High time smokeless tobacco was banned

Plethora of legal provisions to support a ban, yet there has been no deicision

sonal

Sonal Matharu | November 14, 2011


#tobacco   #ministry of health and family welfare   #gutkha   #smokeless tobacco  


On August 1, the movement for banning chewing tobacco in India saw a turn in its favour. The Food Safety and Standards Authority (FSSA), a statutory body under the health ministry to handle food related issues, notified new regulations called the Food Safety and Standards (Prohibition and Restrictions on Sales) Regulations, 2011. It states under rule 2.3.4 that “product not to contain any substance which may be injurious to health:
Tobacco and nicotine shall not be used as ingredients in any food products”.

The definition of ‘food’, under the Food Safety and Standards Act, 2006, is a substance whether processed, partially processed or unprocessed, which is intended for human consumption. And ‘ingredient’ means any substance, including a food additive used in the manufacture or preparation of food and present in the final product, possibly in a modified form (see box below).

As per the definitions and the new rules notified, products like gutkha, pan masala and
khaini (and other such items containing nicotine and/or tobacco) fall under the purview of the FSSA. Hence, selling these products became illegal from August 5, 2011, when these regulations came into force.

An official from the FSSAI in New Delhi, who requested not to be named, confirms, “Gutkha and pan masala fall under the regulation of FSSA. This rule will be applicable unless the health ministry amends this and notifies it. So far we have not received any objections or complaints from the manufacturers of such products.”

The health ministry, however, seemed to be oblivious of such a move being planned by a body under it, as the ministry has always maintained that banning the chewing tobacco products is not possible immediately and that it is a process which will take time.

B K Prasad, joint secretary in the ministry who is in charge of the tobacco related issues, admits that he was not aware that the FSSAI had taken such a decision. “There were no consultations with the ministry. FSSAI is an independent body. It can make its own rules.
It need not consult us,” he clarifies.

At the same time, Prasad maintains that banning chewing tobacco products is not easy given the number of people employed in the industry. “There are six million people employed in the tobacco industry, we cannot ban the tobacco products. We can only regulate them,” he says.

By not banning gutkha, pan masala, khaini and other chewing tobacco products, the apex body in the country for ensuring public health is putting at stake the lives of 26 crore men, women and children who are currently users of tobacco, argues Dr Pankaj Chaturvedi, surgeon from Tata Memorial Hospital, Mumbai.

“At least 9 crore of these 26 crore will die prematurely,” he says. “And this number will increase in the coming years.”

According to the health ministry’s own figures, 90 percent of all oral cancer cases are due to the consumption of chewing tobacco.

New findings

Out of all the chewing tobacco products used in India, according to the Global Adult
Tobacco Survey (GATS), khaini, a mixture of tobacco and lime, is used the most at 12 percent followed by gutkha, a mixture of tobacco, lime and areca nut, at eight percent.
Betel quid with tobacco has a six percent share and tobacco used in the form of dentrifice is five percent. A total of 21 percent Indians use only smokeless tobacco, the prevalence of which is higher in the rural areas. Gutkha, though, is equally prevalent in both urban and rural areas.

These findings released in January 2011 changed the course of the tobacco control policy in India.

From regulating cigarettes, that is, the smoking tobacco industry, the focus shifted to the smokeless tobacco industry which grew unchecked all this while, killing lakhs by the contents of its two gram pouches.

The hoardings and advertisements released by the ministry now have specific warnings about smokeless tobacco consumption as well. In July, the ministry launched a nation- wide media campaign on tobacco control, which Prasad says, is the biggest such campaign in the world.

The health ministry also organised a national consultation on smokeless tobacco in April
2011 where health secretary K Chandramouli said, “Smokeless tobacco addiction has already assumed the dimension of an epidemic.” More than 80 tobacco control experts attended the consultation along with representatives from the World Health
Organisation (WHO) and FSSAI.

Too little, too late

But the efforts to curb the “epidemic” have been too little, too late.

The pictorial warnings were to be revised in December 2010, but it will now happen in December 2011, late by a year. Even though India has the maximum number of oral cancer cases due to smokeless tobacco consumption, the new warnings are milder than what countries like Australia, Brazil, Belgium, Hong Kong and Chile carry on similar products sold there.

