Must Read Article: PHARMA, JOURNEY TO……. JAIL

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About Author:
Mr. Jagmohan Rai Agarwal,
M.Pharm (1968), Industrial experience SSI sector, nearly 37 years, retired from own Industry,
Founder President of M.P.Pharmacy Graduates’ Association,
President: M.P.Pharmaceutical Manufacturers’ Organisation,
Founder President : M.P. Small Scale Drug Manufacturers’ Association,
President Indian Pharmaceutical Association, M.P. State Branch, Indore,
Recently submitted thesis for award of  Ph.D. on title “Enforcement of Drug Laws-Globalization vis-à-vis Indian Drug Laws”

Quality of Pharmaceuticals has been a concern of the World Health Organisation (WHO) since its inception. The setting of global standards is requested in Article 2 of the WHO constitution which sites as one of the organisation’s functions that it should develop, establish and promote International standards with respect to food, biological, pharmaceuticals and similar products.

Campbell (US FDA) was the first leading architect of the present Federal Food, Drug and Cosmetics Act passed in 1938. He differed sharply with ‘Willey’ in his belief that Court proceedings were not the only proper way to secure compliance.

A simple broad definition of “regulation” is ‘the use of public authority to set and apply rules and standards’ in an attempt to “manipulate prices, quantities ( and distribution ), and quality of products” These types of legal and administrative restrictions are only fully successful in the context of a well-resourced regulatory framework e.g. both for implementation and monitoring as well as the existence of a well-functioning judicial system (for enforcement and sanctioning). Governmental regulation is inherently a creature of the political process so that changes at the level of a drug regulatory authority often require difficult negotiations.

In 1911 U. S. v/s Johnson, the Supreme Court ruled that the 1906 Food and Drugs Act does not prohibit false therapeutic claims but only false and misleading statements about the ingredients or identity of a drug, this ruling was overcome by Sherley amendment in 1912. In 1930 the name food, drug and insecticide Administration shortened to Food and Drug Administration (FDA)

1937 Elixir of Sulphonamide containing poisonous solvent diethyl glycol kills 107 persons, dramatizing the need to establish drug safety before marketing and to enact the pending Food and Drug Law.

The Federal Food, Drug and Cosmetics (FDC) Act passed in 1938 and Walter G. Campbell was appointed the first Commissioner of Food and Drug. In the year 1962, after ‘Thalidomide’, a sleeping pill, tragedy, found to cause birth defects in Western Europe, the drug manufacturers were required to prove to FDA the effectiveness of their products before marketing them.

A regulation is neither efficient nor effective if it is not complied with or can not be effectively enforced. A policy instrument that appears effective may be difficult to implement. Indeed, many countries may promulgate regulations that go beyond the capacity of their compliance and enforcement capabilities. For developing countries, simpler operational structures for drug registration and quality control testing of pharmaceuticals are likely to be more appropriate than complex structures and therefore, ‘appropriate regulatory’ technology is strongly recommended. It should be the goal of any developing country to create a pharmaceutical regulatory administrative system that is transparent, not overly legalistic, not too expensive to administer, that can not be easily manipulated, either from within or without, and that has regulations that can actually be enforced. Therefore, Drug Regulatory Authorities of developed countries are not necessarily models to emulate in the short (or even the long) term. For instance, legal sanctions such as barring a product from being sold or advertised that can be sued by the U.S. FDA may not be feasible in developing countries that lack regulatory and legal enforcement

The standards for drug review and approval in U.S. are the Best in the world and the safety of drug supply mirrors these high standards.

In Australia Regulatory framework is based on a risk management approach designed to ensure public health and safety and while at the same time freeing Industry from any unnecessary regulatory burden. TGA has developed constructive partnership with Industry

In developed countries and some of the developing countries civil/financial penalties instead of criminal prosecution is preferred for violation of Law. Whereas in India law is being enforced under the threat of Departmental action (Suspension or Cancellation of Licences) and/or criminal prosecutions. The basis of all these actions is test reports of Government laboratories either under provincial or Central Government control. The status of these laboratories, in majority cases, is not better than a mismanaged grocery/ kirana shop. The concerned Regulatory Authority prefers to keep himself free of controversies and allegations of not taking action which results in a short cut by proposing either departmental or criminal prosecution and shoulder is changed.

Availability of Safe, Efficacious and Quality drug formulations at affordable price is the centre point of ‘Regulatory Laws’ in the world. The degree of its ENFORCEMENT and PENALTIES for violations differs from country to country. Misbranded, Adulterated, Spurious/Counterfeit, Not of Standard Quality/Sub potent medicines and high prices are mainly due to improper enforcement of Regulatory Laws.

There are many ways to write FDA’s history. It can be a story of laws which Governments’ enact, a story of famous cases to enforce those laws, a story of the organization and the people who built it, or a story about the changing technology and the scientific controversies, some settled others still unsolved. And it can be all of these but not in a few pages.

If there is one dominating theme it is the change from a law, that was primarily a criminal statute protecting customers through the deterrent effect of court proceedings to a law that is now dominantly through informative regulations and pre-market controls.

India is probably the only country in the world where a State Regulatory Association filed a petition before High Court seeking direction to the State Government to fill up the vacancies of regulatory officials in the department. India is again probably the only country where the Government and/ or Regulatory Authorities are clearly violating provisions of the ‘Act’ and ‘Rules’ without any accountability.

To make the provisions of Law effective, it’s proper, timely and unbiased Enforcement must be the only motto. Making laws more and more stringent does not serve the purpose. The recent amendment ( year 2009) in the Indian Drugs and Cosmetics Act, enhancing punishments to violators of the Law, is like “handing over loaded machine guns in the hands of monkeys”, commented an Ex Head of a State Drug Regulatory Department. Like China, let there be accountability of Enforcement Agency especially in India.



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