Karnataka budget 2014- Highlights

Feb 14, 2014: 

Health & Family Welfare

* Rs 5 crore for creating infrastructure for effective implementation of the Food Safety and Standards Act, 2006

Pune strictly follows food quality norms

PUNE: Adherence to food quality and fair trade practices in Pune division is the highest in Maharashtra with the Pune Food and Drug Administration (FDA) issuing maximum licenses to food product traders since the implementation of the Food Safety and Standards Act from August 5, 2011 to February 4, 2014.

In the country, Maharashtra has issued maximum licenses.

"Dealers and manufacturers trading in food products, having a turnover of more than Rs 12 lakh, need to procure licenses. If the turnover is less, then the traders need to get themselves registered with the FDA," Joint Commissioner (Food), FDA, Shashikant Kekare told Sakal Times.

According to the figures made available by FDA, Pune, nationally, 4,81,964 licenses have been issued, while 19,10,160 registrations have been completed. Out of these, the Maharashtra figures are 1,41,777 and 4,62,809 respectively. The total licenses and registrations issued by Pune FDA is 1,74,630.

"We endeavour to achieve an appropriate level of protection of human life and health and the protection of consumer's interests, including fair practices in all kinds of food trade with reference to food safety standards and practices as prescribed under the Food Safety Act," Kekare said.

The FDA Joint Commissioner said that risk assessment of food quality is undertaken periodically.

"On the basis of assessment of available, the possibility of harmful effects on health is identified. We also ensure that the measures adopted by us are reviewed within a reasonable period of time, depending on the nature of the risk to life," he said.

According to the Assistant Commissioner (Food), Dilip T Sangat, in cases where there are reasonable grounds to suspect that a food item may present a risk to human health, then, depending on the seriousness, the FDA takes appropriate steps.

LICENSES ISSUED

According to the figures made available by FDA, Pune, nationally, 4,81,964 licenses have been issued. The total licenses and registrations issued by Pune FDA is 1,74,630.                             

Medicines made in India set off safety worries in US

Ranbaxy, one of India’s biggest drug manufacturers, pleaded guilty to felony charges and paid a $500 million fine last year, the largest ever levied against a generic company. 

NEW DELHI: India, the second-largest exporter of over-the-counter and prescription drugs to the United States, is coming under increased scrutiny by American regulators for safety lapses, falsified drug test results and selling fake medicines.

Dr Margaret A. Hamburg, the commissioner of the United States Food and Drug Administration, arrived in India this week to express her growing unease with the safety of Indian medicines because of "recent lapses in quality at a handful of pharmaceutical firms."

India's pharmaceutical industry supplies 40 percent of over-the-counter and generic prescription drugs consumed in the United States, so the increased scrutiny could have profound implications for American consumers.

FDA investigators are blitzing Indian drug plants, financing the inspections with some of the roughly $300 million in annual fees from generic drug makers collected as part of a 2012 law requiring increased scrutiny of overseas plants. The agency inspected 160 Indian drug plants last year, three times as many as in 2009. The increased scrutiny has led to a flood of new penalties, including half of the warning letters the agency issued last year to drug makers.

Dr. Hamburg was met by Indian officials and executives who, shocked by recent FDA export bans of generic versions of popular medicines — such as the acne drug Accutane, the pain drug Neurontin and the antibiotic Cipro — that the FDA determined were adulterated suspect she is just protecting a domestic industry from cheaper imports.

"There are some people who take a very sinister view of the FDA inspections," Keshav Desiraju, India's health secretary until this week, said in a recent interview.

The FDA's increased enforcement has already cost Indian companies dearly — Ranbaxy, one of India's biggest drug manufacturers, pleaded guilty to felony charges and paid a $500 million fine last year, the largest ever levied against a generic company. And many worry that worse is in store.

"If I have to follow U.S. standards in inspecting facilities supplying to the Indian market," G. N. Singh, India's top drug regulator, said in a recent interview with an Indian newspaper, "we will have to shut almost all of those."

The unease culminated Tuesday when a top executive at Ranbaxy — which has repeatedly been caught lying to the FDA and found to have conditions such as flies "too numerous to count" in critical plant areas — pleaded with Dr Hamburg at a private meeting with other drug executives to allow his products into the United States so that the company could more easily pay for fixes. She politely declined.

India's drug industry is one of the country's most important economic engines, exporting $15 billion in products annually, and some of its factories are world-class, virtually undistinguishable from their counterparts in the West. But others suffer from serious quality control problems. The World Health Organization estimated that one in five drugs made in India are fakes. A 2010 survey of Delhi pharmacies found that 12 percent of sampled drugs were spurious.

In one recent example, counterfeit medicines at a pediatric hospital in Kashmir are now suspected of playing a role in hundreds of infant deaths there in recent years.

