Faking it - II: Countering and preventing counterfeiting of drugs

Abstract

Byline: G. Swaminath A Stitch in Time Despite being one of the most important tools of the physician in ameliorating illness, the singular lack of attention and importance given to the selection and purity of pharmaceutical brands prescribed is shocking. It is often said that the workman is as good as his skill and his tools. Physicians all over the globe spend immense time and effort in upgrading their skills in diagnosis and therapeutic techniques. However, the unshakable faith in the quality of drugs prescribed often results in the change of diagnosis or the therapeutic molecule in case of non-response rather than of the brand, which might be the real culprit. The problem of counterfeit medicines, rare in the developed countries, is an everyday reality in India and other developing countries.[sup] [1] According to a report, Nimulid (Nimesulide) manufactured by Panacea Biotech had more than 35 counterfeits in the market at one time. Counterfeiters not only copy the trademark, the label design and the trade dress of a well-known branded product, they also copy addresses and pose as licensees.[sup] [2] Counterfeit drugs are a major cause of morbidity, mortality, and loss of public confidence in medicines and health structures. Despite close cooperation between drug companies, governments, or international organizations concerned with trade, health, customs and excise, and counterfeiting, the prevalence of counterfeit drugs appears to be rising.[sup] [3] The remedy to this global problem lies in appropriate regulatory processes and rules and strict implementation of these, along with coordination between the players at every level from the policy maker to the regulator to the consumer. The World Health Organisation (WHO) has now taken the lead in the global effort to combat counterfeit medicines.[sup] [1] It has created the first global partnership known as the International Medicinal Products Anti-Counterfeiting Taskforce (IMPACT). IMPACT comprises all 193 WHO Member States on a voluntary basis and includes international organizations, enforcement agencies, national drug regulatory authorities, customs and police organizations, non-governmental organizations, associations representing pharmaceutical manufacturers and wholesalers, health professionals and patients' groups. These groups have joined to improve coordination and harmonization among countries so that eventually the production, trading and selling of fake medicines will cease. To accomplish this mandate, IMPACT will focus on the following five key areas: i) Legislative and regulatory infrastructure, ii) Regulatory implementation, iii) Enforcement, iv) Technology, and v) Risk communication.[sup][1] It is expected to monitor systems, processes and implementation of regulatory and enforcement areas in each country and will advise on measures to effectively implement them.[sup] [1] The government and the regulatory authorities have a major role in servicing and coordination in all five areas, while doctors and pharmaceutical companies have a role in both technology and risk communication (which has been elaborated in this column). To curb the incidence of counterfeit drugs, the governments need to strengthen their drug regulatory authorities and their powers to enforce drug laws and regulations. The governments should re-work the existing law and ensure that selling spurious drugs is no longer considered a minor offence, now punishable by the state drug controller by suspension or cancellation of license.[sup] [4] The Mashelkar committee (1993)[sup] [5] recommends strict vigilance, with regular surprise checks at pharmacies and for the cause checks (suspicious checks). The report recognizes the lack of infrastructure and personnel to carry out these checks and recommends drastic upgradation and overhaul of the vigilance structure.[sup] [5] Incidentally, there are no accessible testing services for fake drugs anywhere. …