Considering the magnitude of health hazards of smokeless tobacco, it was unanimously decided at the national consultation to “impose a complete ban on smokeless tobacco products”. This claim is validated as it is attached in the affidavit submitted by the health ministry in the supreme court on July 14, 2011 in the Ankur Gutka versus Indian Asthama Care Society case.

Less than a month after submitting the affidavit, the ministry has changed its stand – apparently to save the livelihood of a large number of people.

Dr Chaturvedi is not convinced. He says, “The government is not trying to reduce the number of people dependent on tobacco for livelihood. These six million are not being rehabilitated elsewhere. The industry has always used the farmer as an emotional turning point. But the farmer is the ultimate loser. All the profit made by tobacco goes to the big companies and nothing comes back to the farmer.”

Doctors write to PM

Meanwhile, a civil society movement pressing for a ban on smokeless tobacco products has gained momentum.

In May 2011, the chief ministers of 11 states signed a pledge which was sent to the prime minister urging him to ban smokeless tobacco in India. These states are Punjab, Rajasthan, Gujarat, Uttarakhand, Chhattisgarh, Maharashtra, Goa, Kerala, Karnataka, Arunachal Pradesh and Assam.

The directors of 16 regional cancer centres in India individually wrote letters to the prime minister in April 2011 and highlighted the issue of the rising number of cancers in the head and neck region in the states they serve due to smokeless tobacco consumption. These cancer centres are in Mumbai and Nagpur in Maharashtra, Rajasthan, Gujarat, Haryana, Chhattisgarh, Bihar, Madhya Pradesh, Assam, Tripura, West Bengal, Tamil Nadu, Karnataka, Andhra Pradesh, Orissa and Kerala.

Dr Pankaj M Shah, honorary director of Gujarat Cancer and Research Institute, noted, “Oral cancer has now become more prominent with the extensive use of smokeless tobacco. Earlier more cases were recorded of throat and lung cancer due to smoking, now we see people between 20 to 40 years old suffering from mouth cancer.”

Dr R K Chaudhary, director of Acharya Tulsi Regional Cancer Treatment and Research Institute in Bikaner, wrote in his letter, “Our government is spending huge amount of money on cancer control programme and on the other hand we are not removing the root causes of cancers, that is, tobacco and gutkha which are known causes of cancer development.”

Dr Chaudhary told Governance Now, “Not only men, but school children and housewives are also addicted to chewing tobacco products. Many people keep gutkha it their mouth even while sleeping, so this is worse than smoking a cigarette.”

Dr A C Kataki, director of Dr Bhubaneshwar Borooah Cancer Institute, Guwahati, wrote in his letter that as per a global school personnel survey of 2006, 34.3 percent children between 13 and 15 years consume tobacco in the northeast. “Tobacco products are distributed free in and around educational institutions, hospitals and hospital premises,” he wrote.

“In the city of Guwahati alone, gutkha worth Rs 12 lakh is sold every day. 6.5 lakh sachets of gutkha and 3.2 lakh packets of cigarettes are sold every day in Assam,” Kataki added.

Dr Gautam Majumdar, medical superintendent of the Regional Cancer Centre, Agartala,
wrote that cheap gutkha packets were now easily available in Tripura and tobacco consumption had doubled recently.

Voice of Victims

The Voluntary Health Association of India (VHAI) and various other NGOs supporting the cause of tobacco ban, along with the doctors from Tata Memorial Hospital and survivors of cancers of head and neck region started a series called the ‘Voice of
Victims’ where the victims of cancer due to smokeless tobacco narrated their stories of addiction and the struggle to survive cancer to ministers, bureaucrats and politicians invited at the sessions.

Learn from states

But all this momentum gathering steam has had no effect on the health ministry. In fact, in the area of chewing tobacco control, the centre has a lot to learn from the states. Between 2001 and 2003, five states attempted to ban chewing tobacco and pan masala.
Maharashtra banned chewing tobacco in 2002. Andhra Pradesh, Bihar and Tamil Nadu also attempted it. However, Goa is the only state today that has continued its ban on the sale of chewing tobacco.
 
The recommendations and demand to ban chewing tobacco is not new to the health ministry. Various departments and committees under the ministry have earlier called for a ban on chewing tobacco products in public interest.

