Pharmacovigilance and Its Use in ASU & H

Pharmacovigilance is the science dedicated to reduce the risk of drug-related harms to patients. In India, National Pharmacovigilance Program under the control of Central Drug Standards Control Organization (CDSCO) has initiated during 2003. WHO emphasizes that, traditional medicines are to be included into pharmacovigilance system and has published guidelines on safety monitoring of herbal medicines in pharmacovigilance systems in 2004.

The nationwide programme under central sector scheme funded by Ministry of AYUSH, New Delhi for ASU & H drugs to establish and manage a data base of Adverse Drug Reactions (ADR) for developing system wise database of adverse drug reactions and evolving evidence based recommendations towards clinical safety of ASU & H Drugs. Besides this; the program also undertake surveillance of objectionable or misleading advertisements.

Since ages Ayurveda, Siddha and Unani systems are being practised in India. In this era of globalization, concerns are being raised with regards to their clinical safety. Ayurveda has categorized toxic plants separately and for their use special processing is essential. There is a wide spread misconception that all drugs of “natural” origin are “safe”. There is also a common belief that long term use of a medicine based on tradition, assures both safety and efficacy. Further when ASU & H medicines are used in conjunction with other medicines, there is a possibility of drug interactions. There are also examples of ASU & H medicines being adulterated or contaminated with allopathic medicines, chemicals such as corticosteroids, non-sterodial anti-inflammatory agents etc. Further many ASU & H drugs are manufactured for global use and they have moved beyond the traditional and cultural framework for which they were originally intended. Currently, majority of adverse events related to the use of herbal / traditional products that are reported are attributed either due to poor product quality or to improper use.

ASU & H systems of medicines have their own principles and have their own pharmacopoeia, but at times even are practised in the country as OTC drugs without any authentic prescription.

Considering the growing use of ASU & H products and medicines globally; inclusion of traditional medicines in Pharmacovigilance systems became equally important. Pharmacovigilance is defined as the detection, assessment and prevention of adverse drug reactions in humans.

Ministry of AYUSH, Government of India, New Delhi has initiated the Pharmacovigilance Program for ASU & H drugs. Worldwide movement for the improvement of patient safety gains momentum, the subject of drug safety becomes even more prominent. Pharmacovigilance is the science dedicated to reduce the risk of drug-related harms to the consumers. Looking into the conditions prevailing in the present scenario, it is high time to deliberate regarding the concerns over traditional and classical Ayurvedic, Siddha, Unani and Homoeopathy products and practices. Thus the program is initiated to collect, collate and analyze data to establish evidence for clinical safety of ASU & H drugs in a scientific manner for documenting clinical evidence of safety and to undertake surveillance of misleading advertisements of ASU & H drugs and improper advertisements of ASU & H drugs for regulatory actions.

The program shall be coordinated by NPvCC under the supervision of Ministry of AYUSH, New Delhi that would monitor the program and also recommend regulatory interventions based on the generated Adverse Drug Reaction (ADR) data and objectionable advertisements.