BackLax Indian laws mean there’s no cure for ‘wonder drugs’
Lax Indian laws mean there’s no cure for ‘wonder drugs’
PremiumMulti-level marketing: The 4Life product has been in India for nine months ((Ashesh Shah / Mint)
Mumbai: From his house in Santacruz, a western suburb of Mumbai, E.M. Lobo doles out an unclassified substance that he says will cure people of the most lethal ailments—cancer, HIV/AIDS, heart disease, diabetes, blood pressure, arthritis and more. The wonder drug, made by a US-based company, is sold through a network of independent distributors than over pharmacy counters.
Lobo is one of those distributors. He works for 4Life Research USA Llc., a multi-level marketing company which claims that the substance, based on what it calls the “transfer factor" formula, can boost human immunity levels 437% and cure these diseases and disorders. Never mind that the world’s top drug companies are still spending billions of dollars to find cures for most of the conditions this drug addresses.
Transfer factor refers to a group of proteins credited with transferring immunity from parents to their children. It is found in eggs, white blood cells and colostrum, which is a complex milk protein produced in late pregnancy or soon after giving birth.
“We are not doctors but we have common sense, and we know that the only way to build good health is supplements," says Lobo, who calls himself a wellness guru. The company’s drug, he says, is a patented concentrate of transfer factors from cow colostrums and egg yolk. It costs Rs3,000 for a bottle of 60 capsules and has been sold in India for the past nine months.
Earlier, Conybio Healthcare (India) Pvt. Ltd, Japan Life and Amway Corp. took the same path to sell health care products with unsubstantiated claims.
Vasant Pandit , the promoter of Japan Life, was arrested by the Delhi Police in 2005 on charges of duping his distributors and investors of crores of rupees.
The company, which was raided in offices across India, used to sell imported health magnetic beds called the “Japan Life Total Sleeping System" through multi-level marketing claiming cures for arthritis and diabetes.
“As India still does not have laws to regulate food/dietary supplements, many companies take advantage of this and come out with products that they claim are therapies for complicated diseases," says Bhadra Sen Gupta, a leading oncologist in Mumbai who recently initiated a patient awareness programme to guard against quacks and advertisements touting magic remedies.
Lobo claims the transfer factor is not a drug but a nutritional supplement and does not need a prescription. “Transfer factor is not a medicine, drug, vitamin, herb or mineral. It is an immuno-molecule that has all the intelligence like a memory chip. It can transfer the immunity to the body and overnight you enjoy a very powerful immune support."
He says he has even engaged doctors to sell the product. “There is no such thing as prescription. If a doctor understands the product, he will give it to his patients along with other medicines. We are selling transfer factor through a lot of doctors in Mumbai."
Padmanabhan Kubal, another distributor for 4Life in India and an associate of Lobo, cannot stop praising the drug. “My friend was suffering from arthritis for the past 10 years. He was under treatment but it was of no use. But after taking this product, his reports showed an improvement of more than 40% within 20 days," he says.
The duo has support from doctors such as Swati J. Shah, a homeopath practising in Mumbai. Shah says the transfer factor has no side effects. “This is not a medicine and it does not have any side effects. It is not habit-forming and has no threats from overdosing," she says.
India’s Drugs and Magic Remedies Act, a law that is rarely enforced, gives drug regulatory departments or the police the right to take action against misleading advertisements related to treatments, including arrests and seizure of the products.
Maharashtra’s food and drug commissioner S.A. Momin says: “We have booked at least 20 such cases in the last two years in Mumbai, and many companies and individuals are already on trial or have been punished with jail terms and fines."
A couple of years ago, the Kerala government banned the products of Chennai-based Conybio Healthcare, which sold undergarments, stockings, bangles and mattresses that it claimed would cure diabetes, arthritis and heart ailments. However, with no effective regulation to check face-to-face promotions and oral claims, the company could override the ban through multi-level marketing.
Industry estimates show that multi-level marketing, especially those related to the health care segment, has annual sales of at least Rs10,000 crore in India.
In multi-level marketing, an independent distributor recruits people not only to buy and sell products but also to recruit more people. The new hires, in turn, recruit more people, thus forming a chain. Each member earns a commission for expanding the network as well as selling the product.
This kind of marketing was banned in India in 1978. The country’s laws also ban “money circulation schemes" in all forms—multi-level, network and direct marketing—but companies have managed to exploit the loopholes in the system to spread their businesses.
Conybio’s general manager Vijay Chandran says: “Conybio offers fabrics and other bodywear that has bio-ceramics, which emit infra-red rays that help in faster recovery from diseases."
According to him, these products do not require any health-related regulatory clearances in India and are imported from Malaysia. The company did not respond to other queries sent on an email on its multi-level distribution structure.
Rajat Banerji, corporate communication head of Amway Corp. in India, says the company has launched 17 products in the nutritional and wellness segment across the country. However, the company’s official website shows only two such products in its list: Nutrilite and Positrim. “Amway is a direct selling company and believes in selling these products directly from the distributors to the consumers. This is precisely the reason why our products are not available on (shop) shelves," he says.
Although products such as the one sold by 4Life have no approval from the US regulator Food and Drug Administration, Lobo sets forward yet another view. “In most cases, these brands are cleared in the country where they are manufactured. In this case, it is an American company so the regulations are stipulated in the US. Our country has no objection if it is cleared in America because they have a certain understanding from their angle," he argues.
But unlike other multi-level marketing schemes, 4Life distributors in India use brochures and pamphlets to advertise. One of these seen by Mint assures: “Positive result on cancer, heart diseases, diabetes, blood pressure, arthritis, asthma, Parkinson’s, sinus, thyroid, allergies. 4Life transfer factor products have been recommended by the Russian federation for use as immune modulators."
When Mint called 4Life’s US corporate headquarters at Sandy, Utah on 21 February, it was directed to email David Brough, the marketing head of 4Life operations in India. An email sent to him the same day was not responded to.
A senior official of the Central Drugs Standards Control Organisation, India’s apex drug regulatory body that clears all new drugs for the local market and oversees import regulations for drugs and therapeutic products, says he had little information on 4Life. Adds Momin: “Multi-level marketing schemes often do not use publicity material as these people canvas their customers on a one-to-one basis. So, it has become a challenge for regulators to get enough proof against the false claims."
Former drug controller general of India M. Venkateswarlu says the law has to be amended to cover all new frauds. If a company labels a product as a food or dietary supplement, there is no legal provision to control its quality, manufacturing and marketing it does not fall under either drug or food categories.
The Union government had in 2000 proposed a dietary supplement Bill, but a draft itself did not find consensus among various ministries and departments and has been in cold storage since. Taking advantage of this, several companies have started labelling their “magic remedy" products as dietary supplements.
khushboo.n@livemint.com
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