More recently, allegations of widespread fraud in relation to generic drugs produced in many countries, especially India, have been in the spotlight in the US. The discussion proceeded due to a special mention of contamination present in a drug manufactured by the Ranbaxy company. Of course, this malicious practice of Ranbaxy cannot be endorsed but at the same time the importance of ongoing efforts to improve India’s drug regulatory framework cannot be ignored. The US seems to be particularly focused on reducing the importance of generic drugs produced in other countries.
- After research and innovation, drugs are manufactured which are patented by the drug manufacturing company under the TRIPS method. The manufacture and sale of the drug by patent becomes exclusive to the company concerned and the manufacture of that drug is banned for any other entity.
- This patent is only possible for 20 years. To renew this patent, the drug manufacturer has to make a fundamental change in the medicine. Without it, the drug patent expires.
- After the expiry of the patent, any company or country is able to manufacture that medicine. Such drugs are called generic medicines. Often these drugs are sold without the brand name or by any other name or formula. Also, the effect and utility of these drugs are similar to those of patent medicines.
- Similarly, compulsory license is also a method in which a country can license the manufacture of any patented drug to another pharmaceutical manufacturer in the public interest, so as to reduce the price of the drug and broaden its use.Compulsory licensing has been provided in the case of Natco Company in India.
Ranbaxy events came to light 14 years ago. Since then, many pharmaceutical companies of all kinds – domestic or foreign or generic and innovative – have come under the purview of such malicious conduct. As a particular example, Martin Shkreli’s Turing Pharmaceuticals, which raised the price of a drug by 5000 percent, and Purdue Pharmaceuticals, which just recently created Opioid Crisis Convicted of doing, may be cited.
The strategy of communicating a phobia towards ‘contaminated’ foreign generic drugs has successfully led to prejudice in the minds of US citizens against legitimate generic drugs, even though these generic drugs remain a viable alternative.
This new frenzy regarding drug contamination has arisen partly due to the expansion of the Food Safety Modernization Act- FSMA which incorporates global inspections. Thus, one of the objectives of strengthening the Food and Drug Administration- FDA was to collaborate with regulators from other countries and create a current Good Manufacturing Practice- CGMP system for medicines. .
FDA Regulatory Hyperactivity
However, rather than building a co-operation and universal system, the FDA has presented itself as a ‘global regulator’. For example, in a recent statement the FDA stated that it inspects all brand names and generic manufacturing establishments worldwide based on informants’ information or concerns about drug safety. It is certainly a case of regulatory hyperactivity because no international system exists that establishes American CGMP practice as a global standard.
In addition, under the FSMA, the FDA has a very limited power to prevent the entry of drugs or food into the United States if a foreign entity does not allow its inspection. This emphasis on America’s adherence to better manufacturing practices for the safety of its citizens is commendable, but similarly India companies will oppose the move if India or China make any law and talk about inspection of American food or pharmaceutical establishments.
Of the 4,676 human drug installations inspections conducted by the FDA worldwide in the year 2018, 61 percent were inspected by foreign establishments. Similarly, 55 percent of the 1,365 human drug CGMP inspections were conducted by establishments located outside the US. The FDA’s ‘Global Vigilante Experience’ portrays drugs produced in other countries as ‘defective’ or ‘contaminated’ while not openly acknowledging regulatory barriers in the US. In this perspective, it is necessary to mention that America’s Drug Recall List is 149 pages long. This is a list of drugs that have been found to be defective while receiving FDA approval for the last 14 years. It is clear that a biased approach that does not consider all the perspectives can create a false image.
Many issues, small and large, may emerge in the inspection of production facilities conducted by the FDA. There is no measure to determine whether the problems highlighted in the final report are simple problems or complex problems (such as the use of contaminated water). The absence of a suitable scale creates a drawback where the regulator has the opportunity to select an establishment on its own and portray all instances of noncompliance as gross violations.
Also, there is no clear legal definition in the US for the term ‘Contaminated Drugs’ often used. Section 351 of heading 21 of the US Code defines adulterated drugs. When a drug is considered ‘adulterated’ to be contaminated, the regulator has to clarify to which this adulteration relates to manufacturing methods, standard packing methods, or production practices.
WTO & WHO & Generic Medicines
The World Trade Organization (WTO) is the world’s largest trade forum discussing trade related issues and policy making. Generic medicines have also been an important issue before the WTO. Often, developing and less developed countries favor generic medicines. The main motive behind this is their cheap prices. At the same time, developed countries, which are pioneers in the field of drug trade, are often seen opposing these drugs. The main reason for this is that generic medicines are available in the market at cheaper prices whereas patent medicines which are mainly produced by companies of developed countries are more expensive.
On this issue, the WTO has given exemptions for developing countries to use generic medicines and make expensive medicines available at a lower price through compulsory licensing, if required. Also, countries that are least developed, such as countries on the African continent, are allowed to import generic drugs because they are backward in the level of infrastructure and innovation and are not able to manufacture generic drugs.
In spite of all this, developed countries like America and European Union are emphasizing on the concept of TRIPS Plus. This will make the manufacture and use of generic drugs more difficult. This situation can lead to serious health crisis for developing countries and less developed countries. Also, it can also affect the affordability of health services for the poor population of different countries.
The World Health Organization (WHO) is in favor of uninterrupted movement of generic medicines in the world and considers generic medicines essential for the implementation of the right to health globally. Particularly in favor of providing medicines (AIDS, cancer) related to the protection of life at affordable prices globally.
US drug market
According to a study, the market for generic drugs in the US is over 100 billion dollars. Also, it has registered an increase of 12 percent every year for the last 6 years. It is also worth noting that large amounts of people in the US are advised by doctors to take generic medicines. 40 percent of these generic medicines are provided by Indian companies. The United States is adopting a full-fledged policy to protect its pharmaceutical industry from generic drugs. This policy of America is harmful not only for the drug trade of different countries but also for the citizens of America. It is worth noting that in the last decade, the US has saved $ 2 trillion in the health sector, which has been possible mainly due to the use of generic drugs.
For India, this ongoing discussion in the US is important not only because there are many generic manufacturing establishments in the country, but also because India stands on the cusp of being transformed into an innovative market. This would be an appropriate time for India to play a more determined role in ensuring public availability of facts, both on the importance of generic medicines and their limitations. The country needs to build strong consensus and partnership that will highlight both the benefits and the drawbacks so that a strong foundation is provided for innovation. It would not be appropriate to deny productive workforce access to life-saving drugs on the pretext of innovation and policy failures.
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