DINAKARAN NEWS

Tighter regulations likely for vitamin supplement market

New Delhi: The government is planning to tighten the regulatory landscape of the R4,500-crore vitamins and neutraceuticals market in the country. Different arms of government — the drug regulator, Drug Controller General of India (DCGI), and the food regulator, Food Safety and Standards Authority of India (FSSAI) — are taking a series of steps to correct the anomaly of multivitamins getting marketed as dietary supplements. First, DCGI may make it mandatory for all such vitamin manufacturers who use any drug as ingredients in their products to take a no-objection certificate from the government. This is likely to become compulsory for manufacturers who use medicinal ingredients for 'non medicinal use', which would include food supplements.
This permission may become mandatory in two cases — when drug substances are being imported for non-medicinal use and when drug substances are getting manufactured for non-medicinal uses, clearly targeting vitamins and nutraceuticals which are being marketed as food supplements. Additionally, the drug regulator has decided to form a committee with officials of DCGI, FSSAI and state drug regulators as its members to lay down guidelines for food and pharma companies in the vitamin and neutraceuticals business.
A decision to this effect was taken in a recent meeting of Drug Technical Advisory Board (DTAB). "It was also agreed that the manufacturers intending to manufacture such formulations should be asked to provide the method of analysis or testing protocols for testing of the finished formulations to ensure that these formulations conform to the prescribed standards," an official said.
In the last few months, the food regulator has been issuing multiple directions to state food regulator offices to not issue licences for food supplements, which, under law, can only be issued by the central regulator — FSSAI. State food regulators were even instructed to cancel and withdraw licences erroneously granted.
The blurred line between drug and food supplement surfaced in 2009 when the drug price regulator — National Pharma Pricing Authority — said that pharma firms are marketing drugs as food supplement to escape the price ceiling net.
In a letter to the health ministry, it cited the example of food supplements such as Ranbaxy's Revital and Germany-based Merck KgaA's vitamin E product Evion, which, it said, were earlier getting marketed as drugs. A Bihar High Court order of 2009, however, held that health supplements marketed by various drug companies such as Feradol manufactured by Pfizer, Revital (Ranbaxy), A to Z (Alkem), Beneficial, CSN and DSN capsules (Shreya Life Sciences) need to be marketed as health supplements as the manufacturers have made no therapeutic claims on the label to suggest that can cure.
The Indian nutraceutical market — R4,400 crore in 2009 — is expected to more than double to R9,500 crore by 2013. Currently, multivitamins marketed as food supplement are just required to label their product 'not for medicinal use'.

Bogged down by cases, govt stops raids on eateries

HENNAI: The Chennai Corporation may be seizing tonnes of rotting meat from railway stations, but the food safety department has not cracked down on eateries and shops that sell substandard food since June this year.

Food safety department officials said they were unable to take legal action against shops after the Madras high court in June stayed central regulations requiring small eateries and restaurants to conform to quality norms such as registration, employing a technical person, chemical analysis of food sample and ban on menu adaptation. However, the court has not stayed inspections by food safety department.

Corporation officials said raids on eateries were now the duty of the food safety department. A senior official in the food safety department said there were 31 writ petitions filed against the department by shop owners. This has dampened the department's efforts.

Records of the food safety department say that between August last year and June this year, only 457 samples of food products were tested. They found 41 samples to be adulterated or misbranded. The most adulterated food products were milk (25 samples), tea & coffee (seven) and drinking water (four). Officials said there were six laboratories across the state to check the quality of food products, but nothing much is done of late.

Meanwhile, shop owners said the Food Safety and Standards Act, 2006 is too stringent. Under the act, a fine up to Rs 10 lakh can be imposed for a small violation, they said. R Srinivasan, secretary of Tamil Nadu Hotels Association, said: "It's difficult to meet the standards prescribed in the act, because most raw materials used to make food are contaminated."

