Generics Vs. Branded Medicines
Healthcare is included in the Constitution of Nepal as one of the fundamental rights of people. This implies that people should have easy access to healthcare facilities at an affordable price. However, healthcare costs in Nepal are not cheap. As such, medical treatment is a burden for most of the people. Furthermore, lack of medical facilities in rural and remote parts of the country has put the people there at a disadvantage, forcing them to go to Kathmandu or other major cities or even foreign countries for treatment. Concentration of medical facilities in limited areas is not desirable but the government has not paid any attention to addressing the matter.
The pharmaceutical industry is one of the lucrative industries in the world. In a country like Nepal where development infrastructure is virtually on the drawing board, domestic production of medicines is on a small scale. As such, huge quantities of medicines have to be imported from abroad annually. Generally, there are two kinds of medicines: branded and generic. Branded medicines are costlier than generic ones. This is because a lot of money has been spent on producing such medicines. The cost starts to be incurred from the time research is conducted to identify whether a certain substance is eligible to become a medicine. After research, the proposed medicine needs to be developed and tested. Further, advertising and marketing costs also remain high. Thus, a mind-boggling amount of money, estimated at USD 1.5 billion, is required to produce a single medicine.
The medicines so made are patented so that only the pharmaceutical company that produces the medicines can sell them. So such branded medicines are highly priced so as to recoup the money spent on producing the medicines, including research, development, testing and advertising/marketing expenses. Sometimes, even the expenses incurred on failed medicines have to be recouped because not all research becomes a success. The company can have monopoly on such medicines till the patent is in force. After the expiration of the patent, any company can produce generic versions of the branded medicines. So the prices of generic medicines are lower. Further, competition among pharmaceutical companies to produce such medicines further reduces the prices.
Now the question is, are generic medicines as effective as branded medicines? The effectiveness of drugs is governed by the ingredients they contain and their quantities. Both branded and generic medicines contain the same active ingredients but their inactive ingredients like excipients may differ. It may be noted that it is the active ingredients that counteract and cure a disease. However, inactive ingredients help active ingredients to perform well, for example by stabilising them for a long period of time and by successfully carrying them to the proper destination of the body. There may be some differences between these medicines in terms of flavours, colours, packaging or labelling but they are the same in effectiveness, or as near as makes no difference.
There are complaints that people are compelled to buy expensive medicines. Sometimes, they have to buy even cheap medicines at inflated prices. Some doctors prescribe medicines that are available at a particular pharmacy or that are manufactured by a particular pharmaceutical company. There are medicines manufactured under various brand names. Under the influence of medical representatives, some doctors tend to prescribe medicines of a particular pharmaceutical company for commission. Such a practice is unprofessional but is widely in vogue. The ultimate victims of such a practice are patients.
So it would be in the interests of the public if doctors make it a practice of prescribing generic medicines. But in our context, the practice is not viable under the existing circumstances because most generic medicines are not available. For example, metformin (an anti-diabetes medicine) is a generic medicine, whereas Glycomet or Glyciphage is a branded one. The problem is that if medicines are prescribed by generic name under the current circumstances, pharmacists may give branded medicines with an ingredient conforming to the generic name. So a patient with a prescription mentioning metformin may end up getting Glycomet or Glyciphage or some other medicine. This situation will turn out to be even worse that the present one.
Nepal imports most medicines from India. India has a plethora of pharmaceutical companies, some of which also manufacture generic medicines. So importing generic medicines from India or other countries is not out of the question. In the West, 85 per cent of the medicines in use are generic medicines. The US FDA (Food and Drug Administration) has stringent laws, which has ensured the effectiveness and safety of medicines, whether branded or generic.
Nepal is also considering the introduction in the market of generic medicines. A bill on public health stipulating, among other things, the requirements for writing generic names on prescriptions has also been presented before Parliament. Before endorsing the provision, there should be adequate deliberations. There is not even an iota of doubt that the introduction of generic medicines will be a boon to the people living in a poor country like Nepal as it will bring healthcare costs down to a great extent.
However, there should be a strong mechanism to ensure that generic medicines are effective and safe. The responsibility for monitoring and ensuring the quality of medicines falls on the Department of Drug Administration (DDA). If generic medicines are to be used by either importing them from abroad or manufacturing them in the country itself, DDA needs to be equipped with skilled manpower and well-equipped laboratories. If generic medicines are to be produced in the country itself, Nepal Drugs Limited (formerly Royal Drugs Limited) may be pressed into action with sophisticated equipment and technology.
The company has resumed operation after a hiatus of ten years. What with mismanagement and what with failure to abide by the good manufacturing practices of the World Health Organisation, the pharmaceutical company ceased to produce medicines in 2008. With recent revival, the company aims at producing 15 types of medicines, including capsules, penicillin-based medicines and ointments. It has its own laboratory called National Medicine Laboratory, which is responsible for the testing and analysis of medicines.
However, shifting completely to generic medicines is not possible because certain diseases such as life-threatening ailments like pneumonia, asthma and sepsis require branded medicines. A mix of branded and generic medicines may be used for the benefit of the general public. So a lot of deliberations are required before replacing branded with generic medicines.