Will Onset of Generic Medicines Ensure Quality Control?

In the light of new schemes being introduced, Prime Minister Narendra Modi indicated that there could soon be a legal framework wherein doctors will have to prescribe generic medicines. He also hinted on starting the Pradhan Mantri Bharatiya Janaushadi Pariyojana so that cheaper medicines are available for those who need them. As of February this year, 762 Pradhan Mantri Bhartiya Janaushadhi Kendras are functioning in over 26 states/union territories.

The PM went on to talk about how doctors wrote prescription in a way that people don’t understand what is written and have to buy them from private medical stores at a higher price. He said prescribing generic drugs will give the poor access to medicines which are cheaper but equivalent to their branded counterparts.

He hopes that with the legal framework making prescription of generic drugs mandatory, the patient will be able to buy only generic medicine, which puts the decision on him, not to buy other branded medicine and the doctor too, will have to prescribe in a way where his/ her hand writing is clear.

The Centre had recently introduced a health policy, which reduced the costs of several medicines and injections for ailments like including tuberculosis, cancer and cardiac diseases, up to 15%. The decision taken after meetings with several pharmaceutical companies, was announced by National Pharmaceutical Pricing Authority (NPPA), drug price regulator, in a notification on its website. The PM also went on to say how doctors and hospitals are less in our country, making healthcare expensive, especially for those in the middle class and lower class sector. He also stressed on the importance of preventive healthcare in light of the Swacchta Abhiyaan and the practice of yoga being an important part of wellness.

According to AKCDA (All Kerala Chemists and Drugs Association) Ernakulam District Secretary Saiju Abraham says, “Some medicines whether branded or generic, are of good quality. Now, there are times when the same medicine is available for INR 2 a capsule to INR 20 a capsule. But, there will be difference in quality in these medicines. Some manufacturers of the cheaper drugs may not follow Good Manufacturing Practices. The real question is whether or not the medicine will cure the patient. The government needs to analyse generic medicines and ensure that they are of good quality. Because quality medicines are produced after years of research and hence branded medicines tend to cost more.”

“This is a good movement as it will make many medicines available at 1/5th of its cost to the poor. The only thing that needs to be checked, is whether or not the manufacturer of the generic medicine is good and is maintaining quality of the medicine. Checking quality and certification of the manufacturer is very important. So far Jan Aushadhi has been dispensing only good quality medicines. The standards of these need to be compared with international brands. Good quality paracetomol has the shelf-life of three years, whereas if the quality isn’t good, you could be eating chalk powder instead of paracetamol after a year of its purchase,” says Doctor Girish Kumar, Professor and Head of Emergency Medicine Department, Amrita Institute of Medical Sciences.

“There are already two regulations in place with regards to generic medicines. One, under the Drugs and Cosmetics Act, name of the generic medicine should be prominent or equally big as the brand name. Second, under ethical guidelines, doctors should prescribe medicines under their generic names. But neither pharmaceutical companies or doctors are being pulled on account of this. Doctors can argue that while prescribing a combination of drugs, branded medicines work the best. However, currently there is a legal vacuum wherein there is not statute making prescription of generic drugs compulsory. This move could assure patient safety as very often, when we switch doctors or move to another state, a particular branded medicine may not be available and so, the new doctor you are consulting with, may get confused with regards to the strength of the medication, etc. This move is also important as it allows the customer to decide as to which generic medicine to opt for. Very often, the highest price branded medicines are the top selling ones as doctors too, prescribe the medicines that benefits them the most. However now, it is on the government to ensure that the quality of these generic medicines are good or else it will give rise to problems, says K Gopakumar, Visiting Fellow at the Inter University Centre for Intellectual Property Rights.

Jimmy Matthew, Clinical Professor at Amrita Institute of Medical Sciences says, “Generic medicines have been available everywhere. The difference between regular drinking water and packaged or bottled water is the same as generic medicine and branded ones. But the move doesn’t make much sense unless branded medicines are banned. For that to happen, the entire healthcare system needs to be centralised or run by the government. At the moment when the whole healthcare system runs on the model of a business in a capitalist environment, executing this could be difficult unless there is a high level scrutiny on the quality of these generic medicines. What doctors at the best can do in this scenario is, prescribe a generic drug and list two or three company names to make sure that the patient buys quality medicines. Yes, this could benefit the poor. But when the power to upkeep quality of the medicines lies in the hands of the hospitals and the government, the system can easily be corrupted. A proper system needs to be devised where in such an order can be executed properly.”

Generic or branded medicines- without quality control, ultimately it is the patient who suffers. While regularising prices of medicines is a good idea, the execution should be well-planned to avoid chaos.

Cover image courtesy: Narendra Modi CC BY 2.0 via Wikimedia Commons

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