Menace of Fake Medicines in India

The article talks about the unprecedented growth of the fake drugs industry in India.

Recently, Ranbaxy’s drugs were found to be of sub-standard quality by the US FDA, thereby banning import of 30 its drugs in the US. What does this signify? A pharmaceutical major of India producing sub standard drugs is not a healthy sign. But the real problem lies that if a leading company like Ranbaxy has done so, how can the quality of drugs from the other small and medium sized pharma companies be assured?

Take this as an alarming sign, because if this is the quality what we export to US and other developed countries, with what is the quality of the drugs with which we cure our people. Certainly the root of the problem lies in our own country and the callous nature of regulatory authorities.

But this has not been the only case, where our drugs have to found of sub- standard quality. Incidences like these have occurred before also. Take the incidence when medicine administered to a 4- year old in Nigeria caused his death. It was 4th such case in Nigeria in 5 weeks. On investigation, it was discovered that the drugs were fake, and most of them imported from India and China.

It is getting so vast that it has become a potential industry in itself. The entire Indian pharmaceutical industry is about $ 10 billion and about 10% of it is producing sub-standard drugs. For, the problem of spurious and sub-standard drugs in the country is quite rampant, as is evident from the periodic reports from the media on seizures and confiscation of fake drugs from go downs or large consignments. These however, constitute only a small fraction of the real and illegal activity, which is not differentiated from the counterfeit trade in other commercial products.

Monitoring of, and control over the pharmaceuticals ought to be more stringent since it concerns health of the citizens and especially in those cases where even minor lapses can lead to losses of life. But, unfortunately we, in India do not have adequate regulations to check such malpractices. No concrete policies have been designed by any Govt so far and such callous attitude and leniency of the part of Govt only helps to spur such illegal activities.

One of the problems in checking the menace of fake drugs is that the inadequacy of data, ie the number of units producing, the total market size, the location of such units, etc.
It is a regularly engrossing industry, with its influence having a wide spectrum of impact. New Delhi is increasingly becoming a hub for fake drugs in India. According to data revealed by the authorities, such units are growing at an unexpected rate in the NCR. The problem is so intense that the out of every 10 drugs sold in the capital, 4 are fake. Empty capsules are sold at a rock bottom price and can be filled with any desired type of drug.

Various factors contributing to the mushrooming growth of spurious drug industry in India are:

    Lack of enforcement of existing laws.
    Weak penal action.
    High remunerative trade
    Ability of improved printing technology that helps counterfeiting
    Lack of control by exporting/ importing countries.
    Too many wholesale and retail outlets.
    Widespread corruption and conflicting of interests.
    Lethargic regulatory authorities.
    Undervaluation of human life.

    Fake drugs, as sold in India can be of different types. Certainly in this context it is about those which are intentionally, manufactured as a malpractice. These can be:
    Capsules filled with substances such as lactose
    Directly compressed starches in the form of tablets packed in company branded packaging strips.
    Expired drugs packaged in attractive containers.
    Injection vials and ampoules filled with original drug look alike aqueous and oily liquids.
    Liquids orals such as syrups without containing any medicament.

    Due to widespread pharmacy retail stores, even the problem of distribution channels is not encountered. So these manufacturers can sell any drug to any store to any customer at the MRP. They also do not have to worry about the marketing costs of these drugs as they are intentionally labeled as the products of reputed companies, even having the same place of manufacturing.

    So, this is not a sign of worry only for the patients and the physicians, but also for the pharma companies whose products are copied. This will inevitably hamper the goodwill of the company.

    A patient paying for medicine will not be able to procure the right medicine, a physician prescribing a medicine will not be able to treat the patients even with the best of his efforts, and patients will unknowingly consume dummy drugs, Multi- national pharma giants in spite of practicing the best of quality control, quality assurance and hygienic measures, following Good Manufacturing Practices, will see their branded drugs in the market having alarmingly low drug contents and poor therapeutic actions.

    This also prevents the foreign pharma firms to enter into India, on the fear that their products would be duplicated, putting their goodwill at stake. This is one of the major challenges facing the pharmaceutical industry today. If any measure is to be taken to curb this malpractice, it has to be taken by the regulatory authorities so as to save our country from this menace.