The Union Ministry of Health and Family Welfare has come out with a Good Laboratory Practices Document for all drugs testing laboratories in the Indian Systems of Medicine (ISM) sector. The guidelines for ISM & Homoeopathic Drugs Testing Laboratories is expected to guide the drug analysts in maintaining high scientific and professional standards and thereby ensuring that only drugs of the highest quality are produced and marketed in the country.
Drug Testing Laboratories of Central Government, State Governments, pharmaceutical manufacturers and various other organisations will have to abide by the guidelines and make sure that sub-standard drugs are not released in the market. According to Malti S. Sinha, secretary, Department of ISM & Homoeopathy, ayurvedic, unani and Homoeopathic Pharmacopoeias published by the Government of India have prescribed various standards to be followed for ISM & Homoeopathic drugs.
"The manufacturing and sale of ISM & Homoeopathic Drugs are increasing day by day as the demand is heavy. Plant materials are being used as home remedies, over-the-counter drug products and raw material by the pharmaceutical industry. It is necessary for the Government to keep a strict vigil on the quality of these drugs and observe Good Laboratory Practices. Keeping this in view, the department has also launched a central scheme for strengthening State Drug Testing laboratories so as to ensure availability of quality ISM & Homoeopathic Drugs," she said.
Accurate analysis for quality control of ISM & Homoeopathic Drugs is the prime requirement for a safe and effective health management programme. The most commonly observed obstacles in getting quality analysis of ISM & Homoeopathic drugs are lack of training of technical personnel, lack of adequate Standard Operating Procedures, lack of adherence to protocols for making accurate observations, lack of equipment/instruments for validation of drugs and improper record keeping.
"Establishment and adherence to appropriate systems is expected to go a long way in ensuring reliability of data pertaining to safety and efficacy of ISM & Homoeopathic Drugs marketed in the country. It is therefore very important that Good Laboratory Practices are followed," she added.