The World Bank Report released on April 07, 2023 highlights that patients’ Out-of-Pocket (OoP) expenses as a percentage of their total healthcare expenditure in India still accounted for as high as 50.59%. This means that patients in India generally pay for the majority of their healthcare costs themselves, rather than through insurance or government funding. The high level of OoP expenses in India has been a major problem for many patients, even today. Studies indicate it often leads to financial hardship, especially for low-income families.

A number of factors contribute to the high level of OoP in the country, as a whole, with regional variations. According to several studies, the healthcare costs in India are rising faster than inflation, making it increasingly difficult for more people to afford the care they need, especially for life threatening ailments, such as cancer.

Different union governments while in power have taken several steps to address this problem, such as, in 2018, the launch of the Pradhan Mantri Jan Arogya Yojana (PMJAY), a national health insurance scheme. It provides free coverage for poor and vulnerable families. The PMJAY is expected to have helped in reducing OoP for some patients, but it is not yet clear how much of an impact it has had overall.

On April 24, 2017, I asked on this blog – would drug ‘Prescriptions in Generic Names Be Made A Must in India?’. Interestingly, in August 2023, a new circular from the National Medical Commission (NMC) notified professional conduct regulations for Registered Medical Practitioners (RMP), including guidance to doctors on drug prescriptions.  This has raised a furor, as it were, among many medical practitioners and their associations. In this article, I shall deliberate on the pros and cons of this decision and its practicality in India. Let me start with the rationale behind such thinking, as I see it.

The rationales behind drug prescription only in generic names in India:

As I see it, there are several rationales behind doctors prescribing drugs only under generic names in India. Here are some of the most important ones:

• Cost savings: Generic drugs are typically much cheaper than brand-name drugs. This is because generic drugs do not have to go through the same expensive clinical trials and marketing campaigns as brand-name drugs. As a result, they can be sold at a much lower price. This can save patients a significant amount of money, especially for expensive medications. 

• Increased access to medicines: The lower cost of generic drugs can make them more accessible to people who might not otherwise be able to afford them. This is especially important in India, where a large proportion of the population lives below access, the poverty line. Generic drugs can help to ensure that everyone has access to the medicines they need. 

• Improved competition: The availability of generic drugs can lead to increased competition in the pharmaceutical market. This can drive down prices even further and benefit patients.

• Reduced risk of counterfeit drugs: Generic drugs are regulated by the government and must meet the same quality standards as brand-name drugs. This means that patients can be confident that they are getting a safe and effective product, regardless of whether it is a generic or brand-name drug. Counterfeit drugs, on the other hand, are often made with substandard ingredients and can be dangerous to take. By prescribing generic drugs, doctors can help to reduce the risk of patients getting counterfeit drugs. 

• Transparency and accountability: In addition to these benefits, prescribing drugs under generic names can also help to promote transparency and accountability in the pharmaceutical industry. When doctors prescribe drugs under generic names, it is easier for patients to compare prices and choose the best option for their needs. This can help to drive down prices and improve the quality of care. 

A draft regulation was notified in 2022 for comments by all concerned:

For this purpose, a draft regulation was issued by the National Medical Commission (NMC) on May 23, 2022, for comments by all concerned, before it becomes mandatory in 2023. The NMC has also stated that it will take steps to ensure that the quality of generic drugs is maintained. The NMC will work with the Drug Controller General of India (DCGI) to ensure that generic drugs meet the required quality standards.

The final notification goes beyond drug prescription in generic names:

On August 03, 2023, The National Medical Commission (NMC) notified the professional conduct regulation for Registered Medical Practitioners (RMP). It not only provides guidance to avoid branded generic drugs and prescribing drugs with generic, non-proprietary and pharmacological names only, but also, restricts doctors from getting involved in any third-party educational activity like Continuing Professional Development, seminar, workshop, symposia, conference, etc., which involves direct or indirect sponsorships from pharmaceutical companies or the allied health sector. 

It justified its decision by saying, “India’s out-of-pocket spending on medication accounts for a major proportion of public spending on health care. Further, generic medicines are 30% to 80% cheaper than branded drugs. Hence, prescribing generic medicines may overtly bring down health care costs and improve access to quality care.” The notification also provided guidance on telemedicine consultation and prescriptions.  