In 1994, a Jaipur-based NGO called Indian Asthma Care Society filed a writ petition in the Rajasthan high court for a ban on smokeless tobacco. The court asked the director general of health services (DGHS) to file a report on the effects of gutkha and pan masala.

The health ministry asked the Indian Council of Medical Research (ICMR) to file a report on the harmful effects of smokeless tobacco products.

In September 1997, an expert committee on the use of tobacco in pan masala and
gutkha, under the chairmanship of the DGHS, “strongly recommended the prohibition on use of tobacco as an ingredient in any food item”, says the above mentioned affidavit submitted in the SC recently. The committee further recommended the prohibition on the consumption of pan masala, gutkha and chewing tobacco as they are injurious to public health.

The minutes of the meeting note that the consumption of pan masala containing smokeless tobacco has shown a tremendous increase as it has reported that pan masala industry has grown from an estimated Rs 200 crore in 1992 to well over Rs 1,000 crore in 1997.

The committee took note of the efforts made by Maharashtra and Goa to ban smokeless tobacco and of the studies carried out by National Institute of Nutrition, Hyderabad, Chittaranjan National Cancer Institute, Kolkata, and Tata Institute of Fundamental Research, Mumbai, linking smokeless tobacco to health problems.

It also noted that a declaration was made by the judiciary in the US stating that food and drugs administration can regulate the use of tobacco including cigarette due to its adverse effect on health. And countries like Australia, Hong Kong, Ireland, Israel, Japan and New
Zealand have imposed a ban on import, manufacture and sale of smokeless tobacco.

“Occurrence of oral sub-mucous fibrosis which was earlier restricted to adult population is now commonly seen among teenagers addicted to pan masala containing tobacco/gutkha/ chewing tobacco,” the minutes of the meeting say.

A month later, the Central Committee of Food Standards unanimously favoured a ban on the use of smokeless tobacco in pan masala/gutkha or as an ingredient in food items based on the expert group’s report on the same. It also came to this conclusion after reviewing the study done by ICMR, and noting state government efforts to ban smokeless tobacco.

The committee also took note of the findings of the Supreme Court in Laxmikant versus Union of India case in 1997 where the central government notification dated April 30, 1992, prohibiting the use of tobacco in toothpaste/toothpowders in public interest was challenged. The SC upheld the said notification and observed that the “imposition of total ban is in public interest”.

However, the health ministry did not accept the recommendations of either of the committees. Instead, in order to ‘regulate’ the tobacco industry, the ministry introduced the Cigarette and Other Tobacco Products (Prohibition of Advertisement and Regulation of Trade and Commerce, Production, Supply and Distribution) Act, 2003.

The act banned smoking in public places. It prohibited advertisement of cigarettes and other tobacco products and selling these products within the radius of 100 yards of an educational institution and to a person who is under the age of 18 years. But the act also included tobacco as a constituent of pan masala, thereby, taking all products containing tobacco under its purview. This means, tobacco products were no longer regulated under the Prevention of Food Adulteration Act (PFA), which is a general law but were now regulated under COTPA which is a special law. Thus, this provided legal protection for the smokeless tobacco sold in India.

The main focus of COTPA was on banning surrogate advertisement for cigarettes.
It hardly touched upon smokeless tobacco, though it is listed in the schedule of COTPA. Evidence of this can be seen at public places in Delhi itself. Several companies have launched pan masala with the same brand name as their gutkha product and advertise the former to push the latter. The surrogate ads also state that pan masala contains “zero percent tobacco”.

The limitation under COTPA is that tobacco products listed in the schedule can only be ‘regulated’ and not ‘banned’.

“Though we have a tobacco control law which clearly defines several legal measures to control tobacco use and sale, there is no provision as yet to ban smokeless tobacco products”, said Bhavna Mukhopadhyay, executive director, Voluntary Health Association of India.

In 2003, the WHO came out with an international treaty on public health called the Framework Convention on Tobacco Control (FCTC) to limit the use of tobacco in all forms and for better health of future generations. India became a signatory to it on February 5, 2004. In India, the international treaties and conventions get converted into domestic laws through article 51(c) and 253 of the constitution.

