Prime Minister Narendra Modi’s recent call for mandatory prescription of generic drugs by physicians to lower the cost of healthcare, and the likely law surrounding it, is the culmination of three decades of efforts to provide affordable health care for the poor. Doctors in public hospitals are mandated to prescribe only generic drugs. Switching from branded generics to generics, with most pharmacies and medical stores occupied by unskilled or semi-skilled people, would be nearly impossible, as 50% of drugs are combination drugs.
Numerous studies carried out elsewhere in the world highlight the factors influencing the prescribing behavior of generics. While the patient’s financial situation, well-being, compliance and fear of punishment are positive factors, quality issues, lack of regulation by the Food and Drug Administration (FDA), poor recall of names generics, patient preference and personal experience are negative factors influencing generic prescribing behavior.
A qualified doctor checks for the causes of a disease and treats the patient after a few diagnostic tests, while quacks treat on the basis of symptoms. An overview of the pharmaceutical healthcare ecosystem in India will help understand the weight of our arguments:
1. Too many brands, loan licenses and link between pharmacists and doctors
There are approximately 92,000 branded generic formulations today. Loan licensing enables the manufacture of rapidly evolving drugs (widely prescribed molecules or fixed dose combinations) generating higher margins for investors. A pharmaceutical representative, a director or a doctor or a group of doctors with a large clinical practice can easily set up a pharmaceutical business. These pseudo-manufacturers in collusion with consenting doctors, under mutually acceptable contract terms, share the gains, leaving the pain to the poor patient. Competitors with larger pockets can easily persuade them to prescribe their products by increasing the transaction sum. This leads to a continuous escalation of marketing costs to the detriment of patients.
2. Regulatory standards
India’s current drug regulatory mechanism has inherent inefficiencies and inadequate infrastructure. There is a big difference in the quality of generics in India and elsewhere in the world. In the United States and other well-regulated markets, strict quality control measures ensure the efficacy of generics administered to patients, through bioequivalence testing in the USFDA-approved laboratory. Simple comparisons with an innovative drug of chemical equivalence do not make it therapeutically equivalent. All this is expensive and puts a barrier to entry for ephemeral operators. The technical infrastructure in India is grossly insufficient for quality testing and certainly not comparable to that in the West.
Most generic formulations are not tested by comparing them with the leading branded generic formulation or the brand name drug for bioequivalence, and yet they are approved. Many of the nearly 10,000 pharmaceutical companies reported do not have a manufacturing facility that conforms and is approved by the World Health Organization (WHO GMP) good manufacturing practices.
The loan licensing system allows start-ups with a million rupees to enter the market with their own generic, thus creating competing spaces at national, regional and local levels. How will the Drug Controller General of India (DCGI) ensure that patients get the same quality of generic drug as the brand name drug? A brand name drug maker has its reputation on the line, while the generic drug maker has little to lose.
3. Continued increase in medical education costs
The bond between doctors and pharmacists is growing deeper by the day and, with it, irrational prescriptions for expensive brand name drugs. The ever-increasing cost of medical education, both at the graduate and specialty level, is pushing new entrants into medical practice to recover their education expenses through ungodly contracts with pharmaceutical companies. Neither the government nor the Medical Council of India is in a position to do anything to reduce the capitation fee system at private medical schools, the root cause of corruption among doctors.
4. Shortage of qualified and trained pharmacists in retail pharmacies
It is pathetic that most 7.5 lakh retail pharmaceutical outlets do not have qualified pharmacists in the shop floor. Even the compromising solution suggested by the government, to train the salespeople of these stores, has not yet seen the light of day. In addition, the graduate curriculum of our pharmacy courses does not include many of the newer drugs recently developed. Empowering the less qualified pharmacist to dispense generic drugs can do more harm than good to the patient.
5. Break the link between pharmacists and physicians or create a new link between pharmacists and pharmacists?
The other root cause of the problem lies in the hierarchy of pharmaceuticals – innovative brand name drugs, value added drugs – those that carry the same molecules with a noticeable premium and the generic and branded generics, in that hierarchical order. Appointment at any company hospital: the drugs prescribed there with the highest premium are only available in the adjoining pharmacy.
The envisaged legislation on compulsive prescription of generic drugs would have the distinct possibility of a therapeutic prescription at the best price which would coexist the manufacturer-retailer link with the doctor-pharmacist link, which would make it a win-win situation for everyone. – with the exception of patients. The solution does not lie so much in the law as in cleaning up the entire supply chain, including drug controllers.
6. Lack of good governance
That there is clearly a lack of good governance is evident from the fact that the government has not been able to ensure the respect of all stakeholders despite the presence of well-defined rules governing the manufacture and sale of products. pharmaceuticals in India such as drugs and cosmetics. Law, voluntary UCPMP (Universal Code of Pharmaceutical Marketing Practices), MCI (Medical Council of India) etc. Another law does not make a big difference.
Evolution or De-evolution?
The modern pharmaceutical industry as we know it today has evolved over many years and has contributed significantly to the discovery and development of important drugs. The same industry must also develop future remedies. Consequently, it must constantly evolve around investments in research and innovation. That the industry be encouraged to continue in the process of evolution.
The way forward: a prescription
To change this negative perception of generic drugs, it suffices to approve each generic formulation on the basis of a bioequivalence test, comparing it with the reference drug (either the brand name drug or the leading brand of the generic drug of Mark). If this were to become mandatory, the quality of generic drugs would improve considerably.
Ensure that a qualified and trained pharmacist, who has adequate knowledge about drugs and diseases and can improve patient health awareness, manages all retail pharmacies.
To bring about lasting and lasting behavior change, introduce recognition and reward systems to physicians who prescribe more generic drugs and make names public to speed up the pace of generic drug prescribing.
Strengthen the drug administration department with sufficient staff to ensure compliance and establish good manufacturing practices (GMP) in all manufacturing units.
It must be mandatory for a loan licensee currently using external manufacturers to manufacture in their own manufacturing facility within a specified timeframe, otherwise the unit license will be canceled after the notice period. This will rationalize the number of drug manufacturing units, improve their productivity and the overall quality of generic drugs. It would also help to break the link between pharmacist and doctor.
Currently, there are around 92,000 pharmaceuticals in India, of which around 60 percent are different versions of generic or branded generic versions of single ingredient drugs. There is a need to put a cap on the number of generic formulations for each single ingredient drug. This is by no means exhaustive. It is only to begin the process of holistic thinking with the sole purpose of addressing the cause (s) and not just the symptom (s).
(Ch SVR Subbarao is the former Director of Marketing at Sun Pharmaceuticals Ltd and Dr B Yerram Raju is an economist and risk management specialist.)