Blowing the whistle on fake drugs

By Shabina Akhter

The government has decided to reward those who provide information on manufacturers and dealers of spurious drugs.

Have you encountered a drug that does not work, leading you to believe that it is fake? Or do you know of anyone who is engaged in the manufacture of spurious drugs? The Union health minister, Ghulam Nabi Azad, recently announced a “whistle blower policy”, aimed at encouraging the common man to provide information about the manufacture of fake drugs. The health ministry plans to give cash rewards to both the informer and the officer who seizes adulterated, spurious or misbranded drugs and cosmetics.

At present, based on the information gathered by the Central Drugs Standard Control Organisation, the office of the Drug Controller General of India raids places suspected of manufacturing or selling such drugs. The tip-off often comes from a member of the general public. The government hopes that a cash reward will lead to more people coming forward with such information.

The Indian Drug Manufacturers Association (IDMA) in Mumbai, which represents the interests of Indian (as opposed to foreign) drug manufacturers, is all praise for the whistle blower policy. “This policy is a timely one. The fact that it seeks to reward people for giving information on the manufacture and sale of spurious drugs is why the chances of it being successful are so high. If implemented properly, this policy will make it difficult for spurious drug makers to operate,” says Daara B. Patel, secretary-general of the IDMA.

According to the Drugs and Cosmetics Act, any drug that has been manufactured by compromising on its quality, or has been stored in such a way that it has lost its properties or has been tampered with or misbranded, is termed spurious. And according to the ministry of health, about five per cent of the drugs sold in the country is counterfeit and 0.3 per cent is spurious. Of course, it is not easy to tell a fake drug from a genuine one. “It’s very difficult to identify a spurious drug,” says T.R. Gopalakrishnan, advisor to the IDMA. “Only a series of chemical analysis can reveal a drug’s spurious nature. However, a case of misbranding can be easily identified,” he says.

One reason for the proliferation of spurious drugs in our country is that there are not enough drug inspectors who can keep a check on quality. “The acute shortage of drug inspectors makes it easier for dealers and manufacturers of spurious drugs to operate with impunity,” says Harinder Sikka, director of corporate affairs, Piramal Healthcare, the pharmaceutical company. “There’s just about one inspector for every 500 chemists in cities like Delhi. What’s more, only seven of the two dozen testing labs across India are functional. The rest of them, according to the Mashelkar Committee (which was set up to look into the drug patent laws in the country) report, are either shut or non operational,” he adds.

Besides, we do not even have an effective adverse drug reaction report system to monitor where and when patients are experiencing an adverse reaction to drugs. In some countries, it is mandatory for hospitals to report to a nodal agency if a patient has adverse reactions after taking a prescribed medicine. But that is not the case in India.

In such a scenario, offering rewards for tip-offs on spurious drugs may go some way in bringing the guilty to book. But experts point out that merely announcing a policy will not be enough. Says Sikka, “One of the major drawbacks of this policy is that people might try to make money out of it by making fictitious claims. Besides, the ministry is yet to decide on vital issues like how to implement the policy, who needs to be alerted and how it would go about protecting the identity of the whistle blower. It is only when the government takes strong measures to implement the policy that the consumer will benefit.”

People do have the option of going to the consumer courts in case they feel that they’ve been duped by fake drugs. “We do get a few consumer cases related to spurious drugs. At the moment we are fighting a case for a client who had bought an ayurvedic product that caused an allergy. Chemical analysis revealed that it had a high content of lead and mercury. The case will now be forwarded to the local food and drugs administration,” says Dr M.S. Kamath, medico-legal consultant and honorary secretary of Mumbai’s Consumer Guidance Society of India.

Since most of us will not be able to distinguish between real and fake drugs, experts advise that some basic rules be followed while buying drugs.

“Make sure that the seal, prints and hologram are genuine. If the prints are a bit blurred or fuzzy, refuse the medicine. But in case you want to lodge a complaint, buy a strip or a bottle of medicine and submit it to the office of the Drug Controller General of India or its zonal offices,” says Dr Kamath.

Under the Drugs and Cosmetics Act, the punishment for selling spurious drugs could be life imprisonment as well as a fine of Rs 10 lakh or three times the value of the confiscated goods, whichever is more.

If you are in doubt about the quality of the medicine you have purchased, “it’s best to go back to the doctor and show the medicines,” advises Dr Kamath.

However, sometimes doctors too are at a loss to know if a particular drug is fake or genuine. As Dr Chandra Kumar Behany, consultant gastro enterologist, Kothari Medical Centre, Calcutta, points out, “Many a time even doctors fail to distinguish between the two. At times both the packaging and printing of spurious drugs are impeccable.”

On the whole, the best bet for consumers would be to buy medicines from reputed shops and insist on a receipt, says Mumbai-based consumer activist Jehangir Gia.

And if you do catch on that you’ve been sold spurious drugs, you can always blow the whistle on the dealer and bring the culprit to book.