A recent set of guidelines issued by the National Medical Commission has drawn sharp reactions from the Indian medical fraternity. The rules make it mandatory for doctors to prescribe generic drugs over their branded counterparts. It says that “drugs prescribed by RMP or bought from the pharmacy for a patient should explicitly state the generic name of the drug.”
By forcing the doctors to prescribe only generic drugs, the NMC would be seriously compromising the healthcare system of the country, which at this time needs much greater attention. Besides, research and development (R&D) in generic drugs needs investments, which pharma companies are usually not willing to make for fear of effective return.
There are several reasons why India is not ready for these latest guidelines.
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Understand by example: dermatology
In dermatology, several internal diseases are treated topically as skin is the first marker of various ailments. There is also cosmetic dermatology, which is in vogue today but generics in cosmetic products don’t exist as of now. A doctor can suggest salts but leaving the patient entirely on the wisdom of a chemist who may sell a brand of their choice is not advisable either.
If these suggestions become binding, then professional indemnity of dermatologists should be doubled. In the backdrop of absence of studies and documentation, doctors have understood after years of hard work what a specific brand can achieve with certain patient conditions. In many cases, branded medicine doesn’t work on certain individuals as the human body is a complex system and works differently for all.
As a practising dermatologist with 12 years of experience, I have never used injectable Botulinum Toxin from any brand apart from the one that is USFDA approved. Today, it has several competitors in market that are much cheaper. But studies on their efficacy along with the USFDA approval is lacking. And yes, I will have nightmares before using them. Similarly, even the thought of leaving a simple Vitamin C serum to a chemist’s whim can take the practise of dermatology behind by a decade because several formulations available in the market are combinations as generic isn’t available while several others don’t work.
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The bottlenecks
The production, prescription and marketing of indigenously produced pharma products have been subjected to a series of roadblocks. While this is so, the domestic manufacturers have also not covered themselves in glory at times. On their part, successive governments have not been able to come up with a cogent, long-term, tamper-proof pharma policy that will spur research and growth to alleviate the health-related woes of teeming millions who need affordable but dependable drugs.
Looking at the issues faced by multitude of patients, the NMC seems to have invoked the Biblical adage of Midice, cura te ipsum (Physician, heal thyself). The guidelines for doctors by the NMC don’t restrict itself to drug prescription. They cover several aspects of medical practice and outline certain limits aimed at promoting ethical practice of the profession. These include pressing for judicious use of social media, writing prescriptions in legible, capital letters, avoiding attendance at conferences sponsored by pharma companies and accepting gifts and availing other benefits from corporate entities.
While these and some other suggestions, read mandates, may invite the ire of a section of medical practitioners, the directive to prescribe generic medicines can lead to controversies, requiring wider consultations and a second look.
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Why generic drugs are not a panacea
An experienced physician would confirm that not all drugs and externally applicable ointments react to illness in a similar manner. Some antibiotics take a week’s time to have effect while some reduce infection in a couple of days. Festering fungal infections are known to have developed drug-resistance and do not respond to generic medicines, oral or external application. It has also been found that in many cases, anti-fungal treatment is related to the nature of the surroundings, skin texture, climatic conditions and nutritional levels of patients. All drugs do not work in the same manner and failure rates are as much as 50 per cent in some cases.
Medical cases such as chronic pulmonary aspergillosis (CPA), a chronic progressive infection that destroys lung tissues in non-immunocompromised patients such as those who were infected with Covid19 infection, has been on the rise. It’s been documented that generic drugs were not as effective as the innovator drug. And as a practising dermatologist, many times, I have come across similar cases. Hence, there is urgent and strong need to do research in this field before any generic drug is administered, especially when it comes to threatening diseases.
While the intent of the government in bringing laws to promote wider use of generic drugs is good and above suspicion, the content of the NMC guidelines needs a much-detailed revision. The generic drug market is huge and the stakeholders are many. Before introducing a generic drug, it has to undergo a series of stringent tests like research validation, production standards, successful clinical trials and sufficient financial calculations on balancing between return on investment and affordability.
It has also been observed that several pharma manufacturers expect huge loans from banks and other lending institutions and come out with generic medicines that meet temporary order-based market requirements. At times, even larger players in the pharma sector resort to stability testing, which only meets shelf-life tests and do not meet the quality control standards of multinational corporations that have extremely stringent quality standards. Again, those Indian pharma companies that have joint ventures with foreign companies seem to be interested only in production for export purposes. This gives them greater profits and better return on investments as they do not have to spend on research and marketing.
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What must be done
The government needs to intervene and convene a national debate on the use of generic drugs, manufacture of very high-quality products at an affordable price and invest heavily in research and development. Tax incentives and centralised research facilities can also be thought of.
On their part, the pharma companies also need to show sincerity in their activities and subject themselves to stricter controls if they truly believe that they are in a business that literally touches the lives of patients.
As for doctors, the need to remember their ethics and duty towards humanity should precede their urge to recover the cost of their education. It would be better if the representatives of all stakeholders, the physicians, pharma companies, hospitals and the beneficiaries of the healthcare system—the people, sit together and thrash out the issue.
Dr Deepali Bhardwaj is a dermatologist, anti-allergy specialist, laser surgeon and internationally trained aesthetician. She tweets @dermatdoc. Views are personal.
(Edited by Anurag Chaubey)