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Generic medicines in a digital age (.hindu )

We need a legal mechanism to ensure that all generics are of the same standard as the innovator product

The Prime Minister’s recent announcement on making it mandatory for doctors to prescribe only the generic name, and not brand name of a drug, has led to a flutter. If enacted, the move will make it illegal for Indian doctors to write out a prescription for the trademark of the drug, forcing them to mention the chemical name instead. If implemented properly, the hope is that pharmacists will fill the prescription with the cheapest generic drug in the market rather than being forced to dispense a more expensive brand as prescribed. Whether pharmacists will play by the book is anybody’s guess.

Are all generic drugs equal?
A more pressing question at this stage is whether all generic medicines in India are of equal quality. The U.S. and the European Union have ensured that generic drugs are therapeutically equal to the innovator drug by making bioequivalence (BE) testing compulsory. This means that generic formulations are tested on healthy volunteers to ensure that they have the same physiological characteristics as their innovator counterparts. These BE studies are much cheaper and carry little risk when compared to clinical trials conducted by the company that gets approval for the innovator product. Once bioequivalence is established, a generic drug is legally certified to be of the same quality to replace the innovator product and can therefore be interchanged for the innovator product. Even the World Health Organisation (WHO) and Médecins Sans Frontières (MSF) purchase only bioequivalent drugs for their programmes. Until earlier this month, India mandated BE studies for only those formulations seeking approval within four years of the innovator product getting approval. As a result, most generic drug manufacturers sought marketing approval from the fifth year onwards, effectively evading the requirement of conducting BE studies. On April 3, the Ministry of Health finally amended the Drugs & Cosmetics Rules to make BE testing of all highly soluble drugs compulsory. It is a much welcome move.

What of the quality of generics approved prior to April 3? Did the manufacturers of these generic drugs voluntarily conduct BE studies? We do not know. If there is no proof of bioequivalence, should doctors be forced to make this choice? The ethical answer is a simple no. If the government wants to make the prescription of generics compulsory, it needs to put in place a legal mechanism to guarantee that all generics, especially those introduced prior to April 3, are bioequivalent to the innovator product. It would be unconscionable to restrict doctors to prescribe drugs which they know do not work as promised.

At the very least, the government should require companies to self-certify their drugs to indicate whether they are in fact bioequivalent. A simple logo on the drug’s packaging to indicate whether a drug has been tested for proof of bioequivalence, along with the trial ID number listed on the Clinical Trials Registry India, should be made mandatory.

Even presuming successful BE studies, a drug can fail for a variety of reasons. It may lack stability and break down due to heat or humidity. These substandard drugs are a dangerous problem, especially in government-run hospitals.

Drug quality in India
According to the government’s most recent survey of the quality of drugs in India, 10% of all drugs from ‘government sources’ tested NSQ, or not of standard quality. A NSQ drug will compromise patient health. These numbers are shocking. An earlier report of the Comptroller and Auditor General had revealed that the Armed Forces Medical Stores Depot, which serves armed forces personnel, had reported the percentage of locally procured drugs that were substandard at as high as 32% in one year!

The challenge for the government is to balance its policy objectives of taking the power of the doctor away to prescribe brand name drugs with the reality that generic drugs in India are of questionable quality. The solution does not lie in more laws, but in providing more information to the consumer. Drug regulators in India have a vast trove of information on substandard drugs which they need to release into a searchable database. This is easier said than done because India has 36 drug regulators — one for each State/Union Territory and the Central regulator. Each of them conducts periodic testing of samples drawn from pharmacies. This testing generates three data sets which need to be publicly available. The first is the laboratory test report, the second is the investigation report by drug inspectors of drugs which have failed testing, and the third is the criminal complaint filed in court against the manufacturer along with the final judgment of the court. If this information is made available over the Internet, the government will truly empower hospital procurement officers, pharmacists and patients with information required to avoid products of manufacturers with a poor quality record.

For an IT bridge
The government must seriously consider using IT tools to network all 36 drug regulators into one integrated national database. This can then be accessed by every citizen over a smartphone. The essence of the ‘Digital India’ initiative is to empower the citizen. What better way to do this than to provide them with information that will protect them from substandard drugs?

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