One widely used antibiotic was found to contain no active ingredient after being randomly tested in a government lab. The test was kept secret for nearly a year while some 100,000 useless pills continued to be dispensed.

More tests of hospital medicines found dozens more that were substandard, including a crucial intravenous antibiotic used in sick infants.

"Some of the fake tablets were used by pregnant women in the post-surgical prevention of infections," said Dr. M. Ishaq Geer, senior assistant professor of pharmacology at Kashmir University. "That's very serious."

Investigations of the deaths are continuing, but convictions of drug counterfeiters in India are extremely rare.

Satish Reddy, president of the Indian Pharmaceutical Alliance, said Indian drug manufacturers are better than the FDA now contends. "More rigorous enforcement is needed, for sure, but this impression that India is overrun with counterfeits is unjustified," Mr. Reddy said.

But Heather Bresch, chief executive of Mylan, which has plants in the United States and India, said regulatory scrutiny outside of the United States was long overdue. "If there were no cops around, would everyone drive the speed limit?" Ms. Bresch asked. "You get careless, start taking risks. Our government has enabled this."

For Dr. Hamburg, the trip is part of a long-running effort to create a global network of drug and food regulators to help scrutinize the growing flood of products coming into the United States, including 80 percent of the seafood consumed in the United States, 50 percent of the fresh fruit, 20 percent of the vegetables and the vast majority of drugs.

She has gone to conclaves of regulators from Europe and elsewhere to coordinate policing, but Indian officials have so far not attended such meetings.

Many of India's drug manufacturing facilities are of top quality. Cipla, one of the industry's giants, has 40 plants across the country that together can produce more than 21 billion tablets and capsules annually, and one of its plants in Goa appeared just as sterile, automated and high tech on a recent tour as those in the United States.

Cipla follows FDA guidelines at every plant and on every manufacturing line, and the company exports more than 55 percent of its production, said Yusuf Hamied, the company chairman.

But Benjamin Mwesige, a pharmacist at the Uganda Cancer Institute in Kampala, said in an interview in July that the institute had stopped buying cancer drugs from India in 2011 because it had received shipments of drugs that turned out to be counterfeit and inactive, with Cipla labels that Mr. Mwesige believed were forged.

He became suspicious when doctors began seeing chemotherapy patients whose cancer showed none of the expected responses to the drugs — and who also had none of the usual side effects. The drugs that had been prescribed were among the mainstays of cancer treatment — methotrexate, docetaxel and vincristine. Laboratory tests confirmed that the drugs were bogus, and Mr. Mwesige estimated that in 2011 about 20 percent of the drugs that the institute bought were counterfeit.

Enforcement of regulations over all is very weak, analysts say, and India's government does a poor job policing many of its industries. Last month, the United States Federal Aviation Administration downgraded India's aviation safety ranking because the country's air safety regulator is understaffed, and a global safety group found that many of India's best-selling small cars are unsafe.

India's Central Drugs Standard Control Organization, the country's drug regulator, has a staff of 323, about 2 percent the size of the FDA's, and its authority is limited to new drugs. The making of medicines that have been on the market at least four years is overseen by state health departments, many of which are corrupt or lack the expertise to oversee a sophisticated industry. Despite the flood of counterfeit drugs, Mr. Singh, India's top drug regulator, warned in meetings with the FDA of the risk of overregulation.

This absence of oversight, however, is a central reason India's pharmaceutical industry has been so profitable. Drug manufacturers estimate that routine FDA inspections add about 25 percent to overall costs. In the wake of the 2012 law that requires the FDA for the first time to equalize oversight of domestic and foreign plants, India's cost advantage could shrink significantly.

Some top manufacturers are already warning that they may leave, tough medicine for an already slowing economy.

"I'm a great nationalist, an Indian first and last," Dr. Hamied said. "But companies like Cipla are looking to expand their businesses abroad and not in India."

American businesses and F.D.A. officials are just as concerned about the quality of drugs coming out of China, but the F.D.A.'s efforts to increase inspections there have so far been frustrated by the Chinese government.

"China is the source of some of the largest counterfeit manufacturing operations that we find globally," said John P. Clark, Pfizer's chief security officer, who added that Chinese authorities were cooperative.

Using its new revenues, the F.D.A. tried to bolster its staff in China in February 2012. But the Chinese government has so far failed to provide the necessary visas despite an announced agreement in December 2013 during a visit by Vice President Joseph R. Biden Jr., said Erica Jefferson, an FDA spokeswoman.

The United States has become so dependent on Chinese imports, however, that the FDA may not be able to do much about the Chinese refusal. The crucial ingredients for nearly all antibiotics, steroids and many other lifesaving drugs are now made exclusively in China.

