Skip to main content

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?

Popular posts from this blog

NGT terminates chairmen of pollution control boards in 10 states (downtoearth,)

Cracking the whip on 10 State Pollution Control Boards (SPCBs) for ad-hoc appointments, the National Green Tribunal has ordered the termination of Chairpersons of these regulatory authorities. The concerned states are Himachal Pradesh, Sikkim, Tamil Nadu, Uttarakhand, Kerala, Rajasthan, Telangana, Haryana, Maharashtra and Manipur. The order was given last week by the principal bench of the NGT, chaired by Justice Swatanter Kumar. The recent order of June 8, 2017, comes as a follow-up to an NGT judgment given in August 2016. In that judgment, the NGT had issued directions on appointments of Chairmen and Member Secretaries of the SPCBs, emphasising on crucial roles they have in pollution control and abatement. It then specified required qualifications as well as tenure of the authorities. States were required to act on the orders within three months and frame Rules for appointment [See Box: Highlights of the NGT judgment of 2016 on criteria for SPCB chairperson appointment]. Having ...

High dose of Vitamin C and B3 can kill colon cancer cells: study (downtoearth)

In a first, a team of researchers has found that high doses of Vitamin C and niacin or Vitamin B3 can kill cancer stem cells. A study published in Cell Biology International showed the opposing effects of low and high dose of vitamin C and vitamin B3 on colon cancer stem cells. Led by Bipasha Bose and Sudheer Shenoy, the team found that while low doses (5-25 micromolar) of Vitamin C and B3 proliferate colon cancer stem cells, high doses (100 to 1,000 micromolar) killed cancer stem cells. Such high doses of vitamins can only be achieved through intravenous injections in colon cancer patients. The third leading cause of cancer deaths worldwide, colon cancer can be prevented by an intake of dietary fibre and lifestyle changes. While the next step of the researchers is to delineate the mechanisms involved in such opposing effects, they also hope to establish a therapeutic dose of Vitamin C and B3 for colon cancer stem cell therapy. “If the therapeutic dose gets validated under in vivo...

SC asks Centre to strike a balance on Rohingya issue (.hindu)

Supreme Court orally indicates that the government should not deport Rohingya “now” as the Centre prevails over it to not record any such views in its formal order, citing “international ramifications”. The Supreme Court on Friday came close to ordering the government not to deport the Rohingya. It finally settled on merely observing that a balance should be struck between humanitarian concern for the community and the country's national security and economic interests. The court was hearing a bunch of petitions, one filed by persons within the Rohingya community, against a proposed move to deport over 40,000 Rohingya refugees. A three-judge Bench, led by Chief Justice of India Dipak Misra, began by orally indicating that the government should not deport Rohingya “now”, but the government prevailed on the court to not pass any formal order, citing “international ramifications”. With this, the status quo continues even though the court gave the community liberty to approach i...