FDA bans India manufactured Ranbaxy drugs from US market

In a setback to Indian pharmaceutical giant Ranbaxy, the US has prohibited the company from producing and distributing drugs for the American market from its Toansa facility in Punjab.

In an order, the Food and Drug Administration yesterday prohibited Ranbaxy from distributing in the US the drugs manufactured using Active Pharmaceutical Ingredients (API) in Toansa, including drugs made by Ranbaxy's Ohm Laboratories facility in New Jersey. Ranbaxy has also been prohibited from manufacturing API at its Toansa facility for FDA-regulated drug products; exporting API from Toansa to the US for any purpose; and providing API from Toansa to other companies, including other Ranbaxy facilities, making products for American consumers. 

"We are taking swift action to prevent substandard quality products from reaching US consumers," said Carol Bennett, acting director of the Office of Compliance in the FDA's Center for Drug Evaluation and Research. 

"The FDA is committed to ensuring that the drugs American consumers receive, no matter where they are produced, meet quality standards and are safe and effective," he added.

In a statement, FDA said it exercised its authority under a provision in the consent decree which permits the agency to extend the decree's terms to any Ranbaxy-owned or operated facility if an FDA inspection finds the facility in violation of the Federal Food, Drug and Cosmetics Act or FDA regulations, including CGMP requirements. CGMP requirements serve as the primary regulatory safeguard over drug manufacturing and must be followed by companies to ensure manufacturing quality.

The FDA also acted under a separate provision in the decree which permits the agency to order additional corrective actions that FDA determines are necessary to achieve compliance with the law or the decree, it said. 

Follow hygiene rules or face the music: FDA to roadside vendors in Mumbai – Daily News & Analysis

Come February 4, the Food and Drug Administration will crack the whip on all those food business operators, including roadside vendors and hawkers, who have not registered with the regulatory authority under the central government’s Food Safety and Standards Act (FSSA).

The move comes two years after the Food Standards and Safety Authority of India made it mandatory for all food business operators (FBOs) to obtain a licence or register with the state FDA. Under the FSSA, any person or establishment, where food is being handled, processed, manufactured, stored and distributed should conform to basic sanitary and hygienic requirement.

So far, FDA in Maharashtra has registered or licensed 5,73,840 FBOs of which 63,654 operators are in Mumbai alone. There are an estimated 15 lakh FBOs in the state, while Mumbai has over one lakh food business set-ups. These range from top-end restaurants to roadside vendors as also manufacturers of packaged food product or raw material, including dealers of milk, dairy products, meat and oil.

State FDA Commissioner Mahesh Zagade told dna, “February 4 is the last date set by the central government to obtain licences or registration by the FBOs, failing which they will be prosecuted under the law.”

Zagade said that Maharashtra has registered the maximum number of FBOs as compared to any other state in India. “Across India, there are 5.5 crore FBOs of which 18 lakh have registered under FSSA till date. Of these 18 lakh, over five lakh FBOs have registered from Maharashtra alone. With nearly 30 per cent registrations done from Maharashtra alone, we are leading in enforcing the law.”

In the past 20 days, food safety officers have been conducting camps to persuade FBOs to obtain FDA licences or get registered with the regulatory body. “On average, we are conducting forty to fifty camps in a day in the city with an aim to reach out to vendors in concentrated areas of vegetable and fish markets as well as hawkers to make them aware of the importance of maintaining hygiene and sanitation while handling raw or cooked food items,” said Suresh Annapure, joint commissioner (food), FDA.

Caramel colour, used in colas, contains potentially-carcinogenic 4-MeI

Caramel colour (which was among the most used food colours in the world, according to a 2013 report from market research firms Mintel and Leatherhead Food Research) is added to many soft drinks and some foods to turn them brown. However, it does not resemble real caramel. Some types of this artificial colour contain a potentially carcinogenic chemical called 4-methylimidazole (4-MeI).

Under California’s Proposition 65 law, any food or beverage sold in the state that exposes consumers to more than 29 microgram 4-MeI per day is supposed to carry a health-warning label.

In recent tests by Consumer Reports, each of the 12-ounce samples of Pepsi One and Malta Goya had more than 29 micrograms per can or bottle. While this cannot be said to be in violation of California’s Prop 65, these levels are too high, and California’s attorney general has been requested to investigate.

“There’s no reason why consumers should be exposed to the risk that can stem from colouring food brown,” said Urvashi Rangan, toxicologist and executive director, Food Safety and Sustainability Centre, Consumer Reports.

She added, “Lower 4-MeI alternatives are available to manufacturers. Ideally, foods should not contain 4-MeI.”

The risks
In 2007, a federal government study concluded that 4-MeI caused cancer in mice, and the International Agency for Research on Cancer determined the chemical to be “possibly carcinogenic to humans” in 2011.

There’s no federal limit for levels of 4-MeI in foods and beverages, but on January 7, 2012, California stated that manufacturers must label a product sold in the state with a cancer warning if it exposes consumers to more than 29 micrograms of 4-MeI per day. In this case, the exposure comes from consumption.

