Rajesh Arora on his deathbed

In July 2001 drug inspectors along with members of the Delhi Medical Association (DMA) collected 53 samples from different locations in and around Bhagirath Place. It is a wholesale market notorious for its second hand drugs and scrap market in Delhi. Most of these samples belonged to well-known companies such as Pfizer, Novartis, Lupin, Dabur, and Glaxo. At least nine samples had no medical ingredient and four had it in negligible amounts.³ Whereas in 1997 only 198 pharmaceutical distributors were based around Bhagirath Place, by 2001, the number had shot up to 693.⁴

Cough expectorant manufactured by a company in Gurgaon was found to be contaminated with diethylene glycol; 36 children from 2 months to 6 years of age who were admitted to two hospitals in Delhi between 1 April and 9 June 1998 developed high fever and kidney failure and 33 children died in three days.⁵ A number of such stories appear in the lost corners in the city newspapers that receive nothing more than a glance.

Bihar and Uttar Pradesh are the two states where the problem of counterfeit medicines prevails in the form of a huge money-making industry. Recently in October 2002 in Patna, the alleged spurious drug racket kingpin Kumar Sahu was arrested. Yet the State Drug Control Office has not cancelled the licence of Sahu's medicine shop "Subh Laxmi Agency." The Bihar Drug Control Administration has no infrastructure to test the samples that they collected from Sahu's shop nor is there any facility available at the central government laboratoryat Ghaziabad.⁶ The trade thus, continues right under the very nose of the drug control authorities. In a small residential area just outside Hyderabad, there are more than 200 pharmaceutical companies. Some of these are publicly traded at the Indian Stock Exchange. The operations of these 'companies' can range from a garden shed to a warehouse. "In the next 10 years, spurious drugs will be the single biggest problem" in public health, says Ranjit Roychoudhury, president of the Delhi Society for the Promotion of the Use of Rational Drugs.

But why do counterfeit medicines persist? Is there an inherent under-supply of medicines, or is there too much demand? Are patients and buyers too ignorant to check for differences between fake and real thing? Or is the government and its agencies too weak to control the entry of counterfeit drugs? The truth lies in them all, but the government and its agencies — the Drug Controller Authority (DCA) under the Ministry of Health and Family Welfare — have certainly a more significant role to play.

Global menace
India is not the only country suffering from epidemic of counterfeit medicines. Globally, the trade of counterfeit drugs is conservatively valued at 20 billion dollars and is one of the fastest growing grey economies — after prostitution, narcotics, terrorism and arms trade.⁷ Nearly 10 per cent of the global pharmaceutical commerce is attributed to fake drugs. The most recent examples of fakedrugs include addition of wheat flour in the manufacturing of contraceptive pills and the adding of industrial solvent during the making of paracetamol syrup. Neomycin eye drops and meningococcal vaccine has been found to contain tap water.⁸ Counterfeit drugs lead to tragedies. In 1995, in the Philippines, a multinational drug company discovered counterfeit asthma inhalers. In Nigeria, fake drugs killed 2500 people in 1995 when they were infected with meningitis. Dora Akunyili, director general of The National Agency for Food and Drug Administration (NAFDAC), the agency that safeguards food and drugs standards in Nigeria says, "The evil of fake drug is worse than malaria, HIV/AIDS and armed robbery put together. Whereas AIDS can be avoided, malaria can be prevented and armed robbers can kill a few at a time, fake drugs kill in thousands."⁹

Many people died in Cambodia in May 2000 from counterfeit drugs meant to treat malaria. The consumption of fake paracetamol that was prepared with glycerol contaminated with diethylene glycol — a toxic chemical used as anti-freeze — resulted in the death of 89 people in Haiti in 1995. Fake artesunate, widely present in South East Asia, is increasing the incidence of malaria in the region. A report published in The Lancet showed that fake artesunate in South East Asia ranged from 11 per cent in Thailand to 64 per cent in Vietnam.¹⁰ In May 2001, Colombia's National Institute for the Supervision of Medications & Foods (Invima) discovered a thriving drug operation in Bosa, a poor neighbourhood of Bogotá and found that sale of fake drugs was as lucrative as the cocaine business of Latin America.¹¹

In Russia, counterfeit drugs have increased ten times since 1998 and cover approximately seven per cent of the total market. Most of these drugs include antibiotics, insulin, and drugs for heart diseases. More than 60 per cent of the drugs sold are fake versions of Russian brands. An estimated loss of over $100 million occurs annually due to fake drugs.¹² The same is true for drugs for tuberculosis in east Europe, AIDS in Africa and Thailand, infectious diseases in South America and in the poorest regions of Africa.

The concerns in the USA and the richer European countries are more in the area of counterfeit lifestyle drugs. Following transcript from a hearing in Washington shows their efforts against it:

"On May 17th, 2002 seven individuals and five companies were indicted by a New York grand jury and charged with manufacturing counterfeit Viagra and selling it over the Internet. The investigation covered a 17-month period during which investigators purchased 28,000 bogus Viagra tablets from China and India. Wholesalers in Hong Kong and resellers in Florida, Nevada, and Colorado operate hand-in-glove. The wholesalers were also linked with a counterfeit product that was found in three cities in China. Another aspect of this case involved Girith Vishwanath of Benzo Chemical industry in India who sold a tablet-punching machine that weighed 1,500 pounds to undercover operators and offered a constant supply of tablets blend for his customers to manufacture his own Viagra. Those indicted bragged that they could deliver 2.5 million counterfeit Viagra tablets to New York each month. Ingenious criminals were able to import counterfeit medicine notwithstanding the current regulations and border controls. Any lessening of those regulations and controls will expose American consumers to an unacceptable level of risk."¹³

India is at the forefront of exporting spurious drugs too. In September 2000, the Delhi Police arrested four Uzbek women and an Indian for possessing 800 kilogrammes of spurious drugs valued at Rs 2 million. Supply of the spurious drugs was traced to UNISUL Private Limited, located at Sonepat in Uttar Pradesh (UP). On reaching Delhi, these medicines were stored in different godowns in Delhi at Nangli Devat village and Aaram Bagh. The four Uzbek women had come to India to sell Chinese silk and later on tied up with the local suppliers for dealing in spurious drugs.¹⁴

In Vietnam and Myanmar, according to WHO more than 40 per cent of antibiotics that are imported from India and as much as 11 per cent of antibiotics in the market are fake or substandard.¹⁵ In Africa, especially Nigeria, Kenya, Tanzania and their neighbouring countries are severely affected by the invasion of counterfeit drugs from India and the Indian subcontinent. Raid at an illegal warehouse in Nigeria, revealed alleged revalidating of fake Actifed and Menstrogen tablets with forged labels and packets containing the names of Indian firms as manufacturers of the sub-standard drugs.¹⁶ In July 2000, Italian authorities seized two tons of raw materials for counterfeit drugs transported from India and China for packaging in Europe and sale in North and South America. In addition, about 5 to-8 per cent of bulk drugs shipped in the US either are counterfeit, unapproved, or substandard.

Flavine International, a USA based pharmaceutical firm admitted in 1996 that it had imported nine counterfeit drugs since years. One of them included gentamicin, a common antibiotic. The Food and Drugs Administration (FDA), Maryland, USA, believes that counterfeit gentamicin may have been responsible for as many as 66 deaths in the US and hundreds of severe reactions. The FDA also has admitted to having little or no information concerning about 4,600 foreign drug manufacturers that have shipped products to the US since October 1997, including 409 in India. The 1996 internal memo of the FDA states that it literally has no control over the fake drugs that enter the US. It warns, "These drugs can reach anyone including the President."¹⁷