Pills That Kill

• Last month, part of a drug consignment meant for Delhi Municipal Corporation-run dispensaries was found to be fake.
  
  
• One crore rupees worth of spurious drugs, seized recently in Patna, included fake labels of reputed firms like Morepen, Ranbaxy and IPCA.
  
  
• In south India, Madurai, Coimbatore and Salem have become major supply centres for illegal medicines.
  
  
• The main dealer of spurious drugs found in Gujarat was traced to border district Sriganganagar in Rajasthan.

"We want penalties to be 'sure, swift and severe'. We have suggested the death penalty for offenders and, to make punishment sure, we have recommended that this be made a non-bailable offence.That way the redressal will be swift," explains Mashelkar (see interview). Adds Vijay Karan, the former head of Delhi Police and IB, who's now involved with a private sector initiative to weed out illegal drugs, "This is probably the worst way to make money. This is worse than murder. This is serial killing."

North India is the major manufacturing hub for pharma fakes. Most of the counterfeiters are based in Delhi, Uttar Pradesh, Haryana and Bihar. States like Madhya Pradesh, Rajasthan, Punjab and Himachal Pradesh are slowly trying to grab a larger slice of this blood-money trade (see chart); profit margins in spurious drugs can be as high as 100 per cent compared to 15-30 per cent for genuine producers. What's alarming is that manufacturing bases are now shifting to other parts of the country—Maharashtra, Gujarat and Andhra Pradesh. "The major (illegal) centres are spread across the northern states," reveals Gujarat's Food and Drugs Control Commissioner S.P. Adeshara. Adds a spokesperson for the Gujarat-based Torrent Pharmaceuticals: "We now have complaints that there is some manufacturing going on even in east and south India."

Nearly two years ago, the Indian Pharmaceutical Alliance (IPA), comprising 13 major pharma producers, set up its own investigative cell, headed by Karan and including several retired intelligence and police personnel, to tackle the problem. In the last 18 months, it has conducted 35 raids and seized fakes worth Rs 15 crore. Of these raids, 21 were in Delhi, the rest in other northern cities.

Some of the illegal manufacturers are among the 20,000 firms registered with either the central or the state drug controllers. During normal work hours, they either make legitimate medicines on sub-contract basis for the big players or their own brands. But, at night, the Jekylls turn into Hydes and switch to fakes. For instance, a Delhi-based manufacturer-exporter was supplying spurious drugs to the city's municipal corporation. Currently, there's a case against him and government sleuths are investigating the charges. Similarly, the Sonepat-based D.K. Laboratories allegedly had a licence to make ayurvedic drugs. But when its factory was raided, investigators found the firm was using chalk powder to make spurious allopathic tablets.

There are hundreds of unlicenced manufacturers who operate out of sheds, one-room outfits and residential areas. In Bulandshahr in western UP, a capping machine was installed in a residential unit to fill injection vials sold under various brand names. Another house in Delhi's Mahavir Enclave was making illegal drugs and supplying them to Patna. A Bulandshahr-based counterfeiter was so enterprising that he would enter his factory surreptitiously at night through the backdoor since his premises had been sealed by authorities for non-payment of dues. He used stolen electricity to make spurious medicines like Voveron, a painkiller.

The worrying aspect is that fakers use the latest printing and packaging technology, making it nearly impossible to figure out the real from the imitation. Even pharma firms are often unable to tell one from the other. P.N. Bhargava, a retired police officer who is part of the IPA's investigative team, recalls how he found Lupin Lab brands during a raid in Delhi's Geeta Colony. Lupin refused to test samples from the cache (worth Rs 2 crore) since they matched their products in every detail. But independent tests blew the charade. Says Prem Chand Ranka, spokesman, Tamil Nadu Pharmaceutical Distributors Association, "They are even able to replicate the batch numbers."

Typically, counterfeiters sell drugs that have a high turnover—those meant to cure common cold, bodyache or fever. Next on their preferred list is expensive, life-saving medicines (anti-cancer or anti-TB), where margins are huge.Explains Harinder S. Sikka, vice-president, Nicholas Piramal: "Anti-TB drugs are a favourite as the government itself buys large quantities to supply to rural areas and dispensaries." As it is easier to bribe government officials, illegal traders find it comfortable dealing with drugs that are purchased in bulk by departments. Now, even lifestyle drugs (health tonics and fairness lotions) and nutritionals (body-building medicines) are being imitated.

There are also misbranded products that are passed off as genuine because of the striking similarities with the originals. In Bihar, it's easy to find brands like Terremycin (real name: Terramycin), Correx (Corex) and Bicosule (Becosule). And there are substandard brands which have the wrong, or no active, ingredients. The main ingredients of spurious drugs are sugar, chalk powder and wheat flour, which have been chosen carefully since they do not have any negative effects and don't show up prominently during clinical tests.

As they don't have the right chemicals and are manufactured in unhygienic conditions, they can have a deadly impact, especially in life-saving situations. But the trick in this trade—like any other illegal one—is to build an efficient distribution network that allows the illegal traders to sell their wares all over the country, and overseas. So, instead of spending money setting up independent systems, the imitators use the legal channels to push their products. They tap dealers in areas like Delhi's Bhagirath Palace or the Dava Mandis in Patna and Lucknow, the wholesale centres for legal medicines.