The California Office of Environmental Health Hazard Assessment used 29 micrograms as the cut-off point because that was the level they determined posed a one in 100,000 risk of cancer (that is, no more than one excess cancer case per 100,000 people who are exposed to that amount daily for a lifetime).

Consumer Reports’ experts think even that risk is too high. “It’s possible to get more than 29 micrograms of 4-MeI in one can of some of the drinks we tested. And even if your choice of soft drink contains half that amount, many people have more than one can per day,” stated Rangan.

“Given that colouring is deliberately added to foods, the amount of 4-MeI in them should pose a negligible risk, which is defined as no more than one excess cancer case in a million people.” To meet that risk level, Consumer Reports’ experts say a soft drink would need to contain about three micrograms or less per can.

Testing

Consumer Reports tested 81 cans and bottles of various popular brands of soft drinks from five manufacturers between April and September 2013. The products were bought from stores in California and the New York metropolitan region.

In December 2013, 29 new samples of the brands that initially tested above 29 micrograms per can or bottle in either location were bought and tested from the same areas.
Findings
While Consumer Reports’ study was not large enough to recommend one brand over another, both rounds of testing found that the level of 4-MeI in the samples of Pepsi One and Malta Goya purchased in both locations exceeded 29 micrograms per can or bottle.

The products purchased in California did not have a cancer-risk warning label.
During the initial testing, the researchers found that some of the other brands bought in California had average levels around or below 29 micrograms per can, but the New York area samples of those same brands tested much higher.

However, in the second test, the levels in the New York samples had dropped. For example, regular Pepsi from the New York area averaged 174 micrograms in the first test and 32 micrograms in the second.

“The fact that we found lower amounts of 4-MeI in our last round of tests suggests that some manufacturers were taking steps to reduce levels, which would be a step in the right direction,” said Rangan.

On average, three brands (Coke, Diet Coke, and Coke Zero) came in under 5 micrograms per can in the tests, a level Consumer Reports’ experts believed was more acceptable. Sprite, a clear soda that was tested as a control, showed no significant levels of 4-MeI.

Collecting food samples on R-Day an exercise in futility Report comes 4-5 days after food had been consumed Tribune News Service

Ludhiana, January 24

The exercise of collecting samples of the eatables to be consumed at the republic day celebrations is an exercise in futility, which has been carried out for years. The report of the samples of food and beverages to be served to the VVIPs and other dignitaries is received four or five days after these had been consumed, though the samples are sent to the laboratory the same day.

With Republic Day just a couple of days away, the Health Department staff are on their toes. The officials, including the District Health Officer and Food Inspectors, are busy collecting the samples of sweets, packaged water and beverages, which will be served during the celebrations. Four or six team comprising Food Inspectors and the District Health Officer have been formed.

“The samples of ‘laddoos’ and packaged water have been collected while the sample of lunch to be served on Republic Day will be collected the same day,” said the District Health Officer, Dr Avinash Kumar.

Certain doctors are of the view it is a sheer waste of time and energy. “The sample of the lunch is collected on the day it is served. The entire process is a waste of manpower and energy as the result of these samples comes four or five days after the food had been consumed,” said a doctor.

Spot testing

Sources in the department said to make sure the food served to the VVIPs during the function was safe, the health officials tasted the food.

A drop of this, pinch of that TO TEST TAINTED FOOD

Adulterated Products Can Cause Stomach, Kidney Ailments

    Aman added a drop of a yellow liquid into a jar of milk. The pure white liquid turned blue. It wasn’t a trick at a magic show but a demonstration at the adulterated food testing counter at the Youth Health Mela at Valluvar Kottam.
    The exhibition, organised by Adyar Cancer Institute, aims to educate people about noncommunicable diseases and ways to prevent them. As part of the event, MBA students of Hindustan University have a stall where they demonstrate simple tests to determine whether a food item is adulterated.
    Food products, ranging from milk and vegetables to ice cream, are adulterated, say health experts. “In order to add colour, texture and bulk to food products, manufacturers mix all kinds of additives, most of which cause severe illnesses,” said Saravana Kumar, a professor at the university, who is in charge of the stall. “We can scrub our vessels squeaky clean, wash the veggies several times and sanitize our hands repeatedly but the food we consume continues to be unsafe.”
    To prove his point, Kumar dissolved some jaggery bought from a grocer in water and added a drop of cleaning acid. Immediately, it precipitates and rises. “Detergent is mixed with jaggery to provide bulk. This could cause serious stomach disorders,” he said.
    Doctors say adulterated food is a menace but cannot be curtailed as people are dependent on packaged food products sold in stores. “Additives, artificial colours and products that enhance texture and flavour will cause damage to the body in the long run. If a person is suffering from a
heart or kidney ailment, it will
exacerbate the problem,” said Dr
N Kathiresan from Cancer Institute. “From increased blood pressure to cancer, a range of health problems can be traced to adulterated food,” he said.
    Even vegetables contain harmful chemicals in excess of the permissible limits prescribed by the Food Safety and Standards Act, he said and suggested that people go organic.
    “People should have gardens at home and grow their own vegetables. It can not only be a relaxing hobby but also save time and money and
ensure good health,” he said.
    janani.sampath@timesgroup.com 

Food safety law

The High Court on Thursday ordered issue of notice to the Food Safety and Standards Authority of India, New Delhi, in connection with a petition filed by the Karnataka Pradesh Hotel and Restaurants Association.