The food safety department is also responsible for issuing licences to shops. The 2006 act makes it compulsory for eateries and hotels with a turnover of less than Rs 12 lakh to register with the department. The act stipulates that food traders with an annual turnover of up to Rs 12 lakh should pay a registration fee of Rs 100. Those with a turnover of more than Rs 12 lakh have to remit Rs 5,000. But only a few traders in the state have registered or got licence from the department. Data show that 13,153 licenses and
91,693 registrations were issued by the department. The number of licences include those for hotels (1,539), restaurants (1,048) and retail trade (3,440). Registrations have been given for 4,973 hotels, 995 restaurants and 42,594 retail traders.

Consumer activists said that the act should be implemented effectively. "It is the duty of the food safety officials to provide hygienic food to the public. There should be proper enforcement without corruption," said Consumers Association of India trustee R Desikan.

Govt to ban sale of gutka, other chewable tobacco

CHENNAI: The state government is likely to ban gutka and pan masala containing tobacco and nicotine in a couple of weeks. The food safety department has recommended a ban on the manufacture, sale and storage of such products under the Food Safety and Standards Authority of India (FSSAI) regulation issued on August 1, 2011.

Madhya Pradesh, Kerala, Bihar, Rajasthan, Maharashtra, Haryana, Chhattisgarh, Jharkhand and Delhi have already banned these products. A senior official said: "Under the act, the food safety commissioner has the power to ban gutka and paan masala. We are sure we will be able to enforce the ban as early as possible," he said.

According to the Food Safety and Standards (Prohibition and Restrictions on Sales) Regulations of 2011, the food safety commissioner has the powers to prohibit -- in the interest of public health -- the manufacture, storage, distribution and sale of any article of food either in the whole of the state or a part for a period not exceeding one year. The act includes Rule 2.3.4, according to which tobacco and nicotine should not be used as ingredients in any food products. The state could now ban gutka using this regulation coupled with a Supreme Court ruling that stated, "since pan masala, gutka and supari are eaten for taste and nourishment, they are all food." The central government has also sent letters to all states proposing a ban on these tobacco products.

A public interest litigation petition filed by advocate P T Geotom is pending with the Madras High Court which ordered notice to the chief secretary, health secretary, commissioner of food safety and others. Geotom said he had sent a representation to the authorities on August 4, 2012 requesting a ban on sale of consumable tobacco products and restrictions on sale of cigarettes near educational institutions and no-smoking zones

The state has registered a rise in the incidence of oral and other forms of cancer, since a sizeable population is addicted to such products. Health activists and NGOs had been pushing for a ban on tobacco products. Anti-tobacco activists cite several reasons for banning gutka. A recent report of the Union ministry of health states that 28 out of the 3,095 chemical components in chewing tobacco products (including gutka) are proven carcinogens. The most abundant group of carcinogens is the tobacco-specific N-nitrosamines. More than 90% of oral cancer in India is directly associated with tobacco use. India spends 300 billion annually in both public and private on treatment of tobacco-related illnesses.

Food Safety Act: Traders get only 'assurance,' no action

Indore: The grievances of trader community regarding Food Safety and Standards Act are still far from being addressed as the Centre has not taken any concrete step in that direction so far.
The traders have been opposing some of the provisions of this act calling them too 'harsh'.
Several representations were made by the traders before various concerned bodies, including Food Safety and Standard Authority of India early this year to bring about alterations in the act.
However traders claim that 'stringent' provisions of the act were yet to be altered by the centre.
"Recently, a letter was received from union health minister Ghulam Nabi Azad, in which the minister only assured to look into the controversial provisions of the act ," said Ramesh Khandelwal, president of MP Food Manufacturers and Sellers Federation, which is leading traders against the act in the state.
Khandelwal, however, added that traders would continue to apply for food licences under the act, as they have reservations against few of its norms and not the entire act.
Food safety officer Manish Swami told DNA that till date around 5,000 applications have been received for registrations and licences under the act in this financial year.
He added that the food department has made registrations and issued licences to around 1,500 traders in the city.
Swami also clarified that deadline for renewal of licences has been extended by six months on August 5.