Rohit Sharma

Last month, the Delhi Police busted an inter-state racket of fake drugs. They arrested Vikas Sharma, the owner of a drug manufacturing unit in East Delhi from where a large quantity of spurious drugs, packaging materials and packing machines were seized. Sharma sold ayurvedic tablets in the market under the name of various branded companies. And just a few days ago, 14 FIRs were registered against people found guilty of selling counterfeit medicines in different parts of Bihar after raids were conducted in the state.

What is surprising is that all of this came close on the heels of the Ministry of Health and Family Welfare nationwide survey saying that the extent of fake drugs sold in India has been hugely overestimated. The survey conducted by the Central Drugs Standard Control Organization (CDSCO) showed that the prevalence of spurious drugs is at 0.046% of all medicines sold to customers - a point that stayed indigestible for the pharmaceutical companies.

True or False?

There have been various reports on the percentage of fake drugs sold in the country, but with huge variations in the findings. The figures quoted in the media and by different sources have varied from 0.5% and 35%. However, in a sheer contrast to the CDSCO report, the average figure of fake medicines across various independent studies is 15-20%, with an annual rate of growth at 25% and manufacturing concentrated in the northern states.

The European Commission’s Taxation and Customs Union’s report on Community Customs Activities on Counterfeit and Piracy stated that 34.6% of the articles (counterfeit medicine) seized were from India. In 2008, Assocham said the fake drugs market is growing at an alarming rate of 20-25%, which has exceeded the Rs 150-billion per-annum mark. It pointed out that the sale of spurious drug in the National Capital Region (NCR) is almost Rs 3 billion per annum. The whopper came from the Organization for Economic Cooperation and Development’s (OECD) report in 2008 that said 75% of fake drugs supplied the world over have their origins in India. According to a report by The Financial Express in 2009, only fake allopathic and homeopathic medicines contribute 15-20% of Indian pharmaceutical market pie. So who’s telling the truth?

Ignorance is Deadly

The problem of fake drugs in India is growing at such a fast speed that it has almost become a parallel industry in itself. The pharmaceutical industry in the country is at US$ 10 billion currently and is projected to touch US$ 20 billion in the next five years, according to KPMG. If 10% of the drugs produced are substandard, one can imagine its deadly spread in the next few years.

According to the Indian Drug Review’s (IDR) Drug Compendium 2008, there are 20,000 registered brands, but the number of unregistered brands could be double this figure. There are around 20,000 manufacturers, with many of them being small manufacturers licensed to make generic drugs. We can assume there could be an equal number of unlicensed manufacturers producing generics.

There are several reasons for the spread of counterfeit drugs in India - poverty, inadequate health system and 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. The recent and bubbling propagator is the sales of fake drugs through the internet. Those seeking cheaper, quicker and unauthorized treatment form the major buyers. According to WHO, there are numerous illegal internet pharmacies selling medications without prescriptions and using unapproved or counterfeit products. In some cases, internet pharmacies operate internationally and sell products that have an unknown origin. It says that in over 50% of cases (globally), medicines purchased over the internet from illegal sites that conceal their physical address have been found to be counterfeit.

Spurious drugs are a cause for concern for all those who are working in health sector, such as doctors, pharmacists, nurses, health regulators and pharma giants. Fake drugs were initially found to be among lifestyle drugs like Viagra or common medicines for cold and fever. But things are different today. The fake drug malady has stretched to cover lifesaving drugs treating AIDS, diabetes, cholesterol, and even cancer. The worst affected are, unfortunately, the consumers who trap themselves in the web of fake drugs with no help.

Booster Shot Needed

In 2003, the Indian government approved the law of death penalty for people who manufacture and sell counterfeit drugs. Recently, Union Health Minister Ghulam Nabi Azad launched plans to root out the fake drug industry. He said the government would bring the Drugs and Cosmetics Amendment Bill for creating a Central Drug Authority which will make the regulatory mechanism robust. A whistle blower scheme was also announced under which anyone providing information about the manufacture of spurious drugs would be rewarded up to Rs 25 lakhs. All the measures are in great attempts on the government’s behalf to defend the image of its burgeoning pharmaceutical industry.

With starking dissimilarity in many studies pointing fingers towards India, the government’s report seem to be a classic tactic used to get positive media coverage. Recent accusations from Nigeria led to the discovery of China’s emergence as the real culprit in the fake drug market – this was after Uganda and Libya had already banned drug supply from India. Incidentally, it came at a time when India was being bracketed by the US Trade Representative (USTR) and put on “priority watch list” for unauthorised use of bulk active pharmaceutical ingredients (APIs) to manufacture counterfeit products. Not surprisingly, the government has since woken up from the deep slumber and sprung to shield the pharma façade.

While the government’s plan with strictest of punishments would make counterfeiters like Vikas Sharma think twice, the issue of fake drug peddling might remain untouched as reports like the CDSCO’s give hints to complacency and ignorance. The Indian regulatory system has the responsibility to protect people from the threats of spurious and substandard drugs, and prepare Indian companies to meet the highest standards of the global market. The last users of the drugs - doctors and patients - should be educated and made aware of the problem, and also take responsibility in curbing the menace. It is high time the government made up for the decades of unawareness and silence.

Indiabiznews