Needed a truly independent food and drug regulatory commission

Regulation of food in the United States dates from early colonial times. Federal controls over the drug supply began with inspection of imported drugs in 1848.

In Bangladesh too, the journey began with the Bangladesh Pure Food Ordinance, 1959. LGRD and Cooperatives Minister Abdul Mannan Bhuiyan, who is also the ruling party secretary general, tabled a bill titled: Bangladesh Pure Food (Amendment) Act 2005 in parliament on September 13, seeking to amend this ordinance.

The proposed amendments include, among other things, punitive fines ranging from Taka 75,000 to 300,000, coupled with rigorous imprisonments ranging from one to three years. It also provides for forfeiture of shops or factories, including assets, to the government or to the local government authorities. The proposed act encompasses a number of acts and intentions relating to food and food-related substances. It also proposes formation of "pure food court" and "national food safety advisory council." The good intentions of the government are clear from the introductory speech of the minister.

The concern and interest of the general people in securing food and drug safety is manifest from media reports and coverage of the ongoing drive against adulterers. Most newspapers covered the introduction of the bill as their main news. It is, therefore, pertinent to analyse and evaluate the proposed bill to see if it will serve the intended purpose or not. This is more so in view of the recent experiences of similar government initiatives. Moreover the penalties proposed are too meager, these are no real deterrents.

The plight of existing regulatory bodies are cases in point. Bangladesh Telecommunication Regulatory Commission (BTRC), Anti-Corruption Commission (ACC) and the Bangladesh Energy Regulatory Commission (BERC) were all formed by the incumbent government. These statutory bodies were formed with good intentions no doubt, but all of them are practically non-functional. That definitely was not intended, yet the end results are similar in all the three cases.

BTRC is now almost four years old. Even today it is not fully functional. Positions of commissioners are vacant for long, it does not have its own manpower, people on deputation from other departments are guests waiting to return home. The commission does not have recruitment authority, nor does it have its own budget or budgeting authority. Similar story can be told of the other commissions, who are supposed to be independent. The less is said about the ACC the better. The other day this scribe went to the newly formed BERC. What a pitiable situation to behold! Out of five members, only three are in place, no manpower, some even do not have telephones.

Historically, inter-ministerial committees do not seem to work in this country. Some of these committees never sat even once after their formation. There are numerous such examples around us. The boards of important organisations like BOI, Privatisation Board, BEPZA, etc do not sit regularly. Even within the same organisation, the right hand does not seem to know what the left hand is doing. The debacle with the recent enhancement of hospital charges is a case in point. Recently this scribe went to a social function where most attendees were senior functionaries of the Ministry of Power, PDB, and DESA. The messages I got were 'nobody cares' and 'mark time.' Is that what is to expect of our administration?

Our constitution guarantees protection of certain fundamental rights for the citizens. Pure food and pure drugs are such rights, among more important ones of course. While any attempt to improve upon the current deplorable situation is welcome, this is also the most appropriate time to do our homework right and not repeat the misfeasance of recent times.

The proposed "national food safety advisory council" will be headed by the LGRD minister himself and will have representation from the ministries of agriculture, commerce, food and natural disaster management, health and family welfare, industry, environment and forest, home affairs, fishery and livestock, and establishment.

Additionally DC Dhaka, DG of BSTI, two Dhaka University teachers, and a representative from FBCCI will also be members. It does not require a genius to see that the council is a non-starter. While the concept of "pure food court" is an excellent interim solution, a long term solution has to be formulated soon. For this we don't need too much homework. Successful examples are aplenty. Let's look at US FDA, the most prominent of such regulatory bodies, as an example.

The original Food and Drugs Act was passed by Congress on June 30, 1906, and signed by President Theodore Roosevelt. It prohibited interstate commerce in misbranded and adulterated foods, drinks and drugs.

The Meat Inspection Act was also passed the same day. Shocking disclosures of unsanitary conditions in meat-packing plants, the use of poisonous preservatives and dyes in foods, and cure-all claims for worthless and dangerous patent medicines were the major problems leading to the enactment of these laws.

In 1952 FDA consumer consultants were appointed in each field district to maintain communications with consumers and ensure that FDA considers their needs and problems.

Consumer Bill of Rights was proclaimed by President John F. Kennedy in a message to Congress in 1962. Included were the right to safety, the right to be informed, the right to choose, and the right to be heard.

Fines Enhancement Laws of 1984 and 1987 amended the US Code to greatly increase penalties for all federal offenses in 1984. The maximum fine for individuals is now $100,000 for each offense and $250,000 if the violation is a felony or causes death. For corporations, the amounts are doubled.

Food and Drug Administration Act of 1988 officially establishes FDA as an agency of the Department of Health and Human Services with a Commissioner of Food and Drugs appointed by the President with the advice and consent of the Senate, and broadly spells out the responsibilities of the Secretary and the Commissioner for research, enforcement, education, and information.

In 2003 the National Academy of Sciences released: Scientific Criteria to Ensure Safe Food, a report commissioned by FDA and the Department of Agriculture, which buttresses the value of the Hazard Analysis and Critical Control Point (HACCP) approach to food safety already in place at the FDA and invokes the need for continued efforts to make food safety a vital part of our overall public health mission.

Formation of the Drug Safety Board was announced in 2005, consisting of FDA staff and representatives from the National Institute of Health and the Veterans Administration. The Board will advise the Director, Center for Drug Evaluation and Research, FDA, on drug safety issues and work with the agency in communicating safety information to health professionals and patients.

Today FDA regulates
- Food: Foodborne Illness, Nutrition, Dietary Supplements, etc.
- Drugs: Prescription, Over-the-Counter, Generic, etc.
- Medical Devices: Pacemakers, Contact Lenses, Hearing Aids, etc.
- Biologics: Vaccines, Blood Products, etc.
- Animal Feed and Drugs: Livestock, Pets, etc.
- Cosmetics: Safety, Labeling, etc.
- Radiation-Emitting Products: Cell Phones, Lasers, Microwaves, etc.
- Combination Products

The above illustrates the evolution that made the FDA of today. We are fortunate that we do not need to reinvent the wheel. Following good examples is a praiseworthy idea. From the US FDA example one can instantly infer that the proposed Bangladesh Pure Food (Amendment) Act 2005 is inadequate and would not serve the intended purpose because:
- LGRD Ministry is the wrong anchor;
- The proposed penalties are too small;
- It does not differentiate individual proprietary offenders and corporate offenders;
- Too many "chiefs" will be involved with too few "Indians" to administer the act;
- Cosmetic and toiletry products are not covered;
- Radiation emitting products like mobile phone, etc are not covered; and
- Possibility of conflict with the Department of Drugs Administration.

What the country needs is enactment of an all-embracing law covering food (including animal food), drugs (including herbal, homeopathic, livestock, etc), cosmetics, and toiletries, under the control of a truly independent (including budgetary, hiring and firing independence) regulatory commission. This is the right moment. Let our legislators give this proposal a good look.

AKM Shamsuddinis a former President, FICCI.