The association has questioned the regulations and some of the provisions of the Food Safety and Standards Act, 2006, which were enforced from August 2012, replacing the Prevention of Food Adulteration Act, 1954.

The High Court, in July 2013, issued an interim order staying the regulations and the provisions. Justice A.N. Venugopala Gowda ordered issue of notice to the authority as the Union government pointed out that the authority was a necessary respondent for adjudicating the plea. Meanwhile, the court extended the interim order until next date of hearing.

HC notice to food authority

The high court has ordered notice to Food Safety and Standards Authority of India, New Delhi, in connection with a petition filed by Karnataka Pradesh Hotel and Restaurants Association.

Justice AN Venugopala Gowda also extended the stay till the next date of hearing with regard to certain guidelines under Food Safety and Standards Regulations, which are under challenge.

The petitioner has challenged regulations related to licencing, packaging, labelling and registration. It claims a hotelier cannot be expected to test around 150 insecticide residues in the hundreds of items prepared. It also states the Rs 12-lakh ceiling imposed on petty food manufacturers is unrealistic.

Registration of food businesses a must

KOHIMA: All food business operators (FBOs) in Nagaland, irrespective of whether they are based in urban or rural areas, have been directed to obtain licenses and register their businesses under the Food Safety and Standards Act, 2006, before February 4, 2014.

Neiphi Kire, principal director and additional food safety commissioner, directorate of health and family welfare, Nagaland, said, "Operating a food business without a license or registration will attract penalty up to Rs 5 lakh and imprisonment up to six months under Section 63 of the Food Safety and Standards Act, 2006."

According to the Act, all FBOs should be registered with the Food Safety and Standards Authority of India (FSSAI) and obtain licenses. FBOs includes hotels, permanent and temporary stall owners, hawkers, home-based canteens, dhabawalas, food manufacturers, processors, re-packers, food stall arrangements in religious gatherings, slaughterhouses, storage houses, retail and wholesale traders, hostels, packaged drinking water units and so on.

Kire further said that all food businesses dealing in sales, storage and distribution of local food products and homemade food have been directed to properly seal the products in food grade plastic containers or polyethylene. The product seal should carry the following information on the label: name of food; date of manufacturing or packing; ingredients; net weight, volume; lot number, batch number, code number; best before date; use by date and expiry date.

"Non-compliance to this directive would be an offence punishable under the said Act and rules," Kire said in the press release. The measure will help the FSSAI protect and promote public health through regulation and supervision of food safety.

Food Business Operators (FBOs) in Nagaland directed to register their business

TNT News Kohima: It is informed that all food business operators (FBOs) in Nagaland have been directed to obtain licenses and register their businesses under the Food Safety and Standards Act, 2006, before February 4th, 2014. Neiphi Kire, principal director and additional food safety commissioner, directorate of health and family welfare, Nagaland, said, “Operating a food business without a license or registration will attract penalty up to Rs 5 lakh and imprisonment up to six months under Section 63 of the Food Safety and Standards Act, 2006.”

According to the Act, all FBOs should be registered with the Food Safety and Standards Authority of India (FSSAI) and obtain licenses. FBOs includes hotels, permanent and temporary stall owners, hawkers, home-based canteens, dhabawalas, food manufacturers, processors, re-packers, food stall arrangements in religious gatherings, slaughterhouses, storage houses, retail and wholesale traders, hostels, packaged drinking water units and so on. “Non-compliance to this directive would be an offence punishable under the said Act and rules,” Kire said.

NGT’s directive to FSSAI

The National Green Tribunal (NGT), Southern Bench, on Thursday directed the Food Safety and Standards Authority of India (FSSAI) to consider the applications of flavoured water manufacturing units for the grant of licenses to them within a month.

Last March the tribunal took suo motu cognisance of a news report highlighting violations of certain norms by packaged water drinking units. Pursuant to a direction of the tribunal, all flavoured units were closed by the Tamil Nadu Pollution Control Board for want of license from the FSSAI. Hence, International Herbal Water Foundation and others filed appeals challenging the closure orders.

In an earlier hearing, the TNPCB said the units should get the licences from the FSSAI before obtaining consent from the TNPCB. Hence, the tribunal directed the FSSAI to consider the applications for licences within two weeks. When the matter came up for hearing before the Bench comprising Justice M. Chockalingam and Prof. R. Nagendran on Thursday, the counsel for FSSAI sought time to process applications.