If companies themselves cannot differentiate fakes, there's no way a chemist or a retailer or a wholesaler can pinpoint them. So, it's easy to slip in the spurious drugs along with the real ones. Delhi's Bhagirath Palace, with over 650 wholesalers and retailers, is one of the largest centres for distribution of drugs, both spurious and legal. But, as Karan puts it: "We found out that 95 per cent of these shops were dealing in spurious drugs and a majority of them either didn't have a licence or sales tax registration numbers." Although this market has been raided several times by drug controllers and Karan's team, it hasn't dented the spirits of the traders.

The problem is that investigators are unable to crack the entire chain—from manufacturers to distributors to retailers. Here's an example of how sophisticated these networks are.Early this year, the police arrested Dalbir Singh and Hira Lal in Delhi with fake Alprax, Ampoxin and Combiflam tablets. Dalbir said the drugs were purchased from two parties in Sonepat and he also linked a transport company to the deal. Further interrogation led the trail to two other people in Delhi who, besides fake medicines, had a tablet-making machine and a packaging unit. These two disclosed the name of a dealer in Patiala, where the police recovered 400 boxes of fake Ampiclox. And then the trail died with the arrest of just five people.

As most of these networks cut across state borders, it becomes difficult for law enforcers to pursue leads or initiate action. "We have traced the source of some spurious drugs available in Tamil Nadu to Haryana and Delhi. Now, being an inter-state issue, they take time to resolve," admits an official from the drug control department in Chennai. Worse, local officials are often hand-in-glove with the traffickers. And it becomes even more difficult to trace the culprits, especially for investigators who come from other states to follow the trail.

On May 30, in Aligarh, a team from Delhi Police faced the ire of a large crowd as it started loading spurious drugs seized from a dealer's shop. The crowd, which converged in the narrow congested lane, snatched the cartons and dragged the accused out of the police's clutches.Later, it was found the crowd had been incited by the local drug inspector who knew the accused, supposedly one of the biggest dealers in fake drugs in the city. And if you think only low-level officials turn a blind eye, look at what happened recently in Bihar, where the annual trade in legal medicines is estimated at Rs 1,500-2,000 crore.

A few months ago, in Patna, the local police led by dsp R.K. Dubey raided nine chemist shops, seven of which didn't have a proper licence. Spurious drugs worth Rs 1 crore were seized and a local drug inspector was suspended because of his complicity in the illegal trade. But this seemingly minor incident led to an open public clash between the state health minister, Shakuni Choudhary, and his junior minister, Akhilesh Singh. The latter went to town claiming that more raids will follow and the "state government will not spare these maut ke saudagar (traders of death)". He also announced that a committee has been set up to probe the nexus between corrupt drug inspectors and the traffickers.

On the floor of the state assembly, Choudhary downplayed the incident. He said fake drugs were available across the country "and Bihar is no exception". He denied that fakes were manufactured in the state. "They are manufactured in Mumbai, Ahmedabad and Noida. It's the responsibility of the Centre to conduct raids on these manufacturing units," he told the assembly. He reinstated the suspended drug inspector and came down sharply on his police officers for arresting him. "The police must call the drugs control wing experts before conducting raids because when even doctors and experts cannot differentiate between genuine and fake drugs, how can the police do it?" he asked.

The stark reality is that the offence is difficult to prove. And it's bailable. Also, if a licensed producer is making a drug that uses harmless ingredients and markets it under his own brand, he can only be booked under minor charges. So, most people who make or sell spurious products get bail easily and minor fines of up to Rs 10,000 are imposed on them.

Some senior government officials, though, feel that the scare is highly exaggerated. "The fear of spurious drugs is more of a perception created through hype by some quarters. The real situation is not that scary," says C.M. Kaneju, Delhi's drug controller. He rattles off figures to prove his contention. According to him, of the 4,993 samples seized in Delhi in the past three years, a mere 61 were found to be spurious, and another 203 were substandard. Of the 1,353 samples seized from traders in Bhagirath Palace during the same period, only eight were found to be spurious and another 36 substandard. Not many in the industry would believe Kaneju, but the fact is no one knows the extent of the problem.

Mashelkar admits that while the industry claims the spurious medicine trade is 20-30 per cent the size of the legal industry, the evidence collected by state authorities indicates the problem is smaller. "We think the truth lies somewhere between these two figures," he says. However, no one denies that the trade is on the rise. Explains Ranjit Sahane, president, Organisation of Pharmaceutical Producers of India and MD of Novartis: "Weak laws, legal loopholes, ill-equipped laboratories and a fragmented national drug regulatory authority have fuelled this activity." Add to that the ease with which one gets a licence to make or sell medicines.

Pharma firms feel India needs an autonomous national drug authority which is either quasi-government or autonomous and has the power to gather intelligence, conduct raids and coordinate between police, legal agencies, state governments and the industry. The Mashelkar committee has suggested centralisation of drug administration, including licensing, to ensure a better central coordination and monitoring not only of licensing but also for manufacture, distribution and sale.

The task force set up by the Confederation of Indian Industries has suggested an incentivised revenue-sharing system for drug inspectors, like it is for customs and excise officers. This will reduce the problem, since industry sources allege the inspectors are part of the racket, may even be owners of outfits dealing with counterfeit drugs. Says Sahane: "Having lost out on checking this menace, we have a catching-up game to play. And all stakeholders have to come together in this." But even changes in existing policies and laws will not be enough. The most important section which has to take up the issue is the consumer. It is his, and her, health in peril.