Denise Grady contributed reporting from Kampala, Uganda, and Hari Kumar from Srinagar, Kashmir.

Delhi food safety commissioner's claim on FBO licence conversion false

There is no truth to Delhi’s food safety commissioner K J R Burman’s claim that food business operators (FBO) in the capital got 2,500 licenses converted before the February 4, 2014 deadline lapsed. This was stated by the Food Safety and Standards Authority of India (FSSAI), the country’s apex food regulator.

Only 645 licenses have been obtained so far, while the process of registration is yet to commence. In fact, it has been sluggish since August 5, 2011, the date the Food Safety and Standards Act (FSSA), 2006, came into effect. It is, however, expected that the capital would be on track by the time the extended deadline - August 4, 2014 - lapses.

Sources stated that the Mayur Bhavan office, where the registration and licensing would take place, was to be ready by April 2013, but it remains incomplete.

Only the Andaman and Nicobar Islands (331); Dadra and Nagar Haveli (200); Daman and Diu (258); Manipur (394); Meghalaya (633); Mizoram (228); Nagaland (160); Puducherry (332) and Sikkim (360) have issued fewer licences than Delhi.

CAT order to UT on food safety officer’s plea for appointment

Chandigarh, February 14

In an order passed today, the Central Administrative Tribunal (CAT) today directed the UT Administration to consider the UT’s senior-most food safety officer for appointment as designated officer under the Food Safety and Standards Act and fill the post on a regular basis in three months than filling it by way of deputation. 

The CAT disposed of the application filed by Food Safety Officer Sukhwinder Singh, who had moved the tribunal in 2011, seeking direction to the UT administration for considering him for the post. He had challenging the UT Administration move to fill the post by way of deputation.

Singh had claimed that he was the senior-most food safety officer, thus was eligible to be appointed a designated officer under the Food Safety and Standards Act.

In his application in September 2011, He had submitted: “The post of designated officer is being occupied by an official who has come on deputation, in addition to his own duties. He is on deputation for medical services as SMO from Haryana whereas as per the Act and rules, a whole-time officer is required to be appointed designated officer for performing duties under the Food Safety and Standards Act, 2006, and the rules framed thereunder in 2011.”

About a shared vision on safety issues

The US FDA commissioner posts on food and medical products during a visit to India 

Fresh mangoes, bananas and other native fruits add a pop of colour and provide the backdrop while we ride along the busy streets of Delhi. 

While en route to the first of several meetings I held with Indian regulators, I can’t help but marvel at the vibrant buzz of India’s capital and the progress that has been made since I travelled here years ago as a young woman. 

The partnership

Since that time, the rapid globalisation of commerce has posed significant challenges to ensuring consumer safety as the number of products and suppliers entering the US has increased. 

India now represents the third largest trade partner, second largest supplier of over-the-counter and prescription drugs, and eighth largest supplier of food to the US. 

On Monday, I began my first official visit to the country as commissioner of the US Food and Drug Administration. 

I met with officials from the Indian government who oversee the country’s health-related matters as well as those responsible for overseeing the export of foods to the US and more than 200 countries around the world. 

These meetings provided the opportunity to discuss our shared vision for strengthening the quality of the foods and medical products exported from India to the US. 

Ultimately, this vision is intended to enhance consumer confidence in these products both at home and abroad. 

Top priority

As two of the largest democracies in the world, our countries have enjoyed an enduring partnership and commitment to collaborate on initiatives designed to enhance both our economies and the lives of the people in our respective countries. 

Ensuring that the products distributed in the US meet our requirements for product safety and quality is among my top priorities. 

Unfortunately the many Indian companies that understand good manufacturing and quality processes have been overshadowed by recent lapses in quality at a handful of pharmaceutical firms. 

While the FDA will take appropriate action against any company that doesn’t meet our requirements, we are also willing to work with them to address their issues. All consumers deserve access to safe and affordable drugs and should not have to sacrifice quality to get that. 

Working together

Officials at India’s Ministry of Health and Family Welfare share this goal. In the spirit of continued collaboration and a commitment to quality, our agencies signed the first-ever Statement of Intent. 

Our organisations plan to collectively work together to improve the lines of communication between our agencies and work diligently to ensure that the products being exported from India are safe and of high quality. 

While the Statement of Intent is an important milestone, I am proud to report that FDA’s office in India has already been working closely with India’s drug regulators to reinforce the importance of producing quality products for patients. 

Secure access

Drug and food regulators in India have participated in FDA-hosted workshops and observed FDA inspections of manufacturing facilities and clinical sites with operations in India. 

During my visit I am eager to learn more about the industries that produce products for the US and to meet with business leaders where I will reinforce our expectations that they meet our requirements for ensuring that consumers here and around the world have access to safe and high-quality products. 

(This article was first published as a blog post on FDA Voice)