The menace of spurious drugs is not a problem of the poor and developing countries alone. It is a major challenge in the US, world's largest pharmaceutical market and also of many developed nations of Europe and Asia. In India, the menace, earlier confined to mostly northern states, has spread to all over the country during the last five years. Apart from affecting the poor patients, growth in spurious drugs manufacture and sales has started hitting the sales and profitability of pharma companies quite significantly in recent years. Established branded products of top Indian and international companies are the targets of spurious manufacturers today.
Brands in antibiotics, analgesics and anti-diarhoeial are the preferred target segments by the fake manufacturers. In fact, the seriousness of this problem was understood by authorities and non-government organizations only after pharma companies started raising the issue in various public forums. As the manufacture of spurious drugs is totally an illegal activity, no convincing estimate of production and availability of these products are available with governments or any other agencies. In fact, no serious attempts have been made by the governments of these countries including India so far to undertake a realistic assessment of this illegal market.
However there is an awakening now amongst some of the governments to this issue. In India, the government has taken an important step, a few months ago, with the appointment of a high-power committee headed by the eminent scientist, Dr R N Mashelkar, to study the issue and recommend measures to curb this menace. He has almost completed his job with a great amount of commitment and honesty and the report will be with the government shortly.
The main facilitator of the sale of spurious drugs anywhere in the world is the pharmaceutical trade. Without the support of the people running the retail pharmacies, no spurious drug can reach the ultimate consumer, the patient. Everyone knows this. The owners of retail chemists have the attraction of a huge trade margin when they knowingly take stock of a fake product of an established brand. If the problem can be tackled at this point, the menace ends then and there. It is at this point, everyone has failed.
Whenever the issue of spurious drugs is raised in any public forum, the trade bodies wash their hands off by saying that their members are not engaged in this activity at all. To what extent this claim of the trade bodies is correct is something to be examined. It is possible that most of the members of the trade and the trade bodies may not be selling fake products. But, there are a good number of unscrupulous elements in this community who are selling these products. Now, the issue is how the trade bodies or the members of the trade can be convinced or forced to help to track down these bad elements of their community. The answer to this question is not very easy to find.
Some of the pharmaceutical companies which were hit by the fake traders in the past have attempted to track down spurious manufacturing facilities by taking the help of private detectives and the local police. Such actions, although had some degree of success, were quite hard and expensive and could not be sustained because of the underworld support to this illegal activity. Indian Pharmaceutical Alliance, an industry association of research based Indian pharma companies, has also been active in tracking down spurious manufacturers which are hurting IPA members in northern states for some time. These sporadic and localized actions of individual companies or of one association cannot bring any worthwhile relief to this problem.
The regulatory authorities in states have all the right to inspect the premises of a pharmacy, seize stocks of spurious drugs, cancel the license and start the prosecution against the offenders. But for that state drug authorities have to be extremely vigilant and their intelligence and inspections have to be regular. The manufacturers of spurious drugs could be easily located by questioning the unscrupulous members of the trading community. But this is not happening in most of the states. There are many reasons for this. Large states like UP, Bihar, Madhya Pradesh, Orissa and most of the eastern states do not have an effective state drug administration. One cannot, therefore, expect, any regular inspection or monitoring of pharmacies in these states. Even in developed states like Maharashtra, Gujarat, Karnataka, Andhra Pradesh and Kerala, functioning of the drug administration is not very satisfactory because of funds shortage, inadequacy of staff and a general lack of will to contain this problem.
Drug inspectors in these states do conduct occasional inspections of the premises of retail chemists, wholesalers and manufacturers and seize stocks and file cases. What is discouraging the honest officials here is the long delays in disposing of the cases. Mashelkar Committee's suggestion, in this context, to constitute special courts throughout the country to try spurious drug cases and to establish a network of informers makes a lot of sense.
The existing judicial system has not been effective in handling cases of spurious drug manufacturing and distribution as the judges, mostly of lower courts, are taking longer time to decide on account of accumulation of cases. These proposed special courts with special judicial powers should take up only cases relating to spurious drugs. That will enable the judges to have a speedy adjudication of such cases. Similarly, a network of informers with attractive incentives should be an effective way to help the police to nab the spurious manufacturers and dealers.