COUNTERFEIT DRUGS IN INDIA

Transcription

1 COUNTERFEIT DRUGS IN INDIA a part presentation from the on-going dissertation Global Threat of Counterfeit Drugs A Study Covering Extent of Problem and Anticounterfeit Measures in Europe & India By, Viraj Mehta Ph.D. supervisor Prof. Dr. H.G. Schweim University of Bonn, April 2008 Viraj Mehta/ April 2008 Counterfeit Drugs in India 1

2 WHO Definition A counterfeit pharmaceuticals product is a product that is deliberately and fraudulently mislabeled with respect to identity and/ or source. Counterfeit products may include products with correct ingredients, wrong ingredients, without active ingredients, with the incorrect quantity of active ingredient or with fake packaging Viraj Mehta/ April 2008 Counterfeit Drugs in India 2

3 Counterfeit drugs A global problem It is a vast, global and underreported problem WHO estimates 10% of total drugs on the world market, worth billion US$, to be counterfeit Fake drugs are responsible for killing numerous lives around the globe e.g. 1,92,000 patients have died in China just during 2001 Interpol categorized it as a form of organized crime and means to finance their activities by some terrorist groups Viraj Mehta/ April 2008 Counterfeit Drugs in India 3

4 Extent of counterfeit drugs in India Source Estimation Estimation based on Media up to 35% Various sources Indian State s drugs administration authorities Associated Chambers of Commerce & Industry of India 0.24 to 0.47% 10.64% (sub-standard) 20% 38% (of Govt. supplies) Samples tested during Various surveys WHO Govt. of India Nigerian National Agency for Food & Drugs Administration Pharmaceutical Research & Manufacturers of America Special 301 Submission % in developing countries, however no official estimation for India due to lack of studies No official estimations due to lack of studies Identified India as one of the sources of fake drugs supply to the country Identified India as significant source of counterfeit drugs through online pharmacies Viraj Mehta/ April 2008 Counterfeit Drugs in India 4

5 Indian drugs regulatory system The Central Drug Standard Control Organization (CDSCO) is a decentralized body with distinct functions of the Central and State agencies and the drugs manufacturing licenses are responsibility of States Definition of spurious drugs introduced in the Drugs & Cosmetics Act during 1982 There exists a gray-zone between spurious (intentional act) and sub-standard drugs (non-intentional act) Viraj Mehta/ April 2008 Counterfeit Drugs in India 5

6 Reasons for counterfeit drugs in India Poverty Inadequate health system Inadequate regulatory infrastructure Lack of enforcement of existing laws Weak penal actions Lack of coordination between various agencies Agglomerated and uncontrolled retail outlets Insecure distribution network Corruption and conflict of interest Internet sale of drugs Viraj Mehta/ April 2008 Counterfeit Drugs in India 6

7 Measures to combat counterfeit drugs in India I The essence of drugs anti-counterfeiting strategy for India lies in: Determining real extent of the problem Strengthening regulatory infrastructure and effective collaboration between various agencies Making judicial proceedings effective by speedy trials and imposing tougher penalties Securing medicinal products totally - from raw material procuring until effective post-marketing vigilance system Dealing with corruption Improving healthcare system Increased international collaboration Viraj Mehta/ April 2008 Counterfeit Drugs in India 7

8 Measures to combat counterfeit drugs in India II Based on the Mashelkar committee report A comprehensive examination of drug regulatory issues, including the problem of spurious drugs, major amendments to central drugs Legislation The Drugs & Cosmetics Act is under consideration Proposed major changes are: - creation of Central Drugs Authority (CDA) as an autonomous body, which will issue manufacturing licenses centrally - strengthening of regulatory infrastructure and testing facilities - provision of stringent penalties for drugs related crime Viraj Mehta/ April 2008 Counterfeit Drugs in India 8

9 Thank You Viraj Mehta/ April 2008 Counterfeit Drugs in India 9