The Indian Medical Association (IMA) Protested against it:

The Indian Medical Association (IMA) submitted a memorandum to the Indian regulator, the National Medical Commission (NMC), on February 7, 2023, protesting against the compulsory prescription of generic drugs. The memorandum argued that the regulations would harm patients and doctors, and that they were being implemented without proper consultation with stakeholders.

The IMA also stated that the regulations would violate the fundamental right to freedom of speech and expression of doctors. The memorandum said that doctors should be free to prescribe drugs based on their medical judgment, and that they should not be forced to prescribe generic drugs.

The IMA’s protest is significant because it is the first major challenge to the NMC’s regulations on compulsory prescription of generic drugs. The protest could have a significant impact on the implementation of the regulations, and it could also lead to changes in the regulations.

It is important to note that the IMA is not the only organization that has expressed concerns about the NMC’s regulations. Several other medical associations have also expressed concerns, and some doctors have also spoken out against the regulations.

The controversy over the NMC’s regulations is likely to continue for some time. It is important to note that there are valid concerns on both sides of the issue. It is also important to remember that the regulations are still in the early stages of implementation, and that it is too early to say what their long-term impact will be.

A few reasons why doctors in India may be hesitant to prescribe drugs under generic names. 

Here are some of the most common reasons:

• Lack of awareness: Some doctors may not be aware of the benefits of generic drugs. They may believe that brand-name drugs are always better than generic drugs, even though this is not always the case. 

• Influence from pharmaceutical companies: Pharmaceutical companies often give doctors incentives to prescribe their brand-name drugs. This can create a conflict of interest for doctors, who may be more likely to prescribe brand-name drugs even if they believe that generic drugs are just as effective.

• Patient demand: Some patients may specifically ask for brand-name drugs, even if generic drugs are available. This can put pressure on doctors to prescribe brand-name drugs, even if they believe that generic drugs are a better option.

• Quality concerns: There have been some cases of counterfeit generic drugs being sold in India. This can lead to doctors being hesitant to prescribe generic drugs, as they may be concerned about the quality of the drugs.

Some ways to encourage doctors to prescribe generic drugs:

• Educate doctors about the benefits of generic drugs. Doctors need to be aware of the benefits of generic drugs in order to be willing to prescribe them. They should be taught about the cost savings, increased access, and improved quality of generic drugs.

• Reduce the influence of pharmaceutical companies on doctors. Pharmaceutical companies should not be allowed to give doctors incentives to prescribe their brand-name drugs. This would help to ensure that doctors are prescribing drugs based on the best interests of their patients, rather than on financial considerations. 

• Encourage patients to ask for generic drugs. Patients should be aware of the benefits of generic drugs and should ask their doctors to prescribe them whenever possible. This will help to create a demand for generic drugs and encourage doctors to prescribe them. 

• Improve the quality control of generic drugs. The government should take steps to improve the quality control of generic drugs in India. This would help to reduce the risk of patients getting counterfeit drugs. 

By taking these steps, we can encourage doctors to prescribe generic drugs and make them more accessible to patients. This would help to save patients money, improve access to medicines, and reduce the number of counterfeit drugs in circulation.

Conclusion:

I now revert to this month’s notification of the National Medical Commission (NMC) on the professional conduct regulation for Registered Medical Practitioners (RMP), providing  new guidance for drug prescriptions in India. It clearly indicates that doctors should avoid prescribing branded generic drugs, instead prescribe drugs with generic, non-proprietary and pharmacological names only. ‘However, in the case of drugs with a narrow therapeutic index, biosimilars, and similar other exceptional cases, the practice of prescribing generic names only, can be relaxed,’ it elaborated.

Weighing the pros and cons of this notification, I reckon, despite the reasons articulated by doctors and their associations, besides the branded generic manufacturers, there are many benefits to prescribing drugs under generic names only. Generic drugs are typically much cheaper than brand-name drugs, and they are just as effective. They can also help to reduce the number of counterfeit drugs in circulation, besides several other benefits, as cited above. As a result, doctors should be encouraged to prescribe generic drugs whenever possible. Let me hasten to add, changing the prescribing practices of doctors and addressing concerns about the quality of generics can be a complex and gradual process.

By: Tapan J. Ray      

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.