Despite promises made on international platforms, the Indian government has failed to check the growth in sale and prevalence of smokeless tobacco in India, which has grown manifold.

In a report submitted in the supreme court by the health ministry under the Ankur Gutka and Indian Asthma Care Society case, R Croucher and S Islam from Queen Mary’s School of medicine and dentistry, London in their paper titled ‘Socio-economic aspects of areca nut use’ say that innovative methods of packaging were introduced to bring down overall costs in the smokeless tobacco and to create markets. “As with products such as shampoo and toothpaste, the packaging of pan masala has been changed from containers to 10 gram sachets. This change is responsible for an increase in sales in India from five million dollars in 1985 to 66 million dollars in 1991.”

Revolution in Gutkha business

The Smokeless Tobacco Federation’s executive director Sanjay Baichan says, “Growth in the tobacco sector is only in smokeless tobacco. The new generation has taken over the gutkha business. They have introduced new technology and new ways of working. They now have modern machines imported from China, Germany, Sweden, etc. It is an advanced industry.”

A source in the ministry adds to that saying, “In the early 1990s the smokeless tobacco industry saw a revolution. They discovered small pouches. Gutkha and pan masala were packed in small pouches costing just one rupee. This targeted the youth. They could now put the small sachets in their pockets and go around anywhere. Earlier, these products were available in tins and cost more.”

With the production of smokeless tobacco rising, the share of total cultivated tobacco used in smokeless forms of tobacco products has also increased. Between 1976 and 1994, smokeless tobacco production represented between 11 percent and 19 percent of total tobacco production, but production has increased substantially since 1995. (See table 1)

In 2002, 65 million kg of chewing tobacco and 10 million kg of snuff tobacco were produced in India, according to IARC monograph volume 89.

Smokeless tobacco is also gaining popularity in countries where Indians live, notes IARC monograph volume 85. It notes, “These products are exported to all countries where Asian migrants live.” Exports of chewing tobacco or zarda from India have also increased from 424 tonnes in 1995-96 to 3,778 tonnes in 2004-05, according to the tobacco board’s records.

Though the actual worth and size of chewing tobacco industry is unknown, it is estimated to be at Rs 10,000 crore.

Hard nut to crack

Areca nut, one of the main ingredients of smokeless tobacco products and pan masala, is as harmful as tobacco, and so is its regulation. Croucher and Islam of Queen Mary’s School of medicine and dentistry, London, say in a study that the regulation of areca nut products is extremely difficult. “There is a large informal sector, highly decentralized and unlicenced, which operate outside of official control.”

They add that to meet the needs of the mass market, areca nut growing has resulted in replacing other crops like rice besides introducing fertilizer and pesticide application for improve yields.

A trader in smokeless tobacco products from Chandni Chowk in New Delhi compares the commercially available smokeless tobacco with the traditional handmade pan or betel quid. “After the spread and reach of gutkha and pan masala in the country, the sale of pan has gone down by approximately 70 percent of what it was before the 1990s,” he says.

Gutkha became widely popular in the early 1990s. Small pouches were easy to carry and there were over 100 brands of gutkha available, all with different taste and fragrance.

“Machines in chewing tobacco factories have made work faster,” he adds, “The turnover of the industry is unimaginable. In one day, minimum one lakh sacks, each containing 1,800 packets, are sold.”

The regulation by the health ministry has clearly not worked. That is perhaps the reason why India is the second largest consumer of tobacco in the world, second only to China.

Dr Chaturvedi says, “Easy availability of gutkha is a major hurdle. Children who are in their rebellious age see celebrities endorsing products like gutkha and mouth fresheners. They try these products which are highly addictive. A child’s brain is developing and the susceptibility to get addicted to such products is high.”

According to the WHO, the total economic cost of tobacco use in India for 2004 amounted to $1.7 billion, which is many times more than the $551,876 that the Indian government spent on tobacco control activities in 2006. It is 16 percent more than the total excise tax revenues collected from all tobacco products in India in the financial year 2003-04 ($1.46 billion).

Tobacco-attributable direct costs ($1.2 billion) account for 4.7 percent of India’s total national healthcare expenditure in 2004 ($25 billion), according to national health accounts, 2005.

