For decades psychotropic drugs have courted controversies pertaining to their 'voraciously profitable' manufacture by pharma companies and the encouragement by doctors as treatments for various ailments. What promise do these drugs offer the makers and the consumers? Aashruti Kak explores.
Psychotropic drugs play a very vital role in patient welfare and therapy. Their properties have mystified the 'unwell' as well as the healthy world over. Unfortunately, it is the blatant misuse of these drugs that has time and again threatened patient access to innumerable treatments across the globe.
A psychotropic (or psychoactive) drug acts chiefly on the central nervous system (CNS), altering brain function and resulting in temporary changes in perception, mood, consciousness and behaviour, which is why, taking in view the consequences entailed in the use of such drugs, it becomes very necessary for respective governments of the world to regulate the manufacture, possession, and use of these drugs (other than illegal drugs and prescription medications).
Four major groups that come under the banner of psychotropic drugs are—hallucinogens, antipsychotics, depressants and stimulants, which may often cross overlap with other categories, as they produce more than one type of effect. Other mood affecting drugs may fall in the category of antidepressants, antipsychotics, mood stabilisers and tranquilisers, which are vital to the practice of psychiatry.
Some of the well known drugs in the global market are Prozac (antidepressant from Eli Lilly), and Zoloft (antidepressant by Pfizer), Paxil (antidepressant from GlaxosmithKline), Zyprexa (antipsychotic drug from Eli Lilly), and morphine (derived from opium for pain management). Other substances extracted from opium for medicinal use are codeine and dihydrocodeine (bulk opiates predominantly for pain relief), and pholcodine (antitussive—cough suppressant); oxycodone, hydromorphone, diamorphine, and buprenorphine HCL (specialist opiates for pain relief).
Other controlled drugs include methadone (for addiction), fentanyl, alfentanil, sufentanil (for pain relief), and methylphenidate (for Attention Deficit Hyperactivity Disorder—ADHD).
An affluent market
Globally, there are two sorts of psychotropic drug markets-open and closed. Open markets comprise countries with limited or no domestic capabilities that rely on imported narcotics. Closed markets comprise countries with adequate domestic sources of narcotic drugs that normally do not import and are generally inaccessible to foreign manufacturers, for instance Australia, Argentina, Belgium, Brazil, China, France, Hungary, Iran, Japan, Norway, Portugal, Slovakia, South Africa, Spain, Turkey, United Kingdom, USA.
Since the psychotropic drugs segment is very vast, the markets are quite fragmented. According to ORG IMS, a research based consulting services, the antidepressant market contributes Rs 352.1 crore to the total Indian pharma market and is growing at 3.4 percent annually. The table below lists the companies active in the market.
An example of the ever expanding psychotropic drug market would be the sharp rise in the use of ADHD drugs in the US. According to a study in Health Affairs, a bi-monthly policy journal in the US, the use of ADHD drugs skyrocketed between 1993 and 2003, the prescription of such drugs nearly quadrupled, while global spending on them increased by a factor of nine.
Most of the prescription cough suppressants contain codeine or hydrocodone eg Piramal Healthcare's Phensedyl and Pfizer's Corex. The narcotic cough market is flourishing like never before, so much so, that in June 2008 Phensedyl toppled Novartis's pain killer brand Voveran to emerge as the country's largest selling drug. Before that Phensedyl was the eighth largest brand in May the same year. Although, analysts and doctors may feel that this could be attributed to a surge in viral infection and cough and cold associated with the monsoon, which is given; but there is more to the picture than that. It is widely known by all that most cough syrups are abused by drug addicts, because the codeine in the syrups can get consumers addicted. Other cough suppressant brands in the market are Codokuff by German Remedies, Tossex by Cipla and Codeine Linctus by Zydus.
"Generally, the growth drivers of this market are demographic, increase in awareness, availability and accessibility of medication, and new uses or indications for currently available drugs," says a Sun Pharma spokesperson. In addition, off label use, and increase in consumers can also be attributed as some of the growth factors of this market. Off-label prescribing is quite rampant world over as doctors give patients amphetamines and psychotropic drugs (eg ADHD or antidepressant drugs such as Adderall, Ritalin and Wellbutrin) for weight loss.
Drug control framework
A psychotropic drug manufacturing company needs to operate in a highly regulated environment, and needs to update its standards regularly with ongoing assessments by the appropriate authorities.
"In the US, the Drug Enforcement Administration (DEA) is responsible for suppressing illegal drug use and distribution by enforcing the Controlled Substances Act. In India, the Narcotic Drugs and Psychotropic Substances (NDPS) Act of 1985 (subsequently amended) sets out the statutory framework for drug law enforcement. The Narcotics Control Bureau administers this act," explains the Sun Pharma spokesperson. He goes on to say that some precursor chemicals used for the production of illegal drugs are also controlled substances in many countries, even though they may lack the pharmacological effects of the drugs themselves. Substances are classified according to schedules and consist primarily of potentially psychoactive substances. The controlled substances do not include many prescription items such as antibiotics.
