Thursday, April 27, 2017

Generic Medicine Prescription: Treat the cause and not the symptom

Generic Medicine Prescription: Treat the Cause and not the Symptom
Prime Minister Narendra Modi’s recent call for generic medicine prescription mandatorily by the physicians with a view to reducing the cost of healthcare, and the likely law surrounding it, is the culmination of three decades of effort to provide affordable healthcare to the poor. Doctors in government hospitals are mandated to prescribe only generic drugs. Moving from branded generics to generics, with most pharmacies and medical stores manned by unqualified or semi-qualified persons, would be well-nigh impossible, because 50% of drugs are combination drugs.

A number of studies conducted elsewhere in the world point out the factors influencing the generics’ prescribing behavior. While the patient’s financial status, welfare, compliance, and fear of punishment are positive factors, quality concerns, lack of regulation by Food and Drug Administration (FDA), poor recall of generic names, patient’s preference and personal experience are negative factors influencing the generics prescribing behavior.

A qualified physician checks the causes of an illness and treats the patient after a few diagnostic tests, while quacks treat on the basis of symptoms. Insights into the ecosystem of pharma health care in India will help understanding the burden of our arguments:

1. Too Many Brands, Loan licensing and Pharma-Physician Nexus 
There are about 92,000 branded generic formulations today. Loan licensing allows manufacturing of fast moving drugs (largely prescribed molecules or fixed dose combinations) yielding higher margins for the investors. A pharmaceutical representative, manager or a physician or a group of physicians with sizable clinical practice can start a pharma company easily. Such pseudo manufacturers colluding with willing physicians, under mutually agreeable terms of contract, share the gains, leaving the pain to the poor patient. Competitors with deeper pockets can easily persuade them to prescribe their products by increasing the transactional sum. This leads to a continuous escalation of marketing costs at the expense of patients.

2. Regulatory Standards 
India’s current drug regulatory mechanism has inherent inefficiencies and inadequate infrastructure. There is a vast difference in the quality of generics in India and elsewhere in the world. In the US and other well regulated markets, stringent quality control measures ensure effectiveness of generics administered on patients, through bioequivalence tests at the USFDA approved laboratory. Mere comparisons with innovator drug of chemical equivalence does not make it therapeutically equivalent. All this costs a lot and puts an entry barrier on fly-by-night operators. The technical infrastructure in India is grossly inadequate for quality testing and certainly not comparable with the West. 

Most of the generic formulations are not tested by comparing them with the leader of the branded generic formulation or the brand-name drug for bio-equivalence, and yet they are approved.  Many of the reported close to 10,000 drug companies do not have a manufacturing facility that conforms to and approved by the World Health Organization’s Good Manufacturing Practices (WHO GMP).

The loan licensing system enables start-ups having a million rupees to enter the market with their own generic, creating competing spaces at national, regional and local levels. How will the Drug Controller General of India (DCGI) ensure that the patients get the same quality of generic drug as the branded drug? A branded drug manufacturer has his reputation at stake while the generic manufacturer has little to lose.

3. Continuous Cost Escalation of Medical Education 
The pharma-physician nexus is deepening by the day and along with it are the irrational prescriptions of expensive branded drugs. The ever increasing cost of medical education, both at the graduation and specialty level, are driving the new entrants into medical practice to recover their education expenditure through unholy contracts with pharma companies. Neither the government nor the Medical Council of India is able to do anything to curtail the capitation fee system in private medical colleges, the root cause for corruption among dotors.

4. Shortage of Qualified and Trained Pharmacists in Retail Pharmacies
It is pathetic that most of the 7.5 lakh retail pharma outlets do not have qualified pharmacists at the shop floor. Even the compromising solution suggested by the government, to train the sales persons of these shops, is yet to see the light of day. What is more, the curriculum at the graduate level in our pharmacy courses does not include many of the new drugs that are recently developed. Empowering the not-so-qualified pharmacist to dispense generic drugs can do more harm than good to the patient.

5. Breaking the Pharma-Physician Nexus or Creating a New Pharma-Pharmacist Nexus? 
The other root cause of the problem lies in the hierarchy of pharmaceutical products – innovator-branded medicines, value added drugs – those that carry the same molecules with a perceptible premium and branded generics and generics, in that pecking order. Go to any corporate hospital: medicines prescribed there with the highest premium are available only in the attached pharmacy.

The contemplated legislation on compulsive generic drug prescription would have the distinct possibility of therapeutic prescription carrying the best price that would make the manufacturer-retailer nexus coexist with the physician-pharmacist nexus, making it a win-win situation for everyone – barring the patients. The solution lies not so much in law as in cleaning up the entire supply chain that includes the drug controllers.

6. Absence of Good Governance 
That there is clearly a lack of good governance is evident from the fact that the government has been unable to ensure compliance from all the stakeholders despite the presence of well-defined rules governing the manufacturing and selling pharmaceutical products in India such as the Drugs & Cosmetics Act, Voluntary UCPMP (Universal Code of Pharmaceutical Marketing Practices), MCI (Medical Council of India) etc. Yet another law makes no big difference.

Evolution or De-evolution?
The modern pharmaceutical industry as we know it today has evolved over many years and contributed significantly to the discovery and development of important drugs. The same industry has to develop future cures too. Therefore, it has to continuously evolve around investments in research and innovation. Let the industry be encouraged to continue in the evolution process. 

The Way Forward: A Prescription

  • To change this negative perception of generic drugs, all we have to do is approve every generic formulation based on a bio-equivalence test, comparing it with the reference drug (either the brand name drug or leader brand of the branded-generic drug). If this is made mandatory the quality of the generic drugs would improve significantly.
  • Ensure that a qualified and trained pharmacist, who has adequate knowledge about drugs and diseases and can improve health awareness among patients, mans all retail pharmacies.
  • In order to bring a sustainable and lasting change in behavior, introduce recognition and reward systems among physicians who prescribe more generic drugs and make the names public to accelerate the rate of generic drug prescription.
  • Strengthen the Drug Administration Department with adequate manpower to ensure compliance and establish good manufacturing practices (GMP) among all manufacturing units.
  • It must be mandatory for a loan licensee currently leveraging on outside manufacturers to manufacture in its own manufacturing unit within a specified time, failing which the unit’s license will be cancelled after the notice time. This will rationalise the number of drug manufacturing units, improve their productivity and the overall quality of generic drugs. It would also help in stopping the pharma - physician nexus.

Currently, there are an estimated 92,000 pharmaceutical products in India, of which about 60 per cent are different versions of branded-generic or generic versions of single ingredient drugs. It is necessary to impose a cap on the number of generic formulations for each single-ingredient drug. This is by no means exhaustive. It is only to start the process of thinking holistically with a singular purpose of treating the cause(s) and not merely the symptom(s).

(Ch SVR Subbarao is former Director for Marketing at Sun Pharmaceuticals Ltd and Dr B Yerram Raju is an economist and risk management specialist.)