“Despite so much inflation, the price of one product has remained constant or increased only marginally in 25 years, and that is gutkha,” says a source in the health ministry.

One of the ways to check the sale of smokeless tobacco products and reduce prevalence of tobacco consumption in India is to ban small pouches, the source adds. “The increase in tax will be more appreciable in big tin packets. Also, there will be no littering.”

“The ban on plastic sachets for smokeless tobacco should stay. It has affected the industry. The shelf-life of smokeless tobacco has reduced in new packets. Shopkeepers now keep less stocks because chances of it getting spoilt are high with the new paper packaging,” he says.

While the health ministry has been taking baby steps to check the spread of smokeless tobacco addiction, one of its own departments has taken a leap in ensuring better public health. But how soon the rules notified under the FSSA are implemented on ground, only time will tell.

“The industry will definitely appeal in the court against the new FSSA notification and will ask for a particular section of the act to be discussed further. If two laws are conflicting, it is the health of the public which will be supreme,” says Chaturvedi.

BOX: Definitions of food

•    In Godawat Pan Masala Products IP Ltd and another vs Union of India and others, 2004, the supreme court said, “Since pan masala, gutkha and supari are eaten for taste and nourishment, they are all food within the meaning of section 2(v) of the Prevention of Food Adulteration (PFA) Act.” Section 2(ia)(v) of the PFA Act, 1954, defines ‘food’ as: “Any article that is used as food or drink for human consumption and includes any article that ordinarily enters into or is used in the composition or preparation of human food.”

•    Amendments were made to the PFA Act on August 21, 2006. Rule 44J, which was brought into force on August 20, 2007, reads: "Product not to contain any substance which may be injurious to health - tobacco and nicotine shall not be used as ingredients in any food products."

•    Rule 44J was challenged in various high courts by gutkha manufacturers/ distributors and the order was stayed. All the writ petitions pending before various high courts were transferred to the supreme court in 2009. The supreme court in the Godawat Pan Masala case said, “The power of banning an article of food or an article used as ingredient of food, on the ground that it is injurious to health, belongs appropriately to the central government to be exercised in accordance with the rules made under Section 23 of the Act, particularly, sub-section (1A)(f).”

•    With the FSSA notifying the new rules, the PFA, 1954, stands repealed.

BOX: Why can’t the government ban chewing tobacco?

If the government bans chewing tobacco, a legitimate business will be replaced with mafia, says Sanjay Baichan, executive director, Smokeless Tobacco Federation. “In states where there is prohibition, it has totally failed.”

Not denying that chewing tobacco is harmful, he argues that the health ministry can regulate the products if it wants to, the industry will be happy to follow the new regulations. “We want the government to fix the maximum levels of nicotine and tar and we will follow that. The government has so far not done any of that,” he says.

When asked why, in the name of regulation, the government does not ask the industry to give a chart of calorific content on the chewing tobacco packets, B K Prasad, joint secretary, health ministry, states lack of infrastructure as the main reason. “We do not have the facility to test these products,” he admits.

“Unless we have the facility to test the products, we cannot come out with rules to have these companies print ingredients and calorific value on packets. They can write anything they want. We will not be able to test them. We need a mechanism where we can test whether what they are printing is correct,” Prasad says.

Meanwhile, advocates for ban on smokeless tobacco say that the government has no will to ban these products. “Yes, tobacco can’t be banned because there is no political will,” says Dr Chaturvedi.

Prasad refutes, “We cannot ban any product based on some recommendations given at a consultation. There are six million people dependent on tobacco for their livelihood.”

Besides, India does not even have cessation facilities in place, he adds.

According to GATS, the prevalence of tobacco is higher than the national average in 14 states – Arunachal Pradesh, Bihar, Chhattisgarh, Jharkhand, Madhya Pradesh, Manipur,
Meghalaya, Mizoram, Nagaland, Odisha, Sikkim, Tripura, Assam and West Bengal. The prevalence of use of tobacco is the highest in Mizoram at 67 percent.

“Banning a product has never worked in India,” says Baichan.

But GATS proved Baichan wrong. Goa, the only state in the country where smokeless tobacco is banned, has the lowest prevalence of use of tobacco in the country at nine percent.
 

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