Saturday, August 3, 2019

GENERIC DRUGS: NEEDS AND REGULATION



Tylenol is brand name drugs produced by Johnson & Johnson containing acetaminophen. The cost of Tylenol (extra strength, 100 tablets) is $9.49 whereas acetaminophen (extra strength, 100 tablets) is $2.39. Similarly, the price of Allegra (180 mg, 30 tablets) is $17.99 whereas Fexofenadine (180 mg, 30 tablets) costs $11.99. This is an example of significant change in price for brand drug and its generic counterpart. With the availability of generic drugs, the price drops in 'scalloped curve' fashion. According to Food and Drugs Administration (FDA), Generic drugs are typically 80 -85 % cheaper. This is the reason, countries promotes generic drugs. At the same time, a number of evidences are suggesting that qualities of Generics is being compromised significantly because of aggressive marketing.  

             What are Generic Drugs  

Generic drugs are carbon copy of marketed brand drugs. These are manufactured by any pharmaceutical company by  ensuring that the drug has same chemical constituent, dose & dosage, therapeutic indications, pharmaceutical characteristics, side effects and safety profile with the marketed patent/brand name drugs. Even before getting approval for marketing, generic manufacturer should submit Bio-equivalence study report with the branded one to the regulatory authority of respective country. Many countries including US and India are promoting and regulating production of generic drugs within their own country, to make healthcare affordable to public. Adopting generic drugs for healthcare system might be more important to developing countries with growing health economy.

Global Market for Generics is in Boom



According to BCC Research report 2017, the global market for generic drugs is going to be $474 billion by 2023 from $315 billion (2016), with annual growth rate of 6.8 % during 2018-2023.
Increase in healthcare cost is global burden. Members of OECD (organization for economic co-operation and development) expenses 1.5 % of total GDP only in pharmaceutical products. Till now, generic substitution is found one better method to reduce this cost globally. 
The spectrum of therapeutics covered by generic drugs will be antibacterial, antidepressant, anticancer agents, antiarthritics, cardiovascular drugs and drugs for respiratory diseases. Cardiovascular medications particularly has highest market share because of increasing cardiovascular diseases secondary to changes in lifestyle and eating habit.
Generally pharmaceutical companies spent huge amount of money (in millions) to conduct innovation, discovery, experiments and humans to trials during its development. Also they have to go through vigorous regulatory procedure to get approval for marketing for future use. On contrary, generic drugs are exempt form research and human trial since, they are copied of already marketed one. Regulatory process is also undemanding for them. Food and drugs administrations (FDA) has developed ANDA (abbreviated new drugs application ) in place of NDA, abbreviated because no safety data are need to be submitted.
In 2018 only, the food and drug’s administration of united states approved more than a 1,000  new generic drugs products. Nearby 40 % of all generic drugs available in US market are imported from India, 80 % of active ingredients for both brand and generic drugs come from abroad, India and china majorly.
America makes almost none of its own antibiotics anymore.
They are less expensive, easily available and aggressively marketed. So, people form marginalized community and low socioeconomic status also can afford it.
Generic drugs by competing with branded counterparts, helps to reduce the overall healthcare cost through the globe.
Positive outlook for drugs manufacturer in terms of economic return is catalyzed by increase in prevalence of chronic diseases like: diabetes, hypertension, Alzimer  disease, depression etc. in developed as well as developing countries.

Branded drugs are patented only for certain time limit (generally for 20 years). The space for future marketing for generics has already been established; no need of investment on extensive marketing research. 

Promotional strategy for Generic Uses

Governmental healthcare centers and community hospitals can adopt certain promotional strategies to adopt generic drugs (for both in-patient as well as outpatient), which will help to increase the usage percentage as well as decrease in hospital cost. Study conducted in Gifu municipal hospital, Japan shows that adoption of generic drugs by Hospital increases its use by 9.4% within 1 year time period, The same study found that the dispensing rate as well as price percentage of generic drugs were increased significantly after the adoption. 
The price is variable upon countries to countries, but follows the same pattern while comparing developed versus developing world. The number of factors affect the price determination but, medicine supply chain system and Taxation of that particular country plays the major role. 

Generic manufacturers are misleading scientific and Regulatory community


Although generic manufacturers show Bio-equivalence study report with the patented drugs and get approval, only Bio-equivalence study can’t conform therapeutic range and safety. Specially for drugs with narrow therapeutic index, more evidences are required.
In contrary to general belief of reducing health care price with generic drugs, systematic review on impact of generic substitution on health outcome and economics shows 64% of comparison of economic outcomes suggesting cost to be lower when using original drug. Same study shows 67 % of clinical outcome being similar with the original one.
There is paucity of evidence on effects of generic drugs as de novo therapy for treatment, rather most of uses are confined on substitution therapy from original drugs.

With the massive increase in monetary value, the risk of falsification on data and compromising the quality is also high. This not only jeopardizes the health of consumers but also company’s own market get toppled, once exposed. According to NEW YORK TIMES opinion article by Eban Cathrine published on 11of may 2019, most of generic manufacturers of India supplying drugs to US do not follow industry standard “GOOD MANUFACTURING PRACTICE” and quality is severely compromised. But the regulators are fooled with the falsified and fraud data. Here I have attached small fraction of article as it was

Here I have attached small fraction of article as it was:
Six months into his stint, Mr. Baker visited a plant in Aurangabad run by the Indian company Wockhardt, which made about 110 generic-drug products for the American market. He had one week at the plant to ensure that it complied with the F.D.A. regulations known as “current good manufacturing practices.” Generating and preserving data at each manufacturing step is crucial to those regulations.
On his second day at the Wockhardt plant, Mr. Baker and a colleague caught an employee trying to smuggle out a garbage bag of documents. The documents led Mr. Baker to discover that the plant had knowingly released into Indian and other foreign markets vials of insulin containing metallic fragments. These had apparently come from a defective sterilizing machine. He learned that the company had been using the same defective equipment to make a sterile injectable cardiac drug for the American market. The willful deception there and at other plants so shocked him that he overhauled his inspection methods, with significant results.
Two months after Mr. Baker’s Wockhardt inspection, the F.D.A. banned the import of drugs from that plant into the United States, a potential $100 million loss in sales for the company. Company officials declined to comment on the fallout from the inspection.
Mr. Baker kept digging. Over the next five years, first in India and then in China, he uncovered fraud or deceptive practices in almost four-fifths of the drug plants he inspected. Some of the plants used hidden laboratories, secretly repeated tests and altered results to produce fake data that fundamentally misrepresented drug quality, then submitted that data to regulators.
In some instances, deceptions and other practices have contributed to generic drugs with toxic impurities, unapproved ingredients and dangerous particulates reaching American patients. Some doctors have struggled to stabilize patients who became sicker after they were switched from a brand-name to a generic, or between generic versions. A low-cost drug is not a bargain if it doesn’t work... (for full article, link is attached below)
 This above mentioned fraudulent issue is not only because of lack of professionalism in Indian pharmaceutics but also due to poor regulatory practices of both India and US. Arousal of  The conflict of interest trading and market  sectors is unavoidable, but with proper regulations, adverse impact on public domain is definitely preventable. 

Finally,

In spite of having number of shortcomings, Generic drugs need to be used all over the world. In order to make healthcare cost affordable to every citizen, adopting Generic drugs is one major options available to us till now. At the same time, regulators should be cautious about conflict of interest, vigorous policy and required and meticulous observation of regulations only can insure this  highly economic market. Good quality of drug is what we need not good quality of data.

                                                    THANK YOU !!!





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