Dinesh Kamath's column 'Inside Navi Mumbai (12) (Remarkable performance by FDA)' that was published in Newsband

Inside Navi Mumbai

By Dinesh Kamath

Remarkable performance by FDA

The Food and Drug Administration (FDA) is an agency which is responsible for protecting and promoting public health through the regulation and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals etc.

In recent years, the agency began undertaking a large-scale effort to consolidate its operations.

FDA has a staff which inspects production and warehousing facilities, investigate complaints, illnesses, or outbreaks, and review documentation in the case of medical devices, drugs, biological products, and other items where it may be difficult to conduct a physical examination or take a physical sample of the product. Though samples are usually food-related, some laboratories are equipped to analyze drugs, cosmetics, and radiation-emitting devices.

For example, the FDA regulates almost every facet of prescription drugs, including testing, manufacturing, labeling, advertising, marketing, efficacy and safety.

Beginning November 2011, Food and Drugs Administration (FDA), Konkan Division, has till December 2012, registered record revenue worth Rs 11,93, 78,  600 through collection of registration and licence fees from shops and commercial establishments dealing  wit h consumable products, under its purview in Konkan region including Thane city and Navi Mumbai. This is a remarkable performance.

The amount has been accrued in the form of issuance of 19,822 food licences and registration of 21,755 small traders and vendors. Navi Mumbai chipped in major share in earnings from penalty, registration and licence fees.

Apart from this, FDA special squads cracked on 21 cases found to be running business sans registration and collected a big fine amount. Besides, a huge amount has been collected from licence holders for publicizing unethical advertisements to market their goods and selling of products with contradictory labels, risking the lives of consumers.

MotherDairy, Navi Mumbai was found to be the biggest defaulter that held responsible for misleading the people with wrong advertisements. The firm was fined.

FDA, Maharashtra had done a great job by making the licensing and registration available both online and by manual process. This department has gone out of the way to make the licensing and registration process uncomplicated and mandatory.

The centralized service of registration and issuance of license that came under one umbrella in the FDA was introduced in Mumbai, Thane and Navi Mumbai on experimental basis which later expanded to other areas in the state, scrapping the old system of separate licensing authorities for different business. But it worked in the later part when FDA officials embraced one to one contact with the trading fraternity.

Initiation of conducting regular awareness camps, seminars and workshops at various locations yielded rich harvest as a result of which more shops, hotels, restaurants, outlets have been registered under FDA.

With around 45 lakh food establishments across Maharashtra, the FDA has insisted that not only restaurants and hotels but even roadside food vendors must apply for a valid licence.

It is usually the small shops and vendors that pose a problem in terms of licence. As per the Food Safety and Standards Authority of India (FSSAI), anybody involved in the sale of consumables should have a valid licence and be registered with the FDA.

Having a valid licence is important not only to comply with the norms but also to keep a tab on the hygiene levels practised by food vendors.

FDA inspectors have also been interacting with the food business operators to ensure that the establishments have the appropriate license or certificate.

As per the FSSAI Act, establishments with an annual turnover of Rs 12 crore should own a licence while those with less turnover should have a certificate.

In the tussle of obtaining licences, the consumer suffers the most as he is deprived of purchasing quality products from a convenient store if it is not licensed.

In the recent times, adulterated drugs were found in the market. FDA should impose penalties to the interstate marketing of "adulterated" drugs, and the standard of strength, quality, or purity of the drugs should be tested.

FDA should try and stimulate and facilitate a national effort to modernize the sciences through which FDA-regulated products are developed, evaluated, and manufactured.

Critics of the FDA's regulatory power argue that the FDA takes too long to approve drugs that might ease pain and human suffering faster if brought to market sooner. There has also been a call for more robust and enduring reforms that would allow patients, under the care of their doctors, access to drugs that have passed the first round of clinical trials.

There was a case in America. The widely publicized recall of Vioxx, a non-steroidal anti-inflammatory drug now estimated to have contributed to fatal heart attacks in thousands of Americans, played a strong role in driving a new wave of safety reforms at both the FDA rulemaking and statutory levels. Vioxx was approved by the FDA in 1999, and was initially hoped to be safer than previous NSAIDs, due to its reduced risk of intestinal tract bleeding. However, a number of pre-and post-marketing studies suggested that Vioxx might increase the risk of myocardial infarction, and this was conclusively demonstrated by results from the APPROVe trial in 2004. Faced with numerous lawsuits, the manufacturer voluntarily withdrew it from the market. The example of Vioxx has been prominent in an ongoing debate over whether new drugs should be evaluated on the basis of their absolute safety, or their safety relative to existing treatments for a given condition. In the wake of the Vioxx recall, there were widespread calls by major newspapers, medical journals, consumer advocacy organizations, lawmakers, and FDA officials for reforms in the FDA's procedures for pre- and post- market drug safety regulation.

FDA in India too should remove deficiencies in the current FDA system for ensuring the safety of drugs in the Indian market. There should be an increase in the regulatory powers, funding, and independence of the FDA. All the drugs prescribed for children particularly should be tested for safety or efficacy in a pediatric population.

Thus there is a great scope to improve the functioning of FDA in India. Indian and Maharashtra governments should study the functioning of FDA in the United States of America and accordingly bring about reforms in the way FDA in India functions.