Some US states have statutes against healthcare providers self-prescribing and/or administering substances listed in the Controlled Substance Act schedules. This does not forbid licensed providers from self-prescribing medications not on the schedules.
The Sun Pharma spokesperson continues, "In India, the Drugs and Cosmetics Act of 1940 regulates the manufacture and domestic distribution of psychotropic substances, whereas the Narcotic Drugs and Psychotropic Substances (NDPS) Act of 1985 (subsequently amended) sets out the statutory framework for drug law enforcement. The Act is designed to fulfil India's treaty obligations under the above mentioned international conventions." Under the provisions of the Act, the Narcotics Control Bureau was established, which became the central authority for the purpose of coordinating and exercising powers and functions of the Government under the Narcotic Drugs and Psychotropic Substances Act.
In the US, in addition to the FDA's Good Manufacturing Practices requirements (CFR 21), drug law enforcement is under the purview of the Controlled Substances Act.
India is a signatory to all three UN drug control conventions, namely, the Single Convention on Narcotic Drugs 1961 (as amended by the 1972 Protocol), the Convention on Psychotropic Substances 1971 and the United Nations Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances, 1988. India is the only country currently producing licit opium gum for medical and scientific purposes for domestic needs and for export under the terms of the 1961 Single Convention.
Strategising growth
A great example of companies taking advantage of the inflating psychotropic drug market is Sun Pharma's acquisitions of three international controlled substances businesses. In 2005, Sun Pharma acquired a facility in Hungary authorised to make controlled substance APIs, starting from the initial stage, ie poppy farming.
In the same year, the company acquired a brand new manufacturing site in New Jersey, equipped with special suites for the manufacture of controlled substances finished dosages. And most recently, in November 2008, it acquired Chattem Chemicals, which is registered with the US Drug Enforcement Administration (DEA) as a narcotic raw material importer.
Chattem is registered with the US Drug Enforcement Administration (DEA) as a narcotic raw material importer. This import registration includes four controlled substance products listed in Schedule 2: methamphetamine, phenylacetone, raw opium and concentrate poppy straw. Additionally, it is also licensed by the DEA to manufacture Schedule 1 to 5 controlled substances. At its facility spread over 6.5 acres in Chattanooga, Tennessee, Chattem employees 60 people and manufactures a variety of active pharmaceutical ingredients (APIs) with a focus on controlled substances. For the year ending June 2008, Chattem is estimated to have sales of USD 26 million.
Other than Sun Pharma's intentions of being an active player in the pain management segment in the US, this acquisition reflects another objective behind the move. "The statutes under the Controlled Substances Act prohibit the import of controlled substance API. Chattem Chemicals import quota allows the import of intermediates of API from elsewhere in the world, including our Alkaloida subsidiary in Hungary, and allows for further processing," explains the Sun Pharma spokesperson. According to current regulations in the US, companies cannot import substances such as morphine. However, certain companies are permitted to import concentrated poppy straw (processed from poppy). Sun Pharma plans to process poppy into poppy straw at its Hungary facility and then import it to the US. This will be later converted into an API at the Chattem facility and later into a final dosage form at its New Jersey unit. Internationally, the company is competing with Mallinckrodt Pharmaceuticals and Johnson Matthey
Whether psychotropic drugs are a boon or a bane will always remain a matter of ethical discussion. Many national and international forums have various reasons to believe that although these drugs have relieved majority of the distress and pain of patients worldwide, they have enormous gaping holes that reek of uncertainty when it comes to regulations, distribution, and most importantly the mistrust that consumers feel towards pharma companies.
One of the few smoke signals that arose regarding the latter were when after targeting depressed adults, pharma companies came up with the idea of selling 'happy pills' to healthy people to 'prevent depression'-also known as 'early intervention'. Much later, the companies surpassed all logic when they announced that the FDA had approved Prozac for dogs in early 2007, claiming that even dogs have chemical imbalances in the brain.
Irrespective of the uncontrolled proliferation of drug abuse world wide, governments need to tighten regulations very strategically so that they do not hamper the access to psychotropic drugs by being overly restrictive.
According to WHO estimates, severe under-treatment is reported in more than 150 countries, both developing and industrialised, accounting for about 80 percent of the world's population. Keeping that in mind, WHO developed the Access to Controlled Medications Programme (ACMP) in consultation with the International Narcotics Control Board (INCB). The programme aims to improve legitimate medical access to all medications controlled under the drug conventions.
As suggested by WHO, there are many ways in which countries can improve access to psychotropic drugs. Mental health policies need to contain well-defined strategies for improving access to essential psychotropic drugs. Legislation should be supportive of access, rather than obstructing it. Selecting the most needed drugs for good quality mental health services and developing standard treatment guidelines should also be part of the agenda.
Prices of psychotropic medicines have to be affordable to users and health systems, keeping in mind their often chronic use. Good quality mental healthcare requires more than information and prescriber training about psychotropic medicines—their appropriate use is a basic condition. And most importantly, systematic assessment and monitoring are very essential in order to continuously maintain and improve access.
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