The Pharmaceutical industry in India is valued at Rs. 90,000 Crore and is growing at the rate of 12 – 14 % per annum. Exports are growing at 25 % Compound Annual Growth Rate (CAGR) every year. The total export of Pharma products is to the extent of Rs. 40,000 Crore. India is now being recognized as the ‘Global pharmacy of Generic Drugs’ & has distinction of providing generic quality drugs at affordable cost. India is also emerging rapidly as a hub of Global Clinical trials & a destination for Drug Discovery & Development.
Further, more & more new drugs are being introduced into the country which include New Chemical Entities (NCE), high techpharma products, vaccines as well as new dosage forms, new routes of drug administrations and new therapeutic claims of existing drugs. This is reflected in the fact that total number of applications received & processed have more than doubled from around 10,000 in the Year 2005 to 22,806 in Year 2009 at CDSCO, HQ, New Delhi. This includes increase in New Drug Applications, Global Clinical Trials, Market Authorization of Vaccine & Biotech products from 1200 ,100 ,10 in Year 2005 to 1753, 262 & 137 in the Year 2009 respectively.
Such rapid induction of NCEs and High tech Pharma products in the market throw up the challenges of monitoring Adverse Drug Reactions (ADRs) over large population base.All medicines (pharmaceuticals and vaccines) have side effects. Some of these side effects are known, while many are still unknown even though that medicine has been in clinical use for several years. It is important to monitor both the known and hitherto unknown side effects of medicines in order to determine any new information available in relation to their safety profile. In a vast country like India with a population of over 1.2 Billion with vast ethnic variability, different disease prevalence patterns, practice of different systems of medicines, different socioeconomic status, it is important to have a standardized and robust pharmacovigilance and drug safety monitoringprogramme for the nation. Collecting this information in a systematic manner and analyzing the data to reach a meaningful conclusion on the continued use of these medicines is the rationale to institute this program for India.
Since, there are considerable social and economic consequences of ADRs there is a need to engage health-care professionals, in a well structured programme to build synergies for monitoring ADRs. The purpose of the Pharmacovigilance Program of India is to collect, collate and analyze data to arrive at an inference to recommend regulatory interventions, besides communicating risks to healthcare professionals and the public
The Central Drugs Standard Control Organization (CDSCO), Directorate General of Health Services under the aegis of Ministry of Health & Family Welfare, Government of India in collaboration with Indian Pharmacopeia commission, Ghaziabad is initiating a nation-wide Pharmacovigilance programme for protecting the health of the patients by assuring drug safety. The programmeshall be coordinated by the Indian Pharmacopeia commission, Ghaziabad as a National Coordinating Centre (NCC). The centre will operate under the supervision of a Steering Committee.
Love this post! This is a really good blog wish more people would read this, you offer some really good suggestions on Pharmacovigilance Training. Thanks for sharing!
ReplyDelete