented information of clinical trials performed in humans or any published scientific papers. Adherence to comprehensive quality control laboratory requirements is also needed for registration of alternative medicine preparations. Priority will be given for registration of products according to their therapeutic importance. Registration of products will be valid for five years.
The herbal drug registration requirements include a scientific report from the manufacturer indicating the origin of every ingredient and its pharmacological effect and therapeutic uses; dose, side effects, adverse reactions, precautions, toxicity and antidote; list of countries where the product is marketed or registered, especially in Europe or the USA; drug interactions; date of cultivation and harvesting of herbs; and alcohol content specified in percentage. A letter from the manufacturer must also indicate that the preparation is free from steroids and sex hormones.
The applicant should submit documented information of clinical trials performed in humans or any published scientific papers. Adherence to comprehensive quality control laboratory requirements is also needed for registration of alternative medicine preparations. Priority will be given for registration of products according to their therapeutic importance. Registration of products will be valid for five years.
By Ebby Chacko George
Source : Oman Daily Observer 2008
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